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Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Ypeginterferon alfa-2b
Pegasys
Sponsored by
Xiamen Amoytop Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring peginterferon, HBeAg Positive, Chronic hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 18~65 years.
  • Serum HBsAg or HBV DNA positive for at least 6 months.
  • Serum HBsAg and HBeAg are both positive, HBV DNA ≥ 20,000IU/ml at screening.
  • 2×ULN≤ ALT ≤10×ULN at screening (ULN=upper limit of normal).
  • Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the treatment.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Mental disorder or physical disability.
  • Interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis B treatment within the previous 6 months.
  • ANC < 1500/mm3, or PLT < 90,000/mm3.
  • Co-infection with HAV, HIV, HCV, HDV, or HEV.
  • Both of HBsAg and anti-HBs are positive, or both of HBeAg and anti-HBe are positive at screening.
  • Child-Pugh ≥ B, or other evidence of hepatitis decompensation (e.g.: prothrombin time prolonged more than 3 seconds, TBil > 2ULN, Alb<35g/L).
  • Chronic hepatitis caused by any other reason except hepatitis B.
  • Hepatocarcinoma or suffering from any other malignant tumor.
  • Not well-controlled endocrine diseases (e.g.: thyroid dysfunction, diabetes mellitus)
  • Significant function damage in any major organs (e.g.: heart, lung, kidney).
  • Other Conditions which in the opinion of the investigator precluding enrollment into the study (e.g.: poor compliance).

Sites / Locations

  • Xiamen Hospital of T.C.M
  • Beijing University Shenzhen Hospital
  • 302 Military Hospital
  • Beijing Ditan Hospital Capital Medical University
  • Beijing Youan Hospital, Capital Medical University
  • Beijing Youyi Hospital, Capital Medical University
  • Peking University First Hospital
  • Peking University People's Hospital
  • First Affiliated Hospital of Jilin University
  • Xiangya Hospital, Central-south University
  • Xiangya Second Hospital, Central-south University
  • West China Hospital, Sichuan University
  • Second Affiliated Hospital Chongqing Medical University
  • Southwest Hospital
  • Fuzhou Infectious Disease Hospital
  • Guangzhou Eighth People's Hospital
  • Nanfang Hospital
  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital, Zhejiang University
  • Second Affiliated Hospital of Harbin Medical University
  • Jinan Infectious Disease Hospital
  • First Affiliated Hospital of Lanzhou University
  • 81 Military Hospital
  • First Affiliated Hospital of Nanchang University
  • Jiangsu Province Hospital
  • Second Hospital of Nanjing
  • 85 Military Hospital
  • Huashan Hospital
  • Ruijing Hospital
  • Shanghai Public Health Clinical Center
  • Shengjing Hospital of China Medical University
  • Shenyang Sixed People's Hospital
  • Third Affiliated Hospital, Hebei Medical University
  • First Affiliated Hospital, Shanxi University
  • Tianjin Third Central Hospital
  • First Affiliated Hospital of Wenzhou Medical College
  • Tongji Hospital, Huazhong University of Science & Technology
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • First Affiliated Hospital of Xinjiang Medical University
  • Tangdu Hospital, Fourth Military Medical University
  • Xijing Hospital
  • The First Affiliated Hospital of Xiamen University
  • Henan Provincial People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ypeginterferon Alfa-2b

Pegasys

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients with HBeAg seroconversion at week72

Secondary Outcome Measures

Proportion of Patients with HBeAg seroconversion at week 12,24,48
Proportion fo patients with HBeAg undetectable at week 12, 24, 48, and 72.
Average of HBV DNA decline level at week 12, 24,48 and 72
Average of HBsAg decline level at week 12, 24, 48 and 72, and Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 12, 24, 48 and 72.
Proportion of patients with ALT normalization at week 12,24, 48 and 72.

Full Information

First Posted
December 30, 2012
Last Updated
August 28, 2015
Sponsor
Xiamen Amoytop Biotech Co., Ltd.
Collaborators
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01760122
Brief Title
Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
Official Title
A Phase 3, Randomized, Multi-center, Active-controlled, Open-label Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b (40kD, Y Shape) in Chinese Chronic Hepatitis B Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiamen Amoytop Biotech Co., Ltd.
Collaborators
Peking University First Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD, Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient evidences for the listed of the studied drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
peginterferon, HBeAg Positive, Chronic hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
820 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ypeginterferon Alfa-2b
Arm Type
Experimental
Arm Title
Pegasys
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ypeginterferon alfa-2b
Intervention Description
sc, qw, 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Pegasys
Intervention Description
sc, qw, 48 weeks.
Primary Outcome Measure Information:
Title
Proportion of patients with HBeAg seroconversion at week72
Time Frame
24 weeks after the cessation of treatment
Secondary Outcome Measure Information:
Title
Proportion of Patients with HBeAg seroconversion at week 12,24,48
Time Frame
week 12, 24, 48 from treatment starting
Title
Proportion fo patients with HBeAg undetectable at week 12, 24, 48, and 72.
Time Frame
week 4, 12, 24, 48 and 72 from treatment starting
Title
Average of HBV DNA decline level at week 12, 24,48 and 72
Time Frame
week 12, 24, 48 and 72 from treatment starting
Title
Average of HBsAg decline level at week 12, 24, 48 and 72, and Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 12, 24, 48 and 72.
Time Frame
week 12, 24, 48 and 72 from treatment starting
Title
Proportion of patients with ALT normalization at week 12,24, 48 and 72.
Time Frame
week 12, 24, 48 and 72 from treatment starting

