Chronic Hepatitis D InfectionPhase 3NCT07499544
A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study)
A Phase 3 study testing Libevitug 20 mg/kg, Libevitug 10 mg/kg and Delayed treatment with libevitug in people with Chronic Hepatitis D Infection, run by Huahui Health at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Chronic Hepatitis D Infection
- What is being tested?
- Libevitug 20 mg/kg, Libevitug 10 mg/kg and Delayed treatment with libevitug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 22 Apr 2026to 29 Jan 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
China3 sites, 3 recruiting
- Recruiting
Site 101
Changchun, Jilin, 130033
- Recruiting
Site 104
Kashgar, Xinjiang Uygur Autonomous Region, 844000
- Recruiting
Site 103
Ürümqi, Xinjiang Uygur Autonomous Region, 830000
Pakistan3 sites, 3 recruiting
- Recruiting
Site 301
Karachi, Sindh, 74800
- Recruiting
Site 302
Karachi, Sindh, 75600
- Recruiting
Site 303
Rawalpindi, Punjab Province
United States1 site, 1 recruiting
- Recruiting
Site 201
Garden Grove, California, 92844
About this study
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)
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.
- Conditions
- Chronic Hepatitis D Infection
- Being tested
- Libevitug 20 mg/kg, Libevitug 10 mg/kg, Delayed treatment with libevitug
- Keywords
- Hepatitis Delta Virus (HDV), Viral hepatitis
- Medical subject headings
- Hepatitis D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Libevitug 20 mg/kg | Experimental | Participants will receive libevitug at a dose of 20 mg/kg Q2W via intravenous infusion for 96 weeks Receives: Drug: Libevitug 20 mg/kg |
| Libevitug 10 mg/kg | Experimental | Participants will receive libevitug at a dose of 10 mg/kg Q2W via intravenous infusion for 96 weeks Receives: Drug: Libevitug 10 mg/kg |
| Control group/delayed treatment with libevitug 20 mg/kg | Active comparator | Participants will be observed as comparator for 48 weeks, then to receive libevitug 20 mg/kg for 48 weeks Receives: Other: Delayed treatment with libevitug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 48
Secondary outcomes (11)
Proportion of participants with HDV RNA below LLOQ or a decrease of ≥ 2 log10 from baseline, and ALT normalization
Measured: up to week 96
Proportion of participants with HDV RNA below LLOQ or a decrease of ≥ 2 log10 from baseline
Measured: up to week 96
Proportion of participants with plasma HDV RNA achieving HDV RNA < LLOQ
Measured: up to week 96
Proportion of participants with ALT normalization
Measured: up to week 96
Change from baseline in liver stiffness measurement (LSM)
Measured: up to week 96
Change from baseline in plasma HDV RNA levels at different time points
Measured: up to week 96
Change from baseline in Model for End-Stage Liver Disease (MELD) score at different time points
Measured: 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)
Measured: up to week 96
Liver related clinical events
Measured: up to week 120
Percentage of participants with treatment-emergent adverse events (TEAEs)
Measured: up to week 120
Ctrough,ss
Steady-state trough concentration of libevitug
Measured: up to week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start22 Apr 2026
- Primary completion12 Sep 2028 (estimated)
- Study completion29 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis D InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huahui Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499544
- Sponsor's protocol ID
- HH003-301
- Status last verified
- Jun 2026
- First submitted
- 24 Mar 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07499544
- Acronym / sponsor ID
- HH003-301
- Conditions
- Chronic Hepatitis D Infection
- Keywords
- Hepatitis Delta Virus (HDV), Viral hepatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Huahui HealthIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 12 Sep 2028 (estimated)
- Study completion
- 29 Jan 2030 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Libevitug 20 mg/kg | Experimental | Drug: Libevitug 20 mg/kgParticipants will receive libevitug at a dose of 20 mg/kg Q2W via intravenous infusion for 96 weeks |
| Libevitug 10 mg/kg | Experimental | Drug: Libevitug 10 mg/kgParticipants will receive libevitug at a dose of 10 mg/kg Q2W via intravenous infusion for 96 weeks |
| Control group/delayed treatment with libevitug 20 mg/kg | Active comparator | Other: Delayed treatment with libevitugParticipants will be observed as comparator for 48 weeks, then to receive libevitug 20 mg/kg for 48 weeks |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Libevitug 20 mg/kgRoute of administration: intravenous infusion | Drug | Libevitug 20 mg/kg |
| Libevitug 10 mg/kgRoute of administration: intravenous infusion | Drug | Libevitug 10 mg/kg |
| Delayed treatment with libevitugRoute of administration: intravenous infusion | Other | Control group/delayed treatment with libevitug 20 mg/kg |
Primary outcome
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
11 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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Libevitug 20 mg/kg, Libevitug 10 mg/kg and Delayed treatment with libevitug in people with Chronic Hepatitis D Infection, run by Huahui Health at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, Pakistan, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiaying Wen PM (+86 13552466248, wenjiaying@hhhbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.