
Search Clinical Trials
Below please find a list of studies actively recruiting volunteers at one of the following GHUCCTS institutions: Georgetown University, Howard University, MedStar Health Research Institute, or Washington DC VA Medical Center. Please enter your search criteria below to help find a study for you. If you have any questions, please email us or call us at 301-560-2963.
Study is registered in ResearchMatch ![]() Sponsor Condition of Interest |
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Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence
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Women and Infants Hospital of Rhode Island
Urgency Urinary Incontinence
The goal of this clinical trial is to compare treatment outcomes between an oral
medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency
urinary incontinence (UUI).
Participants will be randomly selected to receive one of the two treatments. The primary
outcome measure1 expand
The goal of this clinical trial is to compare treatment outcomes between an oral medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency urinary incontinence (UUI). Participants will be randomly selected to receive one of the two treatments. The primary outcome measure will be at 3 months, and women will be followed for a total of 12 months. Based on patient expert input, there are 2 primary outcomes: Treatment satisfaction and urinary symptom severity. Type: Interventional Start Date: Jun 2023 |
Immunization With BCG Vaccine to Prevent Tuberculosis Infection
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Henry M. Jackson Foundation for the Advancement of Military Medicine
Tuberculosis Infection
The purpose of this research is to find out if a single dose of pre-travel vaccination
with BCG can lessen tuberculosis (TB) infection by producing an immune response when
given to adults traveling to countries with a high burden of TB. BCG will be compared
with a placebo (an inactive vaccine). BCG1 expand
The purpose of this research is to find out if a single dose of pre-travel vaccination with BCG can lessen tuberculosis (TB) infection by producing an immune response when given to adults traveling to countries with a high burden of TB. BCG will be compared with a placebo (an inactive vaccine). BCG (Japan) is used globally but is not approved for use in the United States, therefore it is considered experimental. Participants choosing to take part in this research study, will be randomly assigned (this is like a coin flip) to BCG or placebo. 2000 eligible volunteers will be enrolled. Type: Interventional Start Date: Dec 2021 |
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
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Endotronix, Inc.
Heart Failure NYHA Class II
Heart Failure NYHA Class III
Heart Failure
This is a prospective, multi-center, open label, randomized control clinical trial
evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in
NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial).
The study contains of 5 arms:
NYHA II Cohort - To demonstrate s1 expand
This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial). The study contains of 5 arms: NYHA II Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients, where patients have daily access to PAP data. - Treatment Arm (Group 1) - Active Control Arm (Group 2) - Crossover Arm (Group 3) NYHA III Cohort - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class III HF patients, where patients have daily access to PAP data, including a randomized sub-study to evaluate a clinician-directed patient self-management strategy. Type: Interventional Start Date: Nov 2023 |
Leveraging Telehealth to Improve Oral Health Among Cancer Survivors
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Georgetown University
Oral Mucositis
Periodontal Diseases
Cancer
The investigators will conduct a 2-arm 6-month randomized clinical controlled trial to
evaluate the effectiveness of an oral Telehealth Intervention (THI) in preventing
cancer-related oral complications, improving oral health maintenance and oral health
related quality of life, and reducing systemi1 expand
The investigators will conduct a 2-arm 6-month randomized clinical controlled trial to evaluate the effectiveness of an oral Telehealth Intervention (THI) in preventing cancer-related oral complications, improving oral health maintenance and oral health related quality of life, and reducing systemic inflammation compared to Usual Care (UC) among unselected cancer survivors. Type: Interventional Start Date: Aug 2024 |
Older Breast Cancer Patients: Risk for Cognitive Decline
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Georgetown University
Cancer, Breast
Age-related Cognitive Decline
Cognitive Decline
The goal of this study is to evaluate the impact of systemic therapy on cognition in
older breast cancer patients, explore change in APE, LM and Cognition domains, measure
associations between cognitive decline and QOL, and describe how genetic polymorphisms,
inflammatory biomarkers, sleep and phys1 expand
