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Virus Therapy
Bulevirtide for Hepatitis D
Phase 3
Waitlist Available
Led By Pavel Bogomolov, MD
Research Sponsored by MYR GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delayed treatment arm: week 48 up to week 96; bulevertide 2mg/day and 10 mg/day arms: first dose date up to week 96
Awards & highlights
Study Summary
This trial will compare the effectiveness of bulevirtide to no treatment in people with CHD.
Who is the study for?
This trial is for adults with chronic hepatitis delta (CHD) who have detectable HDV RNA, moderately elevated liver enzymes, and normal serum albumin levels. Women must not be pregnant and should use effective contraception or be postmenopausal/surgically sterile. Participants cannot join if they have severe kidney issues, certain heart conditions, uncontrolled hypertension, mental disorders affecting protocol adherence, recent serious liver disease events, low blood counts, recent interferon treatment or organ transplants.Check my eligibility
What is being tested?
The study tests the effectiveness of bulevirtide in treating CHD compared to a delayed treatment approach. It aims to see how well bulevirtide works over time by monitoring participants' health status before starting them on the drug.See study design
What are the potential side effects?
While specific side effects are not listed here for bulevirtide in this summary context; generally speaking treatments like antiviral drugs can cause headaches, fatigue, nausea and potential injection site reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ delayed treatment arm: week 48 up to week 96; bulevertide 2mg/day and 10 mg/day arms: first dose date up to week 96
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~delayed treatment arm: week 48 up to week 96; bulevertide 2mg/day and 10 mg/day arms: first dose date up to week 96
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Combined Response at Week 48
Secondary outcome measures
Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 144
Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 192
Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 48
+9 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Delayed TreatmentExperimental Treatment1 Intervention
Participants will receive delayed treatment with bulevirtide 10 mg/day subcutaneously (SC) for 96 weeks after an observational period of 48 weeks.
Group II: Bulevirtide 2 mg/dayExperimental Treatment1 Intervention
Participants will receive bulevirtide 2 mg/day SC for 144 weeks.
Group III: Bulevirtide 10 mg/dayExperimental Treatment1 Intervention
Participants will receive bulevirtide 10 mg/day SC for 144 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bulevirtide
2019
Completed Phase 2
~230
Find a Location
Who is running the clinical trial?
MYR GmbHLead Sponsor
1 Previous Clinical Trials
175 Total Patients Enrolled
1 Trials studying Chronic Hepatitis Delta
175 Patients Enrolled for Chronic Hepatitis Delta
Gilead SciencesLead Sponsor
1,082 Previous Clinical Trials
842,691 Total Patients Enrolled
1 Trials studying Chronic Hepatitis Delta
175 Patients Enrolled for Chronic Hepatitis Delta
Gilead Medical MonitorStudy ChairGilead Sciences
1 Previous Clinical Trials
175 Total Patients Enrolled
1 Trials studying Chronic Hepatitis Delta
175 Patients Enrolled for Chronic Hepatitis Delta
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't used interferons in the last 6 months.The individual's serum or plasma screened positive for hepatitis D virus RNA.I am postmenopausal, surgically sterile, abstinent, or willing to use effective contraception.Participants in this study must agree to use a highly effective contraception method (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive used by female partners) and not to donate sperm throughout the study and for 3 months after the last dose of study medication, regardless of whether they discontinue the study medication during the treatment period.The individual has tested positive for serum anti-hepatitis delta virus (HDV) antibody or for serum/ plasma HDV ribonucleic acid (RNA) for at least 6 months before screening.The study team will provide a signed and dated informed consent form for the participant to read and sign.Alanine transaminase level between 1 and 10 times the upper limit of normal.My liver is not working well, but I don't have severe complications.I have Hepatitis C or uncontrolled HIV.I can follow all study requirements and undergo necessary procedures.I have had severe liver problems in the last 2 years.I am not using any disallowed mental health medications.I regularly use medication that affects my immune system.I have tested positive for hepatitis delta for at least 6 months.I am postmenopausal, surgically sterile, abstinent, or willing to use effective birth control.I have a systemic connective tissue disorder.I have severe heart failure.My high blood pressure is not under control.I have a liver condition not caused by hepatitis B.I have had a solid organ transplant.I have taken bulevirtide before.My kidney function, measured by creatinine clearance, is below 60 mL/min.I have or might have cancer, or had it, or a pre-cancer condition in the last 5 years.The person has a serum albumin level of more than 28 grams per liter.There is no evidence of pregnancy in the female patient.
Research Study Groups:
This trial has the following groups:- Group 1: Delayed Treatment
- Group 2: Bulevirtide 2 mg/day
- Group 3: Bulevirtide 10 mg/day
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial open to people who are not yet senior citizens?
"The age range that this clinical trial is willing to accept patients is anyone who is over 18 and younger than 65."
Answered by AI
Is Bulevirtide a common drug in research?
"To date, there is one ongoing clinical trial evaluating the efficacy of Bulevirtide. This specific study is in Phase 3 and based out of Moscow. There are a total of 19 research sites running trials for this medication, with additional locations in New york."
Answered by AI
Have medical researchers looked into this before?
"To date, there is only one ongoing study for Bulevirtide taking place in 1 city across 5 countries. The first clinical trial for this medication was run in 2019 by MYR GmbH. That year, 150 patients completed Phase 3 of the drug approval process. In the 2 years since then, 5 more trials have been completed."
Answered by AI
What is the target number of participants for this research project?
"No, this study has completed recruitment. The trial was posted on 4/17/2019 and updated for the last time on 10/3/2022. If you are looking for other studies, 272 trials for patients with hepatitis d, chronic and 1 trial for Bulevirtide are still actively recruiting participants."
Answered by AI
Is Bulevirtide an FDA-regulated medication?
"Bulevirtide's safety is estimated to be a 3. This assessment is based on the fact that Bulevirtide is in Phase 3 trials, meaning there is both some efficacy data as well as multiple rounds of safety data available."
Answered by AI
Are there any current openings for participants in this clinical trial?
"The clinicaltrials.gov website reveals that this trial is not enrolling patients at the moment, though it did originally open recruitment on April 17th, 2019. The most recent update to the study was on October 3rd, 2020. There are 273 other trials with open enrollment currently."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Universitätsklinikum Frankfurt Medizinische Klinik 1
Universitätsklinikum Hamburg-Eppendorf
U.O. Epatologia - Azienda Ospedaliero Universitaria Pisana
Other
What portion of applicants met pre-screening criteria?
Met criteria
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