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The Optimizing Treatment of Peginterferon (PEG IFN) Alpha in Chronic Hepatitis B Virus Patients With Low Level HBsAg

NCT02893124 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-05-22

No results posted yet for this study

Summary

HBeAg-negative chronic hepatitis B (CHB) patients with low Level HBsAg and with a history of drug resistance or suboptimal/partial virological response were enrolled. After giving informed consent, patients were treated with nucleoside analog(s) (NAs) once a day and weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 12 weeks. 12 weeks later, NAs was stopped, patients were treated with weekly subcutaneous injections of alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. Treatment endpoint was HBsAg loss(\<0.05 IU/mL).

Conditions

Interventions

DRUG

peginterferon alfa

peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week, for at most 96 weeks.

Sponsors & Collaborators

  • Peking University

    collaborator OTHER

  • Huazhong University of Science and Technology

    collaborator OTHER

  • Nanchang University

    collaborator OTHER

  • Huizhou Municipal Central Hospital

    collaborator OTHER

  • First People's Hospital, Shunde China

    collaborator OTHER

  • Shenzhen Third People's Hospital

    collaborator OTHER

  • First People's Hospital of Foshan

    collaborator OTHER

  • Tang-Du Hospital

    collaborator OTHER

  • First Affiliated Hospital of Kunming Medical University

    collaborator OTHER

  • Yuebei People's Hospital

    collaborator OTHER

  • Third Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2019-08-31
Completion
2019-08-31

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 NCT02893124 on ClinicalTrials.gov