A Phase II Study of Hepalatide in Subjects With Chronic Hepatitis B
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ClinicalTrials.gov Identifier: NCT04426968 |
Recruitment Status :
Recruiting
First Posted : June 11, 2020
Last Update Posted : December 13, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis B, Chronic | Drug: Hepalatide 2.1mg Drug: Hepalatide 4.2mg Drug: Hepalatide 6.3mg Drug: placebo 2.1mg Drug: placebo 4.2mg Drug: placebo 6.3mg Drug: Pegylated Interferon | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 96 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase II Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-effect Relationship Study of Hepalatide for Injection Combined With Pegylated Interferon in Subjects With Chronic Hepatitis B |
Actual Study Start Date : | June 18, 2021 |
Estimated Primary Completion Date : | May 2023 |
Estimated Study Completion Date : | October 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Hepalatide 2.1mg+Pegylated Interferon |
Drug: Hepalatide 2.1mg
2.1 mg/day subcutaneously (s.c.) for 24 week Drug: Pegylated Interferon 180 ug/week subcutaneously (s.c.) for 28 week |
Experimental: Hepalatide 4.2mg+Pegylated Interferon |
Drug: Hepalatide 4.2mg
4.2mg/day subcutaneously (s.c.) for 24 week Drug: Pegylated Interferon 180 ug/week subcutaneously (s.c.) for 28 week |
Experimental: Hepalatide 6.3mg+Pegylated Interferon |
Drug: Hepalatide 6.3mg
6.3mg/day subcutaneously (s.c.) for 24 week Drug: Pegylated Interferon 180 ug/week subcutaneously (s.c.) for 28 week |
Active Comparator: placebo+Pegylated Interferon |
Drug: placebo 2.1mg
2.1 mg/day subcutaneously (s.c.) for 24 week Drug: placebo 4.2mg 4.2 mg/day subcutaneously (s.c.) for 24 week Drug: placebo 6.3mg 6.3 mg/day subcutaneously (s.c.) for 24 week Drug: Pegylated Interferon 180 ug/week subcutaneously (s.c.) for 28 week |
- initial virological response [ Time Frame: 24weeks ]HBV DNA<20 IU/ml
- HBV DNA down from baseline [ Time Frame: 24weeks ]HBV DNA down from baseline log10
- Virological suppression [ Time Frame: 24weeks ]HBV DNA <2,000 IU/ml
- No response [ Time Frame: 24weeks ]HBsAg >20,000 IU/ml and HBV DNA lower than baseline <2log10 IU/ml
- Partial virological response [ Time Frame: 24weeks ]HBV DNA >20 IU/ml and ≥2log10 IU/ml lower than baseline
- HBsAg is down from baseline [ Time Frame: 24weeks ]HBsAg is down from baseline log10
- HBeAg turned negative [ Time Frame: 24weeks ]HBeAg <0.05 index
- HBeAg is down from baseline [ Time Frame: 24weeks ]HBeAg is down from baseline log10
- ALT recurrence [ Time Frame: 24weeks ]ALT≤1.25×ULN
- Histological response [ Time Frame: 24weeks ]Liver tissue inflammatory necrosis score reduced by ≥2 points with no increased liver fibrosis score; liver fibrosis score reduced by ≥1 point

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age from 18 to 60 years inclusively at the time of signing Informed Consent Form.
- HBsAg or/and HBV DNA Positive for at least 6 months before Screening.
- Subjects did not receive interferon treatment and did not receive nucleotide/nucleoside analogue within 6 months
- HBeAg positive or negative
- HBV DNA≥20,000 IU/ml (HBeAg positive) or HBV DNA≥2,000 IU/ml (HBeAg negative)
- 2×ULN ≤ALT≤10×ULN
- Serum total bilirubin<2×ULN
- Subjects had no history of decompensated liver disease(Ascites, jaundice, hepatic encephalopathy, varicose hemorrhage), serious heart disease (including unstable or uncontrolled heart disease within 6 months),serious mental illness (especially depression),organ transplantation .subjects have no uncontrolled epilepsy, mental illness, diabetes and hypertension,no autoimmune disease, immune related extrahepatic manifestations (vasculitis, purpura, nodular arteritis, peripheral neuropathy and glomerulonephritis), thyroid disease, malignant tumor, immunosuppressive therapy; no basic diseases and other serious diseases such as serious infection, retinal disease, heart failure and chronic obstructive pulmonary disease; no alcohol and drug abuse.