The goal of this study is to evaluate the impact of systemic therapy on cognition in older breast cancer patients, explore change in APE, LM and Cognition domains, measure associations between cognitive decline and QOL, and describe how genetic polymorphisms, inflammatory biomarkers, sleep and physical measures moderate cognitive outcomes. This study is being done nationally, with recruiting sites at Georgetown University, Montgomery General Hospital, Virginia Cancer Specialists, Washington Hospital Center, Reston Breast Care Specialists, Memorial Sloan-Kettering, Moffitt Cancer Center, City of Hope National Medical Center, Hackensack University Medical Center, Indiana University and University of California, Los Angeles. Type: Observational Start Date: Aug 2010 |
A Study to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer's Disease
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Cognition Therapeutics
Early Alzheimer's Disease
This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed
to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to
placebo in participants diagnosed with early Alzheimer's disease. expand
This is a multicenter randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in participants diagnosed with early Alzheimer's disease. Type: Interventional Start Date: Jun 2023 |
Life's End Benefits of cannaBidiol and tetrahYdrocannabinol
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University of Southern California
Agitation
Dementia
This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral
combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over
12 weeks. This study is designed to test the hypothesis that treatment with an oral
combination of THC/CBD will reduce a1 expand
This is a multicenter randomized double-blind placebo-controlled Phase 2 study of an oral combination of tetrahydrocannabinol (THC) and cannabidiol (CBD) compared to placebo over 12 weeks. This study is designed to test the hypothesis that treatment with an oral combination of THC/CBD will reduce agitation hospice care-eligible patients with agitation and dementia as measured by the Cohen Mansfield Agitation Inventory (CMAI) when compared to placebo at 2 weeks. This study will enroll approximately 120 participants of any gender at least 40 years of age who are hospice care-eligible with agitation and dementia (HAD). Participants will be randomized (50:50) to either active study drug (T2:C100) or placebo. The double-blind period of this study is 12 weeks. A 12 week optional open-label extension will be offered to participants who complete the double-blind period. Type: Interventional Start Date: Dec 2023 |
A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis
AbbVie
Rheumatoid Arthritis
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness,
swelling and loss of joint function. This study will evaluate the efficacy and safety of
targeted therapies through a series of substudies for the treatment of moderately to
severely active Rheumatoid Arthritis (RA1 expand
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies for the treatment of moderately to severely active Rheumatoid Arthritis (RA). This study currently includes 3 substudies evaluating different treatments in participants with RA. Substudy 1 will evaluate lutikizumab monotherapy (treatment given alone) compared to placebo (looks like the study treatment but contains no medicine). Substudy 2 will evaluate ravagalimab monotherapy compared to placebo and Substudy 3 will evaluate lutikizumab and ravagalimab combination therapy (treatments given together) compared to placebo. Approximately 180 participants who have failed 1 or 2 biologic/targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapies will be enrolled in the study at approximately 65 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Jun 2025 |
The FYI on MRI: A Multilevel Decision Support Intervention for Screening Breast MRI
Georgetown University
Breast Neoplasm Female
Early Detection of Cancer
Hereditary Breast and Ovarian Cancer Syndrome
Magnetic Resonance Imaging
The purpose of this study is to test the impact of a multilevel decision support
intervention on informed decisions about breast MRI among high-risk Black and Latina
women. Participants (N=80) will be randomized to (1) enhanced usual care (risk assessment
+ referral to nurse practitioner) or (2) de1 expand
The purpose of this study is to test the impact of a multilevel decision support intervention on informed decisions about breast MRI among high-risk Black and Latina women. Participants (N=80) will be randomized to (1) enhanced usual care (risk assessment + referral to nurse practitioner) or (2) decision support (enhanced usual care + decision aid). Assessments will take place at baseline (T0) and 1-month post-intervention (T1). The primary outcome is informed decisions about breast MRI at T1. Type: Interventional Start Date: Jun 2025 |
Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis
AbbVie
Psoriatic Arthritis
Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune
system attacks healthy cells and tissues causing joint pain, stiffness, and swelling.
