search
Back to results

A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Adefovir
peginterferon alfa-2a [PEGASYS]
peginterferon alfa-2a [PEGASYS]
peginterferon alfa-2a [PEGASYS]
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic

Eligibility Criteria

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

Inclusion Criteria:

  • Adult patients >/=18 years of age
  • HBeAg positive chronic hepatitis B
  • Compensated liver disease

Exclusion Criteria:

  • Patients who had previously received treatment of drugs with activity against HBV within 6 months prior to study start
  • Antiviral, anti-neoplastic or immunomodulatory treatment
  • Co-infection with active hepatitis A, hepatitis C, hepatitis D, or HIV
  • Evidence of decompensated liver disease
  • Chronic liver disease other than viral hepatitis

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

A

B

C

D

Arm Description

Outcomes

Primary Outcome Measures

Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction)

Secondary Outcome Measures

Proportion of patients achieving HBeAG seroconversion and HBV DNA </=100000 copies/ml
Safety: Adverse Events

Full Information

First Posted
March 11, 2010
Last Updated
November 1, 2016
Sponsor
Hoffmann-La Roche
Collaborators
Major Science and Technology Special Project of China Eleventh Five-year
search

1. Study Identification

Unique Protocol Identification Number
NCT01086085
Brief Title
A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive
Official Title
A Study on Optimizing the Treatment in HBeAg Positive CHB Patients With Response Guide Treatment (RGT) Method.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Major Science and Technology Special Project of China Eleventh Five-year

4. Oversight

5. Study Description

Brief Summary
This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a [PEGASYS] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is >2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Experimental
Arm Title
D
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Adefovir
Intervention Description
Adefovir 10 mg po once daily for 36 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [PEGASYS]
Intervention Description
Early responders: PEGASYS 180 mcg sc once weekly for 48 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [PEGASYS]
Intervention Description
Non-early responders: PEGASYS 180 mcg sc once weekly for 48 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [PEGASYS]
Intervention Description
Non-early responders: PEGASYS 180 mcg sc once weekly for 96 weeks
Primary Outcome Measure Information:
Title
Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction)
Time Frame
Weeks 72, 96, 120
Secondary Outcome Measure Information:
Title
Proportion of patients achieving HBeAG seroconversion and HBV DNA </=100000 copies/ml
Time Frame
Weeks 24, 48, 72, 96, 120
Title
Safety: Adverse Events
Time Frame
From baseline to Week 120

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: Adult patients >/=18 years of age HBeAg positive chronic hepatitis B Compensated liver disease Exclusion Criteria: Patients who had previously received treatment of drugs with activity against HBV within 6 months prior to study start Antiviral, anti-neoplastic or immunomodulatory treatment Co-infection with active hepatitis A, hepatitis C, hepatitis D, or HIV Evidence of decompensated liver disease Chronic liver disease other than viral hepatitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Beijing
ZIP/Postal Code
100011
Country
China
City
Beijing
ZIP/Postal Code
100034
Country
China
City
Beijing
ZIP/Postal Code
100044
Country
China
City
Beijing
ZIP/Postal Code
100050
Country
China
City
Changchun
ZIP/Postal Code
130021
Country
China
City
Guangzhou
ZIP/Postal Code
510515
Country
China
City
Shanghai
ZIP/Postal Code
200025
Country
China
City
Shanghai
ZIP/Postal Code
200040
Country
China
City
Shanghai
ZIP/Postal Code
200433
Country
China
City
Wuhan
ZIP/Postal Code
430030
Country
China
City
Xi'an
ZIP/Postal Code
710038
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
27238752
Citation
Sun J, Ma H, Xie Q, Xie Y, Sun Y, Wang H, Shi G, Wan M, Niu J, Ning Q, Yu Y, Zhou H, Cheng J, Kang W, Xie Y, Fan R, Wei L, Zhuang H, Jia J, Hou J. Response-guided peginterferon therapy in patients with HBeAg-positive chronic hepatitis B: A randomized controlled study. J Hepatol. 2016 Oct;65(4):674-682. doi: 10.1016/j.jhep.2016.05.024. Epub 2016 May 26.
Results Reference
derived

Learn more about this trial

A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive

We'll reach out to this number within 24 hrs