Actively Recruiting
A Phase III Multicenter Randomized Controlled Open-label Trial Assessing Libevitug Injection in Chronic Hepatitis Delta Virus Infection
Led by Huahui Health · Updated on 2026-05-15
160
Participants Needed
1
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of libevitug, an intravenous drug, in participants with chronic Hepatitis Delta Virus (HDV) infection. This international, multicenter, randomized, controlled, open-label Phase III trial aims to compare different doses of libevitug and a control group to understand its impact on viral levels and liver function. The study includes participants aged 12 to 70 years with chronic HDV infection lasting at least six months. Participants will be randomly assigned to one of three groups: a group receiving libevitug 20 mg/kg every two weeks for 96 weeks, a group receiving libevitug 10 mg/kg every two weeks for 96 weeks, or a control group observed for 48 weeks before starting libevitug 20 mg/kg every two weeks for the remaining 48 weeks. Treatment is administered by intravenous infusion. The control group allows comparison of immediate versus delayed treatment effects. During the study, participants will undergo regular assessments including blood tests to measure HDV RNA levels and liver enzyme (ALT) normalization. Liver stiffness and liver function scores will also be monitored up to 96 weeks, with clinical events and safety data collected through week 120. The primary outcome is the proportion of participants achieving significant reduction or undetectable HDV RNA and ALT normalization at Week 48. Participants can expect to attend frequent study visits for these evaluations throughout the study period.
CONDITIONS
Brief Title
A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign written informed consent
- Male or female participants aged 12 to 70 years
- Chronic HDV infection for at least 6 months
- For those needing anti-HBV therapy, first-line treatment should start at least 12 weeks before study treatment or be willing to initiate it
- HBV DNA suppressed
- HDV RNA level of 500 IU/mL or higher at screening
- ALT levels greater than 1 times but less than 10 times the upper limit of normal at screening
- Able to communicate well and comply with study protocol
You will not qualify if you...
- Decompensated cirrhosis
- Previous or current hepatocellular carcinoma (HCC) or suspicion of HCC
- History of alcoholic liver disease, nonalcoholic steatohepatitis, autoimmune liver disease, hereditary liver diseases, drug-induced liver disease, or other significant chronic liver diseases not caused by HDV/HBV
- Active hepatitis C infection or HIV infection
- History of malignancies other than HCC
- Clinically significant ECG abnormalities deemed unsuitable by investigator
- Alcohol abuse or drug addiction within the past year
- Participation in any drug or medical device clinical trial within 1 month before randomization
- Pregnancy, lactation, or positive pregnancy test in women of childbearing potential
- Any other clinically significant abnormal lab results, severe acute or chronic medical or psychiatric conditions, or serious systemic diseases
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 96 weeks
Participants receive Libevitug through intravenous infusion every 2 weeks as part of their assigned dose for up to 96 weeks. The control group is observed for 48 weeks before starting treatment.
Biweekly visits for infusion over the treatment period
Duration - Up to 24 weeks after treatment
Participants are monitored for safety and liver-related clinical events after completing treatment.
Visits periodically up to week 120
Trial Site Locations
Total: 1 location
1
The First Hospital of Jilin University
Changchun, Jilin, China, 130033
Actively Recruiting
Research Team
J
Jiaying Wen PM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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