Symptoms can get worse and go away for periods of time. This study will evaluate the
efficacy and safety of targeted therapies t1 expand
Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies, for the treatment of active psoriatic arthritis and to assess the changes in disease symptoms. The therapies being assessed in this sub-study are risankizumab and lutikizumab. Participants will be randomized in a 1:1:1 ratio to one of the three treatment arms: lutikizumab monotherapy, risankizumab monotherapy or a combination therapy of lutikizumab and risankizumab. Around 120 participants will be enrolled in the study at approximately 40 sites worldwide. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Apr 2025 |
A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With C1
Pfizer
COVID-19 SARS-CoV-2 Infection
The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in
adults and adolescents with COVID-19 who do not need to be in the hospital but who are at
high risk for progression to severe disease. Eligible participants will be randomly
assigned (by chance) to receive ibuzatr1 expand
The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months. Type: Interventional Start Date: Dec 2024 |
A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine1
Ipsen
Episodic Migraine
Chronic Migraine
A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on
one side of the head. It is often accompanied by feeling or being sick and a sensitivity
to bright lights and sound. Migraines are caused by a series of events when the brain
gets stimulated or activated, which1 expand
A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head. It is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Migraines are caused by a series of events when the brain gets stimulated or activated, which causes the release of chemicals that cause pain. IPN10200 is a medication that stops the release of these chemical messengers. Participants with episodic migraine (EM) or chronic migraine (CM) will be included in both Step 1 and Step 2. "Headache days" are when participants experience headaches that meet the criteria for a migraine or a headache without the additional migraine-specific symptoms. "Migraine days" occur when the headache displays clear migraine characteristics. This study aims to determine: - The safety and efficacy of injecting IPN10200 directly into the muscles of the head and neck to prevent EM and CM, - The right amount (dose) of IPN10200 to inject at each point, - The total amount (dose) of IPN10200 that provides the best balance between safety and efficacy preventing migraines. Participants will need to complete a daily electronic migraine Diary (eDiary) and questionnaires throughout the study. The total study duration for a participant will be up to 44 weeks. Type: Interventional Start Date: Oct 2024 |
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
Allogene Therapeutics
Large B-cell Lymphoma
This is a randomized, open-label study in adult patients who have completed standard
first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or
partial response suitable for observation, but who have minimal residual disease (MRD) as
detected by the Foresight CLARITY™ I1 expand
This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation. In this study, participants with MRD are randomized 1:1 to treatment with cema-cel or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide. Prior to August 2025, participants may also have received an anti-CD52 monoclonal antibody, ALLO-647, as part of their lymphodepletion regimen. Type: Interventional Start Date: Jun 2024 |
Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Seconda1
OSE Immunotherapeutics
Patients With Non-Small Cell Lung Cancer
Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with
squamous and non-squamous metastatic NSCLC with ICI secondary resistance.
Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with
OSE2101 monotherapy or control Arm B SoC with doce1 expand
Multicenter, randomized (2:1), open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance. Patients will be randomized into 2 arms (randomization 2:1): experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy. Stratification factors will be histology (squamous versus non squamous) and ECOG Performance Status (0 versus 1). Type: Interventional Start Date: Dec 2024 |
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Livi1
Eli Lilly and Company
Atherosclerotic Cardiovascular Disease (ASCVD)
Chronic Kidney Disease (CKD)
The main purpose of this study is to determine if retatrutide can significantly lower the
incidence of serious heart-related complications or prevent the worsening of kidney
function. The trial will enroll adults with body mass index 27 kg/m^2 or higher and
Atherosclerotic Cardiovascular Disease an1 expand
The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor. Type: Interventional Start Date: Apr 2024 |
A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multi1
Sanofi
Relapsing Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Progressive Relapsing Multiple Sclerosis
This is a Phase 3 extension, global, multicenter study to assess the long-term safety and
tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or
NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3
tolebrutinib pivotal trials (GEMI1 expand
This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 [EFC16033], GEMINI 2 [EFC16034], HERCULES [EFC16645], or PERSEUS [EFC16035]). SUBSTUDY: ToleDYNAMIC substudy Type: Interventional Start Date: Apr 2024 |
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
Seagen, a wholly owned subsidiary of Pfizer
Breast Neoplasms
Gastroesophageal Junction Adenocarcinoma
HER2 Low Breast Neoplasms
HER2 Positive Breast Neoplasms
Stomach Neoplasms
This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in
part of your body like your lungs or liver instead of your blood. Once they've grown
bigger in one spot or spread to other parts of the body, they're harder to treat. This is
called advanced or metastatic cance1 expand
