BridgeMD
Observational Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Patients with Chronic hepatitis D
EU CTIS ID: 2023-504414-29-00
What this study is testing
To assess the percentage of patients with virological response of HDV RNA < limit of detection (LoD) at follow-up (FU) 12 months after end of treatment (EOT).
- Phase III and phase IV (Integrated)
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
- Age > 18 years
- Diagnosis of chronic HBV/HDV co-infection
- Have compensated liver disease (presence of portal hypertension without ongoing hepatic decompensation, as ascites, variceal bleeding and hepatic encephalopathy, is allowed)
- Have indication for treatment of BLV, or already treated with BLV.
- For female participants: a. Postmenopausal for at least one year, or b. Surgically sterile (total hysterectomy or bilateral oophorectomy, bilateral tubal ligation, staples, or another type of sterilization), or c. Abstinence from heterosexual intercourse throughout the treatment period, or d. Willingness to use highly effective contraception (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive) throughout the treatment period and for 6 months after last dose of the drugs in the study.
- Male participants must agree to use a highly effective contraception (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive used by female partners) throughout the treatment period and for 6 months after the last dose of the drugs in the study.
You likely can't join if
- Any contra-indications to treatment with BLV, including any intolerance or hypersensitivity to the active ingredient or other components of BLV.
- Pregnant or breast-feeding women
- Patients with predictable difficulties of FU according to the investigator
- Any other condition that, in the opinion of Investigator, precludes the patient from taking part in this study.
See the full eligibility criteria
- Age > 18 years
- Diagnosis of chronic HBV/HDV co-infection
- Have compensated liver disease (presence of portal hypertension without ongoing hepatic decompensation, as ascites, variceal bleeding and hepatic encephalopathy, is allowed)
- Have indication for treatment of BLV, or already treated with BLV.
- For female participants: a. Postmenopausal for at least one year, or b. Surgically sterile (total hysterectomy or bilateral oophorectomy, bilateral tubal ligation, staples, or another type of sterilization), or c. Abstinence from heterosexual intercourse throughout the treatment period, or d. Willingness to use highly effective contraception (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive) throughout the treatment period and for 6 months after last dose of the drugs in the study.
- Male participants must agree to use a highly effective contraception (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive used by female partners) throughout the treatment period and for 6 months after the last dose of the drugs in the study.
- Participants who are willing to give written informed consent.
- Any contra-indications to treatment with BLV, including any intolerance or hypersensitivity to the active ingredient or other components of BLV.
- Pregnant or breast-feeding women
- Patients with predictable difficulties of FU according to the investigator
- Any other condition that, in the opinion of Investigator, precludes the patient from taking part in this study.
The study team makes the final eligibility decision.
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, 65+ years. The study team makes the final eligibility decision.
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.