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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
Sponsor:
Information provided by (Responsible Party):
Shanghai HEP Pharmaceutical Co., Ltd.

Brief Summary:
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

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

Detailed Description:
The study is a 4-arm parallel design, randomized, double-blind, placebo-controlled, multicenter, dose-effect relationship, phase II clinical trial. The study is designed to assess efficacy and safety of 3 Doses of hepalatide in Combination with Pegylated Interferon Compared to Pegylated Interferon Alone in patients with Chronic Hepatitis B .Subjects will be randomly assigned to the 2.1mg, 4.2mg, and 6.3mg dose groups , 32 subjects in each group . The subjects in each dose group will be randomly and double-blindly administered the corresponding dose of trial drug or placebo in a ratio of 3:1. The subjects in each dose group who received placebo treatment combine as the placebo group. All subjects will receive Pegylated Interferon treatment for 28 weeks as the basic treatment,trial drug or placebo treatment for 24 weeks continuously , followed by a safety follow-up for 4 weeks.

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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




Primary Outcome Measures :
  1. initial virological response [ Time Frame: 24weeks ]
    HBV DNA<20 IU/ml


Secondary Outcome Measures :
  1. HBV DNA down from baseline [ Time Frame: 24weeks ]
    HBV DNA down from baseline log10


Other Outcome Measures:
  1. Virological suppression [ Time Frame: 24weeks ]
    HBV DNA <2,000 IU/ml

  2. No response [ Time Frame: 24weeks ]
    HBsAg >20,000 IU/ml and HBV DNA lower than baseline <2log10 IU/ml

  3. Partial virological response [ Time Frame: 24weeks ]
    HBV DNA >20 IU/ml and ≥2log10 IU/ml lower than baseline

  4. HBsAg is down from baseline [ Time Frame: 24weeks ]
    HBsAg is down from baseline log10

  5. HBeAg turned negative [ Time Frame: 24weeks ]
    HBeAg <0.05 index

  6. HBeAg is down from baseline [ Time Frame: 24weeks ]
    HBeAg is down from baseline log10

  7. ALT recurrence [ Time Frame: 24weeks ]
    ALT≤1.25×ULN

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age from 18 to 60 years inclusively at the time of signing Informed Consent Form.
  2. HBsAg or/and HBV DNA Positive for at least 6 months before Screening.
  3. Subjects did not receive interferon treatment and did not receive nucleotide/nucleoside analogue within 6 months
  4. HBeAg positive or negative
  5. HBV DNA≥20,000 IU/ml (HBeAg positive) or HBV DNA≥2,000 IU/ml (HBeAg negative)
  6. 2×ULN ≤ALT≤10×ULN
  7. Serum total bilirubin<2×ULN
  8. 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.
  9. Subjects must agree to use a highly effective contraception for 2 years , female subjects are not pregnant or breastfeeding
  10. Subjects did not donate blood or as clinical trial subjects within 3 months before screening
  11. Subjects have good compliance with the protocol
  12. Subjects understood and agreed to sign the informed consent form.

Exclusion Criteria:

  1. Decompensated liver disease: direct bilirubin > 1.2 × ULN,
  2. Prothrombin time > 1.2 × ULN, serum albumin < 35 g / L
  3. Severe liver fibrosis or cirrhosis: METAVIR score of liver biopsy is 4 points; or or Child-Pugh score> 7
  4. Hemocytopenia: neutrophil < 1 × 10^9 / L, platelet < 50 × 10^9 / L, hemoglobin < 100g / L (female) or hemoglobin < 110g / L (male) points
  5. HAV,HCV,HDV,HEV or HIV infection
  6. Pegylated interferon therapy is contraindicated
  7. Allergic to interferon, Such as severe depression, epilepsy, autoimmune diseases, uncontrolled thyroid dysfunction and so on
  8. severe retinopathy or eye disease(Eye diseases due to high blood pressure or diabetes, CMV retinitis, macular degeneration)
  9. Positive for anti-HBV Pre-S1 antibody.
  10. Hamilton Depression Scale (HAMD, 17 items) score > 17 points
  11. Female subjects pregnancy test positive
  12. Other laboratories or auxiliary examinations are obviously abnormal

Information from the National Library of Medicine

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


Contacts
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Contact: Xiaolu Tang 86-21-68412368 ext 619 tangxiaolu@heppharma.com
Contact: Xian Gao 86-21-68412368 ext 620 gaoxian@heppharma.com

Locations
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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         
Sponsors and Collaborators
Shanghai HEP Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Fusheng Wang The fifth medical center of PLA
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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