NCT05734807CompletedPhase 2
A Study to Evaluate the Antiviral Activity and Safety of HH-003 in Chronic Hepatitis B Subjects With Low-level Viremia
A Multicenter, Randomized, Controlled Phase IIa Study to Evaluate the Antiviral Activity and Safety of HH-003 in Nucleos(t)Ide Analogues-treated Chronic Hepatitis B Subjects With Low-Level Viremia
Source: ClinicalTrials.gov · Last updated 15 Oct 2024
Brief summary (registry, in English)
This is a multicenter, randomized, controlled Phase IIa study of HH-003 to evaluate the antiviral activity and safety in nucleos(t)ide analogues-treated chronic hepatitis B subjects with low-level viremia. 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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 74 (actual)
- First submitted
- 9 Feb 2023
- Start date
- 20 Jul 2022
- Primary completion date
- 17 Apr 2024
- Lead sponsor
- Huahui Health
- Diseases
- Hepatitis B
- NCT number
- NCT05734807
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 74
- From 20 Jul 2022 to the primary completion date, 17 Apr 2024
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of cirrhosis at any time prior to or at time of screening, or having progressive liver fibrosis at screening ;
- History or evidence of hepatocellular carcinoma at any time prior to or at time of screening;
Other illness
- History of alcoholic liver disease, moderate fatty liver, autoimmune liver disease, other hereditary liver disease, drug-induced liver disease or other clinically significant chronic liver disease induced by non-HBV infection;
Lab values
- Exclusionary laboratory results at screening: total bilirubin \>2xULN or direct bilirubin \>1.5xULN,hemoglobin \<120 g/L for males or \<110 g/L ro females,platelets count\<100,000/mm\^3 (100×10\^9/L), and absolute neutrophils count \<1,500/mm\^3 (1.5×10\^9/L).
Other
- Females who are pregnant or lactating at screening;
Who the study is looking for
- Signed informed consent form;
- Male or female aged from 18 to 60 years (inclusively);
- 18 kg/m\^2≤BMI≤30 kg/m\^2, body weight≥50 kg for men and ≥45 kg for women;
- Subjects who have chronic HBV infection greater than or equal to 6 months at screening;
- 10 IU/mL≤HBsAg≤3000 IU/mL; HBV DNA≤2000 IU/mL; ALT≤3×ULN;
- Subjects who have been on nucleoside reverse transcriptase inhibitors therapy for more than 1 year prior to screening.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing YouAn Hospital,Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Ditan Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| Mengchao Hepatobiliary Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Nanfang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Shandong Public Health Clinical Center Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The Sixth Peoples Hospital Of Zhengzhou Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.