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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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Bulevirtide, a treatment for Chronic Hepatitis Delta (CHD), functions by inhibiting the entry of the Hepatitis Delta Virus (HDV) into liver cells through blocking the NTCP receptor. This mechanism is significant for CHD patients as it prevents the virus from entering and replicating within liver cells, thereby reducing viral load and slowing liver disease progression.
Other treatments for CHD generally aim to reduce viral replication or boost the immune response to control the infection and mitigate liver damage.
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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
1,085 Previous Clinical Trials
848,244 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.
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