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

Primary Purpose

Chronic Hepatitis B

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ypeginterferon alfa-2b
Peginterferon alfa-2a
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, interferon, Pegasys, HBV, Hepatitis B, HBeAg positive

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age:18~60 years.
  • Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the cessation of treatment.
  • Serum HBsAg positive for at least 6 months.
  • Serum HBeAg positive with HBV DNA ≥20,000IU/ml.
  • 2×ULN≤ALT≤10×ULN at screening(ULN=upper limit of normal).

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.
  • WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm3.
  • Co-infection with HAV, HIV, HCV, HDV, HEV.
  • Both HBsAg and anti-HBs are positive, or both HBeAg and anti-HBe are positive at screening.
  • Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
  • Evidence of hepatic decompensation.
  • History of hypothyroidism or current treatment for thyroid disease.
  • Uncontrolled significant chronic medical conditions other than chronic hepatitis B, or other conditions which in the opinion of the investigator preclude enrollment into the study.

Sites / Locations

  • 302 Military Hospital
  • 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
  • Southwest Hospital
  • Fuzhou Infectious Disease Hospital
  • Guangzhou Eighth People's Hospital
  • Nanfang Hospital
  • Third Affiliated Hospital of Sun Yat-sen University
  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital, Zhejiang University
  • Second Affiliated Hospital of Harbin Medical University
  • First Affiliated Hospital of Anhui Medical University
  • Jinan Infectious Disease Hospital
  • First Affiliated Hospital of Lanzhou University
  • First Affiliated Hospital of Nanchang University
  • 81 Military Hospital
  • Jiangsu Province Hospital
  • Second Hospital of Nanjing
  • 85 Militay Hospital
  • Changhai Hospital
  • Huashan Hospital
  • Renji Hospital
  • Ruijin Hospital
  • Shanghai Public Health Clinical Center
  • Shenzhen Third 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
  • Tangdu Hospital, Fourth Military Medical University
  • First Affiliated Hospital of Zhengzhou University
  • Henan Provincial People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

Ypeginterferon alfa-2b 90mcg per week

Ypeginterferon alfa-2b 135mcg per week

Ypeginterferon alfa-2b 180mcg per week

Pegasys 180mcg per week

Outcomes

Primary Outcome Measures

Efficacy
Average of HBV DAN decline level at week 24. Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 24.

Secondary Outcome Measures

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

Full Information

First Posted
June 11, 2010
Last Updated
January 31, 2013
Sponsor
Xiamen Amoytop Biotech Co., Ltd.
Collaborators
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01143662
Brief Title
Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
Official Title
A Multi-center, Randomized, Open-label and Positive Controlled Phase II Clinical Trial to Assess Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Patients With Chronic Hepatitis B
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2012 (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
Yes

5. Study Description

Brief Summary
This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3 dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis B characterized by HBeAg positivity, with Pegasys 180mcg/week as positive control. It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate pharmacokinetic data of Ypeginterferon alfa-2b in hepatitis B patients to satisfy regulatory requirements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
peginterferon, interferon, Pegasys, HBV, Hepatitis B, HBeAg positive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Ypeginterferon alfa-2b 90mcg per week
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Ypeginterferon alfa-2b 135mcg per week
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Ypeginterferon alfa-2b 180mcg per week
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
Pegasys 180mcg per week
Intervention Type
Drug
Intervention Name(s)
Ypeginterferon alfa-2b
Intervention Description
sc, qw, for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
sc, qw, for 48 weeks.
Primary Outcome Measure Information:
Title
Efficacy
Description
Average of HBV DAN decline level at week 24. Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 24.
Time Frame
week 24 from treatment start
Secondary Outcome Measure Information:
Title
Efficacy
Description
Average of HBV DNA decline level at week 12, 48 and 72. Proportion of patients with HBV DNA undetectable at week 48 and 72. Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 48 and 72. Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 48 and 72. Proportion of patients with ALT normalization at week 24 and 48.
Time Frame
week 12, 24, 48 from treatment start and week 24 after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age:18~60 years. Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the cessation of treatment. Serum HBsAg positive for at least 6 months. Serum HBeAg positive with HBV DNA ≥20,000IU/ml. 2×ULN≤ALT≤10×ULN at screening(ULN=upper limit of normal). 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. WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm3. Co-infection with HAV, HIV, HCV, HDV, HEV. Both HBsAg and anti-HBs are positive, or both HBeAg and anti-HBe are positive at screening. Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease. Evidence of hepatic decompensation. History of hypothyroidism or current treatment for thyroid disease. Uncontrolled significant chronic medical conditions other than chronic hepatitis B, or other conditions which in the opinion of the investigator preclude enrollment into the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Guiqiang, MD, PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
302 Military Hospital
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
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
Third Affiliated Hospital of Sun Yat-sen University
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
First Affiliated Hospital of Anhui Medical University
City
Hefei
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
First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Facility Name
81 Military Hospital
City
Nanjing
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
Country
China
Facility Name
Second Hospital of Nanjing
City
Nanjing
Country
China
Facility Name
85 Militay Hospital
City
Shanghai
Country
China
Facility Name
Changhai Hospital
City
Shanghai
Country
China
Facility Name
Huashan Hospital
City
Shanghai
Country
China
Facility Name
Renji Hospital
City
Shanghai
Country
China
Facility Name
Ruijin Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
Country
China
Facility Name
Shenzhen Third People's Hospital
City
Shenzhen
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
Tangdu Hospital, Fourth Military Medical University
City
Xian
Country
China
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
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 Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B

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