Chronic Hepatitis B and Hepatitis D Co-infectionPhase 2NCT05674448
A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and Hepatitis D Co-infection
A Phase 2 study testing HH-003 20mg/kg and HH-003 3mg/kg in people with Chronic Hepatitis B and Hepatitis D Co-infection, run by Huahui Health at 1 site in China.
Trial summary
This is an open-label phase IIa study of HH-003 to evaluate its antiviral activity and safety in subjects with chronic hepatitis B and hepatitis D co-infection. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis B and Hepatitis D Co-infection
- What is being tested?
- HH-003 20mg/kg and HH-003 3mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2021to 4 Jan 2023
- 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 informed consent form;
- Male or female subjects aged from 18 to 70 years inclusively;
- 18 kg/m2≤BMI≤32 kg/m2, body weight ≥45 kg for men and ≥40 kg for women;
- Positive HBsAg, anti-HDV IgG antibody and HDV RNA at screening;
- Women of childbearing potential or male subjects with female partners of childbearing potential should agree to use an adequate and highly effective contraceptions from screening to the end of study or until 12 weeks after last dose of the study drug (whichever is longer).
Who cannot join
- Be pregnant or lactating at screening;
- Subjects with decompensated liver cirrhosis;
- Subjects with liver dysfunction (including but not limited to ascites, hepatic encephalopathy and upper gastrointestinal bleeding) within 3 months prior to screening;
- Average daily alcohol consumption >40g for men and >20g for women or drug abuse within 6 months prior to screening;
- Subjects with other serious diseases that is inappropriate for study participation per the Investigator's or the Sponsor's discretion (including but not limited to serious cardiac or pulmonary disease, chronic or recurrent urinary disorders, uncontrolled diabetes and autoimmune diseases, epilepsy requiring treatment);
- History of hepatocellular carcinoma (HCC) or hepatocellular carcinoma suggested by liver histopathology or liver imaging;
- Interferon antiviral therapy within 1 year prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Phase IIa Study to Evaluate the Antiviral Effect and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and D Co-infection
This is an open-label phase IIa study of HH-003 to evaluate its antiviral activity and safety in subjects with chronic hepatitis B and hepatitis D co-infection. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV/HDV.
- Being tested
- HH-003 20mg/kg, HH-003 3mg/kg
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HH-003 20mg/kgBiological
HH-003 20mg/kg Q2W intravenously for 24 weeks
HH-003 3mg/kgBiological
HH-003 3mg/kg Q2W intravenously for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| HH-003 20mg/kg | Experimental | HH-003 20mg/kg, intravenously, Q2W Receives: Biological: HH-003 20mg/kg |
| HH-003 3mg/kg | Experimental | HH-003 3mg/kg, intravenously, Q2W Receives: Biological: HH-003 3mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with HBV DNA Negativation or Decrease by ≥1 log10 from Baseline at Week 24
Measured: Week 24
Percentage of Participants with HDV RNA Negativation or Decrease by ≥1 log10 from Baseline at Week 24
Measured: Week 24
Change from Baseline in Serum HBsAg Levels at Week 24
Measured: from baseline to Week 24
Secondary outcomes (6)
Percentage of participants with ALT normalization at week 24
Measured: Week 24
Changes from Baseline in Serum HBsAg Levels during the Study Period
Measured: from baseline to Week 48
Changes from Baseline in Serum HBV RNA Levels during the Study Period
Measured: from baseline to Week 48
Changes from Baseline in Serum HBV DNA Levels during the Study Period
Measured: from baseline to Week 48
Changes from Baseline in Serum HDV RNA Levels during the Study Period
Measured: from baseline to Week 48
Changes from Baseline in Serum HBeAg Levels in HBeAg-positive Subjects at Screening
Measured: from baseline to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start11 Aug 2021
- Primary completion25 Jul 2022
- Study completion4 Jan 2023
Why it stopped: During the study, the sponsor adjusted the overall clinical development strategy, decided to terminate the enrollment in advance after discussion with the lead investigator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B and Hepatitis D Co-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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT05674448
- Sponsor's protocol ID
- HH003-201
- Status last verified
- Dec 2022
- First submitted
