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

Phase 3RecruitingNCT07499544

Huahui Health160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Chronic Hepatitis D Infection

Interventions

Libevitug 20 mg/kgDRUG

Route of administration: intravenous infusion

Libevitug 10 mg/kgDRUG

Route of administration: intravenous infusion

Delayed treatment with libevitugOTHER

Route of administration: intravenous infusion

Eligibility

Sex: ALLMin age: 12 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

The First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

Outcomes

Primary Outcomes

Proportion of participants with HDV RNA below LLOQ with TND or a decrease of ≥ 2 log10 from baseline, and ALT normalization at Week 48 of the treatment period

Proportion of participants with HDV RNA below Lower Limit of Quantification (LLOQ) with target not detected (TND) or a decrease of ≥ 2 log10 from baseline, and ALT normalization at Week 48 of the treatment period

Time frame: Week 48

Secondary Outcomes

Proportion of participants with HDV RNA below LLOQ or a decrease of ≥ 2 log10 from baseline, and ALT normalization

Time frame: up to week 96

Proportion of participants with HDV RNA below LLOQ or a decrease of ≥ 2 log10 from baseline

Time frame: up to week 96

Proportion of participants with plasma HDV RNA achieving HDV RNA < LLOQ

Time frame: up to week 96

Proportion of participants with ALT normalization

Time frame: up to week 96

Change from baseline in liver stiffness measurement (LSM)

Time frame: up to week 96

Change from baseline in plasma HDV RNA levels at different time points

Time frame: up to week 96

Change from baseline in Model for End-Stage Liver Disease (MELD) score at different time points

Time frame: up to week 96

Change from baseline in Child-Pugh score at different time points during the treatment period, extended treatment period and follow-up period. (A higher Child-Pugh score indicates poorer liver function, more severe disease, and a worse prognosis)

Central Contacts

Jiaying Wen PM

CONTACT

+86 13552466248 wenjiaying@hhhbio.com

Data from ClinicalTrials.gov

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