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

Primary Purpose

Hepatitis B, Liver Fibrosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tenofovir Disoproxil Fumarate
Peginterferon Alfa-2a
Peginterferon Alfa-2b
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring hepatitis b virus, peginterferon alfa, liver fibrosis

Eligibility Criteria

15 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Third Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Peginterferon alfa group

Combination group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of level of liver fibrosis after anti-virus treatment
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.

Secondary Outcome Measures

Ratio of patients with undetectable hepatitis b virus DNA after anti-virus treatment
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.
Ratio of patients with hepatitis b e antigen seroconversion after anti-virus treatment
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.
Ratio of patients with hepatitis b surface antigen seroconversion after anti-virus treatment
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.

Full Information

First Posted
April 16, 2019
Last Updated
May 20, 2019
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03920605
Brief Title
Optimized Treatment of Peginterferon Alfa 2a/2b in Treatment Experienced Patients With HBV Related Liver Fibrosis
Acronym
HBV
Official Title
Study on Optimized Treatment of Peginterferon Alfa 2a or 2b in Anti-virus Treatment Experienced Patients With Hepatitis b Virus Related Liver Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Liver Fibrosis
Keywords
hepatitis b virus, peginterferon alfa, liver fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peginterferon alfa group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Combination group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tenofovir Disoproxil Fumarate
Other Intervention Name(s)
Viread
Intervention Description
Patients would receive oral Tenofovir Disoproxil Fumarate 300mg once per day.
Intervention Type
Drug
Intervention Name(s)
Peginterferon Alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
Patients would receive subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.
Intervention Type
Drug
Intervention Name(s)
Peginterferon Alfa-2b
Other Intervention Name(s)
Pegintron
Intervention Description
Patients would receive subcutaneous injection of Peginterferon Alfa-2b 80 μg once per week.
Primary Outcome Measure Information:
Title
Change of level of liver fibrosis after anti-virus treatment
Description
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.
Time Frame
48 week, 144 week
Secondary Outcome Measure Information:
Title
Ratio of patients with undetectable hepatitis b virus DNA after anti-virus treatment
Description
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.
Time Frame
24 week, 48 week, 72 week, 96 week, 120 week,144 week
Title
Ratio of patients with hepatitis b e antigen seroconversion after anti-virus treatment
Description
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.
Time Frame
24 week, 48 week, 72 week, 96 week, 120 week,144 week
Title
Ratio of patients with hepatitis b surface antigen seroconversion after anti-virus treatment
Description
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.
Time Frame
24 week, 48 week, 72 week, 96 week, 120 week,144 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year; Age from 18 to 55 years old; Fibrosis lever of F1 to F3 from liver biopsy; if liver biopsy unreachable, fibrosis lever of 7 to 14 kpa from fibroscan; Portal vein diameter ≤ 12 mm from liver ultrasound; Receiving treatment of nucleoside/nucleotide analogues at the past one year; Normal liver function; Undetectable hepatitis b virus DNA. Exclusion Criteria: Decompensated cirrhosis, hepatocellular carcinoma or other malignancy; Pregnancy or lactation; Other active liver diseases； Human immunodeficiency virus infection or congenital immune deficiency diseases; Severe diabetes, autoimmune diseases; Other important organ dysfunctions; Patients can not follow-up; Investigator considering inappropriate.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenxiong Xu, Doctor
Phone
+8613760783281
Email
xwx1983@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Peng, Doctor
Phone
+8613533978874
Email
pzp33@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang Peng, Doctor
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Peng, Doctor
Phone
+8613533978874
Email
pzp33@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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