- 30 Dec 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase IIa Study to Evaluate the Antiviral Effect and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and D Co-infection
- ClinicalTrials.gov ID
- NCT05674448
- Acronym / sponsor ID
- HH003-201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: During the study, the sponsor adjusted the overall clinical development strategy, decided to terminate the enrollment in advance after discussion with the lead investigator.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Huahui HealthIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 6 Jan 2023 (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 open-label phase IIa study of HH-003 to evaluate its antiviral activity and safety in subjects with chronic hepatitis B and hepatitis D co-infection. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV/HDV.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HH-003 20mg/kg | Experimental | Biological: HH-003 20mg/kgHH-003 20mg/kg, intravenously, Q2W |
| HH-003 3mg/kg | Experimental | Biological: HH-003 3mg/kgHH-003 3mg/kg, intravenously, Q2W |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent form;
- Male or female subjects aged from 18 to 70 years inclusively;
- 18 kg/m2≤BMI≤32 kg/m2, body weight ≥45 kg for men and ≥40 kg for women;
- Positive HBsAg, anti-HDV IgG antibody and HDV RNA at screening;
- Women of childbearing potential or male subjects with female partners of childbearing potential should agree to use an adequate and highly effective contraceptions from screening to the end of study or until 12 weeks after last dose of the study drug (whichever is longer).
Key exclusion criteria (7 listed)
- Be pregnant or lactating at screening;
- Subjects with decompensated liver cirrhosis;
- Subjects with liver dysfunction (including but not limited to ascites, hepatic encephalopathy and upper gastrointestinal bleeding) within 3 months prior to screening;
- Average daily alcohol consumption >40g for men and >20g for women or drug abuse within 6 months prior to screening;
- Subjects with other serious diseases that is inappropriate for study participation per the Investigator's or the Sponsor's discretion (including but not limited to serious cardiac or pulmonary disease, chronic or recurrent urinary disorders, uncontrolled diabetes and autoimmune diseases, epilepsy requiring treatment);
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 |
|---|---|---|
| HH-003 20mg/kgHH-003 20mg/kg Q2W intravenously for 24 weeks | Biological | HH-003 20mg/kg |
| HH-003 3mg/kgHH-003 3mg/kg Q2W intravenously for 24 weeks | Biological | HH-003 3mg/kg |
Primary outcome
Percentage of Participants with HBV DNA Negativation or Decrease by ≥1 log10 from Baseline at Week 24
Time frame: Week 24
Percentage of Participants with HDV RNA Negativation or Decrease by ≥1 log10 from Baseline at Week 24
Time frame: Week 24
Change from Baseline in Serum HBsAg Levels at Week 24
Time frame: from baseline to Week 24
6 secondary outcomes
Percentage of participants with ALT normalization at week 24
Time frame: Week 24
Changes from Baseline in Serum HBsAg Levels during the Study Period
Time frame: from baseline to Week 48
Changes from Baseline in Serum HBV RNA Levels during the Study Period
Time frame: from baseline to Week 48
Changes from Baseline in Serum HBV DNA Levels during the Study Period
Time frame: from baseline to Week 48
Changes from Baseline in Serum HDV RNA Levels during the Study Period
Time frame: from baseline to Week 48
Changes from Baseline in Serum HBeAg Levels in HBeAg-positive Subjects at Screening
Time frame: from baseline to Week 48
Results and safety
The study was stopped early (reason given: During the study, the sponsor adjusted the overall clinical development strategy, decided to terminate the enrollment in advance after discussion with the lead investigator.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HH-003 20mg/kg and HH-003 3mg/kg in people with Chronic Hepatitis B and Hepatitis D Co-infection, run by Huahui Health at 1 site in China.
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: stopped early, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 was stopped early (reason given: During the study, the sponsor adjusted the overall clinical development strategy, decided to terminate the enrollment in advance after discussion with the lead investigator.). Results are not available in the source record.
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?
Percentage of Participants with HBV DNA Negativation or Decrease by ≥1 log10 from Baseline at Week 24 (time frame: Week 24). The study lists 3 primary outcomes in all. 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 10 Oct 2023.