BridgeMD
A Study to Evaluate Investigational Therapies in Chronic Hepatitis B Virus Infection
EU CTIS ID: 2024-513176-17-00
What this study is testing
To evaluate the efficacy of the investigational regimen(s)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must meet the following inclusion criteria to be eligible for this Master Protocol. Additional clarifications and sub-protocol-specific criteria as described in respective sub-protocol(s) will be applicable: 1. Adult ≥ 18 years of age (or age of legal consent, whichever is older) 2. Chronic HBV infection defined as a positive serum HBsAg, HBV DNA, or HBeAg on 2 occasions at least 6 months apart based on previous or current laboratory documentation (any combination of these tests performed 6 months apart is acceptable) Additional characteristics of the chronic HBV infection (eg: HBeAg status, HBV DNA level, ALT level) will be required based on the patient population (Table 3) included in respective sub-protocols 3. Besides chronic infection with HBV, must be in good health, determined from medical history, and no clinically significant findings from physical examination other than those expected in persons with cirrhosis, vital signs, and laboratory values 4. Female participants must have a negative pregnancy test or confirmation of postmenopausal status. Post-menopausal status is defined as 12 months with no menses without an alternative medical cause (see Section 10.5 for additional details). Women of child-bearing potential (WOCBP) must have a negative blood pregnancy test at screening and a negative urine pregnancy test on Day 1, cannot be breast feeding, and must be willing to use highly effective methods of contraception (Section 10.5) 14 days before study intervention administration through period defined in sub-protocol. Female participants must also agree to refrain from egg donation and in vitro fertilization from the time of study intervention administration through period defined in sub-protocol 5. Male participants with female partners of child-bearing potential must agree to meet 1 of the following contraception requirements from the time of study intervention administration through period defined in sub- protocol: documentation of vasectomy or azoospermia, or male condom use plus partner use of 1 of the contraceptive options listed for contraception for WOCBP (Section 10.5). Male participants must also agree to not donate sperm from the time of first study intervention administration through period defined in sub-protocol 6. Able to understand and comply with the study requirements and able to provide written informed consent
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply. Additional exclusion criteria may be described in respective sub- protocol(s): 1. History of clinically significant liver disease from non-HBV etiology 2. History or current evidence of hepatic decompensation, including ascites, hepatic encephalopathy, and/or esophageal or gastric varices 3. History or current suspicion of malignancy diagnosed or treated within 5 years (localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening); participants under evaluation for malignancy are not eligible. 4. History of bone marrow or solid organ transplant 5. Known active infection other than chronic HBV infection or any clinically significant acute condition such as fever (> 38° C) or acute respiratory or GI illness within 7 days prior to Day 1 6. Co-infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus (HEV). Participants who are HCV antibody or HDV antibody positive, but have a documented negative HCV RNA or HDV RNA, respectively, are eligible. Participants with positive HAV immunoglobulin M (IgM) or HEV IgM but asymptomatic and with a positive HAV IgG or HEV immunoglobulin G (IgG) are eligible. 7. History or clinical evidence of alcohol or drug abuse within the 12 months before screening or a positive drug screen at screening unless it can be explained by a prescribed medication (the diagnosis and prescription must be approved by the investigator). Note: cannabis use is permitted 8. Received an investigational agent within 90 days or 5 half-lives (if known), whichever is longer, before study intervention administration or are active in the follow-up phase of another clinical study involving interventional treatment. Participants must also agree not to take part in any other interventional study at any time during their participation in this study, inclusive of the Follow-Up Period. 9. Any clinically significant medical or psychiatric condition that may interfere with study intervention, assessment, or compliance with the protocol or otherwise makes the participant unsuitable for participation in the study, as determined by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Hong Kong
- Moldova, Republic of
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Hong Kong; Moldova, Republic of; Korea, Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.