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18~65 years. Serum HBsAg or HBV DNA positive for at least 6 months. Serum HBsAg and HBeAg are both positive, HBV DNA ≥ 20,000IU/ml at screening. 2×ULN≤ ALT ≤10×ULN at screening (ULN=upper limit of normal). Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the treatment. Exclusion Criteria: Pregnant or lactating women. Mental disorder or physical disability. Interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis B treatment within the previous 6 months. ANC < 1500/mm3, or PLT < 90,000/mm3. Co-infection with HAV, HIV, HCV, HDV, or HEV. Both of HBsAg and anti-HBs are positive, or both of HBeAg and anti-HBe are positive at screening. Child-Pugh ≥ B, or other evidence of hepatitis decompensation (e.g.: prothrombin time prolonged more than 3 seconds, TBil > 2ULN, Alb<35g/L). Chronic hepatitis caused by any other reason except hepatitis B. Hepatocarcinoma or suffering from any other malignant tumor. Not well-controlled endocrine diseases (e.g.: thyroid dysfunction, diabetes mellitus) Significant function damage in any major organs (e.g.: heart, lung, kidney). Other Conditions which in the opinion of the investigator precluding enrollment into the study (e.g.: poor compliance).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Guiqiang, Ph.D
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiamen Hospital of T.C.M
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361000
Country
China
Facility Name
Beijing University Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518036
Country
China
Facility Name
302 Military Hospital
City
Beijing
Country
China
Facility Name
Beijing Ditan Hospital Capital Medical University
City
Beijing
Country
China
Facility Name
Beijing Youan Hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
Beijing Youyi Hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
Peking University First Hospital
City
Beijing
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
Facility Name
First Affiliated Hospital of Jilin University
City
Changchun
Country
China
Facility Name
Xiangya Hospital, Central-south University
City
Changsha
Country
China
Facility Name
Xiangya Second Hospital, Central-south University
City
Changsha
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
Country
China
Facility Name
Second Affiliated Hospital Chongqing Medical University
City
Chongqing
Country
China
Facility Name
Southwest Hospital
City
Chongqing
Country
China
Facility Name
Fuzhou Infectious Disease Hospital
City
Fuzhou
Country
China
Facility Name
Guangzhou Eighth People's Hospital
City
Guangzhou
Country
China
Facility Name
Nanfang Hospital
City
Guangzhou
Country
China
Facility Name
First Affiliated Hospital of Guangxi Medical University
City
Guilin
Country
China
Facility Name
First Affiliated Hospital, Zhejiang University
City
Hangzhou
Country
China
Facility Name
Second Affiliated Hospital of Harbin Medical University
City
Harbin
Country
China
Facility Name
Jinan Infectious Disease Hospital
City
Jinan
Country
China
Facility Name
First Affiliated Hospital of Lanzhou University
City
Lanzhou
Country
China
Facility Name
81 Military Hospital
City
Nanchang
Country
China
Facility Name
First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
Country
China
Facility Name
Second Hospital of Nanjing
City
Nanjing
Country
China
Facility Name
85 Military Hospital
City
Shanghai
Country
China
Facility Name
Huashan Hospital
City
Shanghai
Country
China
Facility Name
Ruijing Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
Country
China
Facility Name
Shenyang Sixed People's Hospital
City
Shenyang
Country
China
Facility Name
Third Affiliated Hospital, Hebei Medical University
City
Shijiazhuang
Country
China
Facility Name
First Affiliated Hospital, Shanxi University
City
Taiyuan
Country
China
Facility Name
Tianjin Third Central Hospital
City
Tianjin
Country
China
Facility Name
First Affiliated Hospital of Wenzhou Medical College
City
Wenzhou
Country
China
Facility Name
Tongji Hospital, Huazhong University of Science & Technology
City
Wuhan
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
Country
China
Facility Name
First Affiliated Hospital of Xinjiang Medical University
City
Wulumuqi
Country
China
Facility Name
Tangdu Hospital, Fourth Military Medical University
City
Xi'an
Country
China
Facility Name
Xijing Hospital
City
Xi'an
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
Country
China

12. IPD Sharing Statement

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Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B

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