- Subjects must agree to use a highly effective contraception for 2 years , female subjects are not pregnant or breastfeeding
- Subjects did not donate blood or as clinical trial subjects within 3 months before screening
- Subjects have good compliance with the protocol
- Subjects understood and agreed to sign the informed consent form.
Exclusion Criteria:
- Decompensated liver disease: direct bilirubin > 1.2 × ULN,
- Prothrombin time > 1.2 × ULN, serum albumin < 35 g / L
- Severe liver fibrosis or cirrhosis: METAVIR score of liver biopsy is 4 points; or or Child-Pugh score> 7
- Hemocytopenia: neutrophil < 1 × 10^9 / L, platelet < 50 × 10^9 / L, hemoglobin < 100g / L (female) or hemoglobin < 110g / L (male) points
- HAV,HCV,HDV,HEV or HIV infection
- Pegylated interferon therapy is contraindicated
- Allergic to interferon, Such as severe depression, epilepsy, autoimmune diseases, uncontrolled thyroid dysfunction and so on
- severe retinopathy or eye disease(Eye diseases due to high blood pressure or diabetes, CMV retinitis, macular degeneration)
- Positive for anti-HBV Pre-S1 antibody.
- Hamilton Depression Scale (HAMD, 17 items) score > 17 points
- Female subjects pregnancy test positive
- Other laboratories or auxiliary examinations are obviously abnormal

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04426968
Contact: Xiaolu Tang | 86-21-68412368 ext 619 | tangxiaolu@heppharma.com | |
Contact: Xian Gao | 86-21-68412368 ext 620 | gaoxian@heppharma.com |
China, Beijing | |
The fifth medical center of PLA | Recruiting |
Beijing, Beijing, China, 100039 | |
Contact: Feng Yu 010-66933460 | |
Principal Investigator: Fusheng Wang | |
China | |
Jilin Hepatobiliary Disease Hospital | Recruiting |
Changchun, China | |
Contact: Hui Chen | |
Principal Investigator: Hui Chen | |
The first hospital of Jilin University | Recruiting |
Changchun, China | |
Contact: Qinglong Jin | |
Principal Investigator: Qinglong Jin | |
Chizhou People's Hospital | Recruiting |
Chizhou, China | |
Contact: Xiaoling Liu | |
Principal Investigator: Xiaoling Liu | |
The First Hospital Affiliated to the Army Medical University | Recruiting |
Chongqing, China | |
Contact: Qing Mao | |
Principal Investigator: Qing Mao | |
The First Affiliated Hospital of Nanchang University | Recruiting |
Nanchang, China | |
Contact: Xiaoping Wu | |
Principal Investigator: Xiaoping Wu | |
The Second Hospital of Nanjing | Recruiting |
Nanjing, China | |
Contact: Wei Ye | |
Sub-Investigator: Wei Ye | |
Qingyuan People's Hospital | Recruiting |
Qingyuan, China | |
Contact: Bei Zhong | |
Principal Investigator: Bei Zhong | |
Shanghai Tongren Hospital | Recruiting |
Shanghai, China | |
Contact: Qin Zhang | |
Principal Investigator: Qin Zhang | |
The Sixth People's Hospital of Shenyang | Recruiting |
Shenyang, China | |
Contact: Chengxin Meng | |
Principal Investigator: Chengxin Meng | |
Henan Provincial People's Hospital | Recruiting |
Zhengzhou, China | |
Contact: Jia Shang | |
Principal Investigator: Jia Shang | |
Henan Provincial Infectious Disease Hospital | Recruiting |
Zhenzhou, China | |
Contact: Guangmin Li | |
Principal Investigator: Guangmin Li |
Principal Investigator: | Fusheng Wang | The fifth medical center of PLA |
Responsible Party: | Shanghai HEP Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT04426968 |
Other Study ID Numbers: |
L47-HB-II-02 |
First Posted: | June 11, 2020 Key Record Dates |
Last Update Posted: | December 13, 2022 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Blood-Borne Infections Communicable Diseases Hepadnaviridae Infections DNA Virus Infections Hepatitis, Chronic Interferons Antineoplastic Agents Antiviral Agents Anti-Infective Agents |