A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study)

Huahui Health

Status and phase: Not yet enrolling; Phase 3

Conditions: Chronic Hepatitis D Infection

Treatments: Other: Delayed treatment with libevitug; Drug: Libevitug 20 mg/kg; Drug: Libevitug 10 mg/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT07499544

HH003-301

Details and patient eligibility

About

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. Eligible participants will be randomized 1:1:1 to one of three groups: libevitug 20 mg/kg group , libevitug 10 mg/kg (N=50) group, or a control/delayed treatment group (N=50). The treatment groups will receive intravenous libevitug every 2 weeks for 96 weeks, while the control group will be observed for the first 48 weeks and then receive libevitug 20 mg/kg Q2W for 48 weeks starting from Week 48.

Enrollment: 160 estimated patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing to sign written informed consent;
• Male or female, aged 18-70 years; Adolescent participants with chronic HDV infection: Male or female, age ≥12 years and <18 years at the time of signing the informed consent form (ICF)/assent;
• Chronic HDV history with at least 6 months; For participants who are also recommended for anti-HBV therapy prior first-line NrtIs treatment (ETV, TDF, TAF) should be at least 12 weeks before the planned start of study treatment, or participant is willing to initiate first-line NrtIs treatment; HBV DNA suppressed;
• HDV RNA ≥500 IU/mL at screening;
• ALT >1×ULN and <10×ULN at screening;
• 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, autoimmune liver disease or other hereditary liver diseases, drug-induced liver disease or other clinically significant chronic liver diseases not caused by HDV/HBV;
• Participants with active hepatitis C infection, or HIV infection;
• History of other malignancies other than HCC;
• Clinically significant ECG abnormalities at screening, which is deemed unsuitable for enrollment per investigator's discretion;
• Alcohol abuse or drug addiction within 1 year;
• Participants who have participated in clinical trials of any drug or medical device within 1 month before randomization;
• Pregnant, lactating women, or women of childbearing potential with a positive pregnancy test;
• Any other clinically significant abnormal lab result, severe acute/chronic medical/psychiatric condition, concomitant serious systemic disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 3 patient groups

Libevitug 20 mg/kg

Experimental group

Description:

Participants will receive libevitug at a dose of 20 mg/kg Q2W via intravenous infusion for 96 weeks

Treatment:

Drug: Libevitug 20 mg/kg

Libevitug 10 mg/kg

Experimental group

Description:

Participants will receive libevitug at a dose of 10 mg/kg Q2W via intravenous infusion for 96 weeks

Treatment:

Drug: Libevitug 10 mg/kg

Control group/delayed treatment with libevitug 20 mg/kg

Active Comparator group

Description:

Participants will be observed as comparator for 48 weeks, then to receive libevitug 20 mg/kg for 48 weeks

Treatment:

Other: Delayed treatment with libevitug