Chronic Hepatitis Delta Virus InfectionPhase 2NCT05861674
A Study to Assess Efficacy and Safety of HH-003 Injection in Subjects With Chronic Hepatitis Delta Virus Infection
A Phase 2 study testing HH-003(20mg/kg), HH-003(10mg/kg) and TAF in people with Chronic Hepatitis Delta Virus Infection, run by Huahui Health at 7 sites in 2 countries.
Trial summary
This is a multicenter, randomized, controlled, open-label, Phase IIb study of HH-003 injection, HH-003 injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to assess efficacy and safety in subjects with chronic hepatitis delta virus infection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis Delta Virus Infection
- What is being tested?
- HH-003(20mg/kg), HH-003(10mg/kg) and TAF
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 16 Jun 2023to 21 Jun 2025
- Phase
- Phase 2
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed the informed consent form;
- Male or female aged 18 to 70 years;
- Positive HBsAg at screening;
- History of chronic HDV infection for at least 6 months prior to randomization. For subjects also recommended for anti-HBV therapy, previous first line NrtIs treatment (ETV, TDF, TAF) within at least 12 weeks prior to the planned start of study treatment or subject's willingness to take first line NrtIs treatment for at least 12 weeks prior to the planned start of study treatment is required;
- Positive HDV antibody at screening;
- HDV RNA ≥100 IU/mL at screening;
- 1×ULN<Alanine aminotransferase (ALT) <10×ULN at screening;
Who cannot join
- Subjects with known hypersensitivity to HH-003 and its components, history of severe allergic reaction to other therapeutic antibodies or severe allergic diseases;
- Subjects with contraindications for TAF;
- History of interferon therapy within 3 months before randomization;
- Any of the following lab test results at screening:
- Total bilirubin >2×ULN (except for subjects with Gilbert syndrome);
- Direct bilirubin > 1.5×ULN ;
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- Platelets<80,000/mm3 (80×109/L);
- Serum Albumin <35 g/L;
- Prothrombin time international normalized ratio (INR) >1.3;
- Hemoglobin <100 g/L;
- Absolute neutrophils<1,500/mm3 (1.5×109/L);
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2 (according to the calculation equation of CKD-MDRD);
- Concomitant decompensated cirrhosis (cirrhosis with complications of portal hypertension and/or decreased hepatic function). The diagnosis of cirrhosis is based on, but not limited to: liver imaging assessment within 6 months prior to randomization (including screening period) (e.g.: liver ultrasound) or cirrhosis indicated by histopathology of liver biopsy, or liver stiffness measurement LSM≥17 kPa at screening, refer to more serious reported findings;
- Hepatic insufficiency within 3 months prior to randomization (including but not limited to: ascites, hepatic encephalopathy, upper gastrointestinal hemorrhage);
- Previous or current hepatocellular carcinoma (HCC) or suspicion for HCC suggested by liver histopathology or liver imaging; or serum alpha-fetoprotein (AFP) ≥ 50 ng/mL at screening;
- Subjects 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;
- History of other malignancies other than HCC, unless the subject's malignancy has been in complete remission within 3 years prior to screening and does not require chemotherapy and additional medical or surgical intervention; invasive medical devices within 1 month before randomization.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
China5 sites
Site 107
Beijing, Beijing Municipality, 100015
Site 110
Beijing, Beijing Municipality, 100050
Site 101
Changchun, Jilin, 130021
Site 109
Kashgar, Xinjiang Uygur Autonomous Region, 844000
Site 108
Ürümqi, Xinjiang Uygur Autonomous Region, 830000
About this study
Official title: A Multicenter, Randomized, Controlled, Open-label Phase IIb Study to Assess Efficacy and Safety of HH-003 Injection in Subjects With Chronic Hepatitis Delta Virus Infection
This is a multicenter, randomized, controlled, open-label, Phase IIb study of HH-003 injection, HH-003 injection is a monoclonal antibody targeting Hepatitis B virus. This study aims to assess efficacy and safety in subjects with chronic hepatitis delta virus infection.
- Conditions
- Chronic Hepatitis Delta Virus Infection
- Being tested
- HH-003(20mg/kg), HH-003(10mg/kg), TAF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HH-003(20mg/kg)Biological
20 mg/kg Q2W intravenously for 48 weeks
HH-003(10mg/kg)Biological
10 mg/kg Q2W intravenously for 48 weeks
TAFDrug
TAF 25 mg QD orally during 48-week treatment period and 24-week follow-up period
| Study group | Role | What they receive |
|---|---|---|
| HH-003 (20mg/kg)+TAF | Experimental | Subjects will receive HH-003 20 mg/kg Q2W intravenously and TAF 25 mg QD orally during 48-week treatment period, and receive TAF 25 mg QD orally during 24-week follow-up period. Receives: Biological: HH-003(20mg/kg); Drug: TAF |
| HH-003 (10mg/kg)+TAF | Experimental | Subjects will receive HH-003 10 mg/kg Q2W intravenously and TAF 25 mg QD orally during 48-week treatment period, and receive TAF 25 mg QD orally during 24-week follow-up period. Receives: Biological: HH-003(10mg/kg); Drug: TAF |
| TAF | Other | Subjects will receive TAF 25 mg QD orally during 48-week treatment period and 24-week follow-up period. Receives: Drug: TAF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with serum HDV RNA below the lower limit of detection or a decrease of ≥2 log10 IU/mL from baseline and ALT normalization
Measured: At Week 24 of the treatment period
Secondary outcomes (12)
Proportion of subjects with serum HDV RNA below the lower limit of detection or a decrease of ≥2 log10 IU/mL from baseline
Measured: At Week 24 of the treatment period
Proportion of subjects with ALT normalization
Measured: At Week 24 of the treatment period
Change from baseline in liver stiffness measurement (LSM)
Measured: At Week 24 of the treatment period
Proportion of subjects with serum HDV RNA below the lower limit of detection or a decrease of ≥2 log10 IU/mL from baseline and ALT normalization
Measured: At Week 48 of the treatment period
Proportion of subjects with serum HDV RNA below the lower limit of detection or a decrease of ≥2 log10 IU/mL from baseline
Measured: At Week 48 of the treatment period
Proportion of subjects with ALT normalization
Measured: At Week 48 of the treatment period
Change from baseline in liver stiffness measurement (LSM)
Measured: At Week 48 of the treatment period
Proportion of subjects with serum HDV RNA below the lower limit of detection or a decrease of ≥2 log10 IU/mL from baseline
Measured: At Week 24 of the follow-up period
Proportion of subjects with ALT normalization
Measured: At Week 24 of the follow-up period
Change from baseline in liver stiffness measurement (LSM)
Measured: At Week 24 of the follow-up period
Change from baseline in serum HDV RNA levels at different time points
Measured: Up to Week 72
Change from baseline in serum ALT levels at different time points
Measured: Up to Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start16 Jun 2023
- Primary completion18 Jul 2024
- Study completion21 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis Delta Virus 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huahui Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861674
- Sponsor's protocol ID
- HH003-204
- Status last verified
- Mar 2026
- First submitted
- 7 May 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No