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CompletedNCT04426968Updated Jan 27, 2025

A Phase II Study of Hepalatide in Subjects With Chronic Hepatitis B

A Phase 2 interventional study of Hepalatide 2.1mg and Hepalatide 4.2mg in Hepatitis B, Chronic, sponsored by Shanghai HEP Pharmaceutical Co., Ltd.. Completed at 12 sites in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-01-27.

Sponsored by Shanghai HEP Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Hepatitis B, Chronic
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
96 participants (actual)

Study arms

  • Experimental
    Hepalatide 2.1mg+Pegylated Interferon

    Hepalatide 2.1mg s.c., q.d., treatment continued for 24 weeks, follow up 4 weeks. PEG-IFNalpha, s.c., q.w.,treatment continued for 48 weeks

    Drug: Hepalatide 2.1mg · Drug: Pegylated Interferon

  • Experimental
    Hepalatide 4.2mg+Pegylated Interferon

    Hepalatide 4.2mg s.c., q.d., treatment continued for 24 weeks, follow up 4 weeks. PEG-IFNalpha, s.c., q.w.,treatment continued for 48 weeks

    Drug: Hepalatide 4.2mg · Drug: Pegylated Interferon

  • Experimental
    Hepalatide 6.3mg+Pegylated Interferon

    Hepalatide 6.3mg s.c., q.d., treatment continued for 24 weeks, follow up 4 weeks. PEG-IFNalpha, s.c., q.w.,treatment continued for 48 weeks

    Drug: Hepalatide 6.3mg · Drug: Pegylated Interferon

  • Active comparator
    placebo+Pegylated Interferon

    Hepalatide placebo s.c., q.d., treatment continued for 24 weeks, follow up 4 weeks. PEG-IFNalpha, s.c., q.w.,treatment continued for 48 weeks

    Drug: placebo 2.1mg · Drug: placebo 4.2mg · Drug: placebo 6.3mg · Drug: Pegylated Interferon

Interventions

  • DrugHepalatide 2.1mg

    2.1 mg/day subcutaneously (s.c.) for 24 week

    Also known as: L47

  • DrugHepalatide 4.2mg

    4.2mg/day subcutaneously (s.c.) for 24 week

    Also known as: L47

  • DrugHepalatide 6.3mg

    6.3mg/day subcutaneously (s.c.) for 24 week

    Also known as: L47

  • Drugplacebo 2.1mg

    2.1 mg/day subcutaneously (s.c.) for 24 week

  • Drugplacebo 4.2mg

    4.2 mg/day subcutaneously (s.c.) for 24 week

  • Drugplacebo 6.3mg

    6.3 mg/day subcutaneously (s.c.) for 24 week

  • DrugPegylated Interferon

    180 ug/week subcutaneously (s.c.) for 28 week

    Also known as: Pegasys

05

What researchers measure

Primary outcomes

  1. virological response

    Time frame: 24weeks

Secondary outcomes

  1. HBV DNA down from baseline

    HBV DNA down from baseline log10

    Time frame: 24weeks

Other outcomes

  1. Virological suppression

    HBV DNA \<2,000 IU/ml

    Time frame: 24weeks

  2. No response

    HBsAg \>20,000 IU/ml and HBV DNA lower than baseline \<2log10 IU/ml

    Time frame: 24weeks

  3. Partial virological response

    HBV DNA \>20 IU/ml and ≥2log10 IU/ml lower than baseline

    Time frame: 24weeks

  4. HBsAg is down from baseline

    HBsAg is down from baseline log10

    Time frame: 24weeks

  5. HBeAg turned negative

    HBeAg \<0.05 index

    Time frame: 24weeks

  6. HBeAg is down from baseline

    HBeAg is down from baseline log10

    Time frame: 24weeks

  7. ALT recurrence

    ALT≤1.25×ULN

    Time frame: 24weeks

  8. Histological response

    Liver tissue inflammatory necrosis score reduced by ≥2 points with no increased liver fibrosis score; liver fibrosis score reduced by ≥1 point

    Time frame: 24weeks

06

Study locations

12 sites
  • The fifth medical center of PLA
    Beijing, Beijing 100039, China
  • Jilin Hepatobiliary Disease Hospital
    Changchun, China
  • The first hospital of Jilin University
    Changchun, China
  • Chizhou People's Hospital
    Chizhou, China
  • The First Hospital Affiliated to the Army Medical University
    Chongqing, China
  • The First Affiliated Hospital of Nanchang University
    Nanchang, China
  • The Second Hospital of Nanjing
    Nanjing, China
  • Qingyuan People's Hospital
    Qingyuan, China
  • Shanghai Tongren Hospital
    Shanghai, China
  • The Sixth People's Hospital of Shenyang
    Shenyang, China
  • Henan Provincial People's Hospital
    Zhengzhou, China
  • Henan Provincial Infectious Disease Hospital
    Zhenzhou, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04426968
Lead sponsor
Shanghai HEP Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jun 11, 2020
Start date
Jun 18, 2021
Primary completion
Nov 1, 2023
Completion
Nov 29, 2023
Last update
Jan 27, 2025

Study contacts

Fusheng Wang
principal investigator · The fifth medical center of PLA

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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