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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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
Are there results?
None posted in the registry

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 ;
Show all 17Show fewer
  • 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

Other trials in China

Pakistan2 sites

  • Site 201

    Karachi, Karachi

  • Site 202

    Karachi, Karachi

Other trials in Pakistan

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.

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 groups in NCT05861674
Study groupRoleWhat they receive
HH-003 (20mg/kg)+TAFExperimentalSubjects 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)+TAFExperimentalSubjects 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
TAFOtherSubjects 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.

  1. 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)

  1. 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

  2. Proportion of subjects with ALT normalization

    Measured: At Week 24 of the treatment period

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

    Measured: At Week 24 of the treatment period

  4. 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

  5. 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

  6. Proportion of subjects with ALT normalization

    Measured: At Week 48 of the treatment period

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

    Measured: At Week 48 of the treatment period

  8. 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

  9. Proportion of subjects with ALT normalization

    Measured: At Week 24 of the follow-up period

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

    Measured: At Week 24 of the follow-up period

  11. Change from baseline in serum HDV RNA levels at different time points

    Measured: Up to Week 72

  12. 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.

  1. First posted17 May 2023
  2. Study start16 Jun 2023
  3. Primary completion18 Jul 2024
  4. Study completion21 Jun 2025

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

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 7 inclusion and 17 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: finished, as of the sponsor's last update on 22 Oct 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: At Week 24 of the treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05861674.

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 22 Oct 2026.

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