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A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients

NCT05244057 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-07-15

No results posted yet for this study

Summary

The study is designed to assess efficacy of a finitie treatment in Chronic Hepatitis B patients who had stable treatment of NAs for ≧ 2 years， which is compared hepalatide in combination with Pegylated Interferon + TAF with Pegylated Interferon +TAF. Subjects will be randomly assigned to the hepalatide or placebo groups , 15 subjects in each group . Subjects will receive hepalatide+Pegylated Interferon +TAF treatment for 48 weeks or placebo +PegylatedInterferon +TAF treatment for 48 weeks , Then, stopping hepalatide and Pegylate Interferon treatments and followed with further 8 weeks follow-up.

Conditions

Interventions

DRUG

Hepalatide

6.3mg, s.c., qd for 48 weeks

DRUG

Placebo of Hepalatide

s.c., qd for 48 weeks

DRUG

Tenofovir Alafenamide Tablets

25mg, p.o., qd for 48 weeks

DRUG

Pegylated Interferon alfa 2a

90ug, s.c., qw for 48 weeks

Sponsors & Collaborators

  • Shanghai Tong Ren Hospital

    collaborator OTHER

  • Shanghai East Hospital

    collaborator OTHER

  • Shanghai HEP Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Qin Zhang · Shanghai Tong Ren Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-23
Primary Completion
2024-06-24
Completion
2024-06-24

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05244057 on ClinicalTrials.gov