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NCT Number: NCT07499544

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

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.

Recruiting

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Key information

Conditions

Chronic Hepatitis D Infection Digestive System Diseases Hepatitis Hepatitis D Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Hospital of Jilin University

Changchun, Jilin, 130033, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Libevitug 20 mg/kg

Drug

Route of administration: intravenous infusion

Libevitug 10 mg/kg

Drug

Route of administration: intravenous infusion

Delayed treatment with libevitug

Other

Route of administration: intravenous infusion

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. 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

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

    Time frame: up to week 96

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

    Time frame: up to week 96

  4. Proportion of participants with ALT normalization

    Time frame: up to week 96

  5. Change from baseline in liver stiffness measurement (LSM)

    Time frame: up to week 96

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

    Time frame: up to week 96

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

    Time frame: up to week 96

  8. 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

  9. Liver related clinical events

    Time frame: up to week 120

  10. Percentage of participants with treatment-emergent adverse events (TEAEs)

    Time frame: up to week 120

  11. Ctrough,ss

    Time frame: up to week 96

    Steady-state trough concentration of libevitug

Other outcomes

  1. HDV and HBV genotyping

    Time frame: baseline

  2. Change from baseline in quality of life assessed with questionnaire (Hepatitis B quality of life instrument (HBQoL) Version 1.0 and Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) version 4.0 ) at all postbaseline assessments

    Time frame: up to week 120

Study contacts

Contact information is provided by the study sponsor or research team.

Jiaying Wen PM

CONTACT

[email protected]

+86 13552466248

Sponsors and collaborators

Lead sponsor

Huahui Health

Industry

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Mar 30, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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