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Recruiting NCT07499544

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

Phase III Interventional Chronic Hepatitis D Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Libevitug 20 mg/kg, Libevitug 10 mg/kg, Delayed treatment with libevitug.
Who it may be relevant to
Registry conditions: Chronic Hepatitis D Infection. Basic parameters: 12 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Randomized, Controlled, Open-label, Phase III Study to Assess Efficacy and Safety of Libevitug Injection in Participants With Chronic Hepatitis Delta Virus Infection (D-clear Study)

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.

Interventions

  • Drug Libevitug 20 mg/kg
    Route of administration: intravenous infusion
  • Drug Libevitug 10 mg/kg
    Route of administration: intravenous infusion
  • Other Delayed treatment with libevitug
    Route of administration: intravenous infusion

Primary outcome measures

  • 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 [Time frame: Week 48]
Secondary outcome measures (11)
  • 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) [Time frame: up to week 96]
  • Liver related clinical events [Time frame: up to week 120]
  • Percentage of participants with treatment-emergent adverse events (TEAEs) [Time frame: up to week 120]
  • Ctrough,ss [Time frame: up to week 96]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Hospital of Jilin University — Changchun

Identifiers

NCT: NCT07499544 · HH003-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