Optimized Treatment of Peginterferon Alfa 2a/2b in Treatment Experienced Patients With HBV Related Liver Fibrosis (HBV)

May 20, 2019 updated by: Liang Peng, Third Affiliated Hospital, Sun Yat-Sen University

Study on Optimized Treatment of Peginterferon Alfa 2a or 2b in Anti-virus Treatment Experienced Patients With Hepatitis b Virus Related Liver Fibrosis

Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to investigate treatment of peginterferon alfa 2a/2b in anti-virus treatment experienced patients with HBV related liver fibrosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. But there still lacks of studies on peginterferon alfa 2a or 2b treatment in patients with HBV related liver fibrosis. We design this study to investigate optimized treatment of peginterferon alfa 2a/2b, comparing to nucleoside/nucleotide analogues, in anti-virus treatment experienced patients with HBV related liver fibrosis.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Third Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
  2. Age from 18 to 55 years old;
  3. Fibrosis lever of F1 to F3 from liver biopsy; if liver biopsy unreachable, fibrosis lever of 7 to 14 kpa from fibroscan;
  4. Portal vein diameter ≤ 12 mm from liver ultrasound;
  5. Receiving treatment of nucleoside/nucleotide analogues at the past one year;
  6. Normal liver function;
  7. Undetectable hepatitis b virus DNA.

Exclusion Criteria:

  1. Decompensated cirrhosis, hepatocellular carcinoma or other malignancy;
  2. Pregnancy or lactation;
  3. Other active liver diseases；
  4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
  5. Severe diabetes, autoimmune diseases;
  6. Other important organ dysfunctions;
  7. Patients can not follow-up;
  8. Investigator considering inappropriate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Peginterferon alfa group
50 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg or peginterferon alfa 2b 80μg once per week from baseline to 48 weeks. Then they would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from 49 to 144 weeks.
Drug: Peginterferon Alfa-2a
Patients would receive subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.
Other Names:
  • Pegasys
Drug: Peginterferon Alfa-2b
Patients would receive subcutaneous injection of Peginterferon Alfa-2b 80 μg once per week.
Other Names:
  • Pegintron
Active Comparator: Combination group
50 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg or peginterferon alfa 2b 80μg once per week and meanwhile oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to 48 weeks. Then they would receive treatment of oral TDF 300 mg once per day from 49 to 144 weeks.
Drug: Peginterferon Alfa-2a
Patients would receive subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.
Other Names:
  • Pegasys
Drug: Peginterferon Alfa-2b
Patients would receive subcutaneous injection of Peginterferon Alfa-2b 80 μg once per week.
Other Names:
  • Pegintron
Drug: Tenofovir Disoproxil Fumarate
Patients would receive oral Tenofovir Disoproxil Fumarate 300mg once per day.
Other Names:
  • Viread

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of level of liver fibrosis after anti-virus treatment
Time Frame: 48 week, 144 week
Liver biopsy or fibroscan would be accessed to know the change of level of liver fibrosis at 48 and 144 weeks after anti-virus treatment.
48 week, 144 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of patients with undetectable hepatitis b virus DNA after anti-virus treatment
Time Frame: 24 week, 48 week, 72 week, 96 week, 120 week,144 week
Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 6 time points after anti-virus treatment.
24 week, 48 week, 72 week, 96 week, 120 week,144 week
Ratio of patients with hepatitis b e antigen seroconversion after anti-virus treatment
Time Frame: 24 week, 48 week, 72 week, 96 week, 120 week,144 week
Hepatitis b e antigen and hepatitis b e antibody would be tested to know the ratio of patients with negative hepatitis B e antigen and positive hepatitis B e antibody at 6 time points after anti-virus treatment.
24 week, 48 week, 72 week, 96 week, 120 week,144 week
Ratio of patients with hepatitis b surface antigen seroconversion after anti-virus treatment
Time Frame: 24 week, 48 week, 72 week, 96 week, 120 week,144 week
Hepatitis b surface antigen and hepatitis b surface antibody would be tested to know the ratio of patients with negative hepatitis B surface antigen and positive hepatitis B surface antibody at 6 time points after anti-virus treatment.
24 week, 48 week, 72 week, 96 week, 120 week,144 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Anticipated)

October 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (Actual)

April 19, 2019

Study Record Updates

Last Update Posted (Actual)

May 22, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PL5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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