NCT07499544 A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study)
| NCT ID | NCT07499544 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Huahui Health |
| Condition | Chronic Hepatitis D Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-04-22 |
| Primary Completion | 2028-09-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 160 participants in total. It began in 2026-04-22 with a primary completion date of 2028-09-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an international, multicenter, randomized, controlled, open-label Phase III trial. It will evaluate the efficacy and safety of libevitug in participants with chronic HDV infection.
Eligibility Criteria
Inclusion Criteria: * Willing to sign written informed consent; * Chronic HDV history with at least 6 months; * HDV RNA ≥500 IU/mL at screening; * ALT \>1ULN and \<10×ULN; * Able to communicate well and comply with protocol. Exclusion Criteria: * Concomitant decompensated cirrhosis; * Previous or current HCC or suspicion for HCC; * Participants with history of alcoholic liver disease, nonalcoholic steatohepatitis or other clinically significant chronic liver diseases not caused by HDV/HBV; * Participants with active hepatitis C infection, or HIV infection; * Alcohol abuse or drug addiction within 1 year; * Participants have participated in other clinical trial within 1 month; * Pregnant, lactating women.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07499544 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 70 Years, studying Chronic Hepatitis D Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07499544 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 160 participants.
Is NCT07499544 currently recruiting?
Yes, NCT07499544 is actively recruiting participants. Contact the research team at wenjiaying@hhhbio.com for enrollment information.
Where is the NCT07499544 trial being conducted?
This trial is being conducted at Garden Grove, United States, Changchun, China, Kashgar, China, Ürümqi, China and 3 additional locations.
Who is sponsoring the NCT07499544 clinical trial?
NCT07499544 is sponsored by Huahui Health. The trial plans to enroll 160 participants.