This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood. Once they've grown bigger in one spot or spread to other parts of the body, they're harder to treat. This is called advanced or metastatic cancer. Participants in this study must have breast cancer or gastric cancer. Participants must have tumors that have HER2 on them. This allows the cancer to grow more quickly or spread faster. There are few treatment options for patients with advanced or metastatic solid tumors that express HER2. This clinical trial uses an experimental drug called disitamab vedotin (DV). Disitamab vedotin is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial uses a drug called tucatinib, which has been approved to treat cancer in the United States and some other countries. This drug is sold under the brand name TUKYSA®. This study will test how safe and how well DV with tucatinib works for participants with solid tumors. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease. Type: Interventional Start Date: May 2024 |
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 In1
Hoffmann-La Roche
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
This is a Phase III, randomized, open-label multicenter study that will evaluate the
efficacy and safety of giredestrant compared with fulvestrant, both in combination with
the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib),
in participants with estrogen recept1 expand
This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy. Type: Interventional Start Date: Dec 2023 |
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Gilead Sciences
Primary Biliary Cholangitis
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary
Biliary Cholangitis (PBC) and Compensated Cirrhosis. expand
To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis. Type: Interventional Start Date: Sep 2023 |
A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Comb1
BeiGene
Waldenstrom Macroglobulinemia
Waldenstrom's Macroglobulinemia Recurrent
Waldenstrom's Macroglobulinemia Refractory
This study will evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax
(BGB-11417) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R
WM) and in combination with zanubrutinib in adult participants with previously untreated
WM. expand
This study will evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax (BGB-11417) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult participants with previously untreated WM. Type: Interventional Start Date: Sep 2023 |
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fib1
United Therapeutics
Progressive Pulmonary Fibrosis
Interstitial Lung Disease
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil
in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. expand
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period. Type: Interventional Start Date: Oct 2023 |
Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine The1
NRG Oncology
Breast Cancer
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian
function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in
improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage
breast cancer (EBC) patients with es1 expand
This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients). Type: Interventional Start Date: Aug 2023 |
Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Com1
Alliance for Clinical Trials in Oncology
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Early Stage Triple-Negative Breast Carcinoma
The phase III trial compares the effect of pembrolizumab to observation for the treatment
of patients with early-stage triple-negative breast cancer who achieved a pathologic
complete response after preoperative chemotherapy in combination with pembrolizumab.
Immunotherapy with monoclonal antibodie1 expand
The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab. Type: Interventional Start Date: Jun 2023 |
A Trial That Evaluates Disease Characteristics in Hemophilia B Adult Male Participants Receiving Pr1
Regeneron Pharmaceuticals
Hemophilia B
This study is focused on males who have Hemophilia B and who need regular preventive
treatment with factor IX protein (FIX) replacement therapy to prevent and also to control
their bleeding events. The aim of the study is to gather at least 6 months of information
on bleeding events for each indivi1 expand
This study is focused on males who have Hemophilia B and who need regular preventive treatment with factor IX protein (FIX) replacement therapy to prevent and also to control their bleeding events. The aim of the study is to gather at least 6 months of information on bleeding events for each individual participant while they continue to use their usual FIX replacement therapy. There is no experimental treatment being tested in this study. The study is informational, and part of a larger program to understand and treat Hemophilia B with a potential experimental new therapy in the future. There is no obligation to agree to taking part in this future study. The study is looking to answer several other research questions to help understand each participant's individual disease characteristics, including: - How often to use FIX replacement therapy, both on a regular basis (prophylaxis) and as needed to treat bleeding events - Measurement of FIX activity (factor IX is a clotting factor) by different laboratories using different types of tests in Hemophilia B participants - Possible complications from the FIX replacement therapy the patient receives (usual standard of care will continue to be used) - How quality of life is affected by Hemophilia B - How joint health is affected by Hemophilia B - How often the participant visits the emergency room, urgent care center, physician's office, hospital, or has a telemedicine visit as a result of bleeding events - Whether the body makes antibodies (a protein produced by the body's immune system) against the FIX replacement therapy you receive, which could make the drug less effective or could lead to side effects Type: Observational Start Date: Jan 2024 |
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in1
Hoffmann-La Roche
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
The main objective of this study is to evaluate the efficacy of satralizumab compared
with placebo based on time from randomization to the first occurrence of an adjudicated
MOGAD relapse in the double-blind (DB) treatment period. Participants who experience an
adjudicated relapse or complete the D1 expand
The main objective of this study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period. Participants who experience an adjudicated relapse or complete the DB period can enter open-label extension (OLE) period. After the primary clinical cutoff date (CCOD), additional adolescent participants may be enrolled directly into the OLE period. Type: Interventional Start Date: Aug 2022 |