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A Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (Pegasys) and Adeforvir Dipivoxil (ADV) in Participants With Lamivudine-Resistant Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Adefovir dipivoxil
Lamivudine
Peginterferon alfa-2a
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 participants 18-65 years of age
  • Hepatitis B surface antigen (HBsAg)-positive, HBeAg-positive, and anti-HBs-negative for greater than or equal to (>=) 6 months
  • Receiving lamivudine currently, and for >=6 months
  • hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) decreased >=2 log during lamivudine treatment on >=1 occasion
  • Absence of cirrhosis confirmed by liver biopsy in previous 6 months

Exclusion Criteria:

  • Other drugs with activity against HBV within the prior 6 months, except lamivudine
  • Antiviral, anti-neoplastic, or immunomodulatory therapy less than or equal to (<=) 6 months before study - Active infection with hepatitis A, C, or D virus, or human immunodeficiency virus
  • Decompensated liver disease
  • Medical condition associated with another chronic liver disease

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ADV + Lamivudine

Peginterferon alfa-2a + Lamivudine

Arm Description

Participants will receive ADV and lamivudine tablets at a dose of 10 mg orally QD for first 12 weeks followed by ADV for 60 weeks.

Participants will receive peginterferon alfa-2a injection at a dose of 180 micrograms (mcg) once weekly (QW) and 100 milligrams (mg) lamivudine tablets orally once daily (QD) for first 12 weeks followed by peginterferon alfa-2a for 36 weeks.

Outcomes

Primary Outcome Measures

HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) at Week 72

Secondary Outcome Measures

Loss of HBeAg
Reduction in hepatitis B virus deoxyribonucleic acid (HBV DNA)
Alanine transaminase (ALT) normalization
Hepatitis B surface antigen (HBsAg) seroconversion

Full Information

First Posted
November 4, 2015
Last Updated
February 1, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02598063
Brief Title
A Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (Pegasys) and Adeforvir Dipivoxil (ADV) in Participants With Lamivudine-Resistant Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B
Official Title
A Randomized, Open-label Study Evaluating the Efficacy and Safety of Peginterferon Alfa-2a (40KD) (PEGASYS®) or Adefovir Dipivoxil (ADV) in Patients With Lamivudine-resistant HBeAg Positive Chronic Hepatitis B
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This study will evaluate the efficacy and safety of peginterferon alfa-2a or ADV, in participants with lamivudine-resistant HBeAg-positive chronic hepatitis B. Participants will be randomized to receive either peginterferon alfa-2a for 48 weeks in combination with oral lamivudine for the first 12 weeks, or ADV for 72 weeks in combination with oral lamivudine for the first 12 weeks. The anticipated time on study treatment is 72 weeks, and the target sample size is 255 individuals.

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
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADV + Lamivudine
Arm Type
Active Comparator
Arm Description
Participants will receive ADV and lamivudine tablets at a dose of 10 mg orally QD for first 12 weeks followed by ADV for 60 weeks.
Arm Title
Peginterferon alfa-2a + Lamivudine
Arm Type
Experimental
Arm Description
Participants will receive peginterferon alfa-2a injection at a dose of 180 micrograms (mcg) once weekly (QW) and 100 milligrams (mg) lamivudine tablets orally once daily (QD) for first 12 weeks followed by peginterferon alfa-2a for 36 weeks.
Intervention Type
Drug
Intervention Name(s)
Adefovir dipivoxil
Intervention Description
ADV will be administered orally at a dose of 10 mg QD for 72 weeks.
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Description
Lamivudine tablets will be administered orally at a dose of 10 mg QD for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
Peginterferon alfa-2a injection will be administered at a dose of 180 mcg QW for 48 weeks.
Primary Outcome Measure Information:
Title
HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) at Week 72
Time Frame
Week 72
Secondary Outcome Measure Information:
Title
Loss of HBeAg
Time Frame
Week 48, and 72
Title
Reduction in hepatitis B virus deoxyribonucleic acid (HBV DNA)
Time Frame
Week 48, and 72
Title
Alanine transaminase (ALT) normalization
Time Frame
Week 48, and 72
Title
Hepatitis B surface antigen (HBsAg) seroconversion
Time Frame
Week 48, and 72

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 participants 18-65 years of age Hepatitis B surface antigen (HBsAg)-positive, HBeAg-positive, and anti-HBs-negative for greater than or equal to (>=) 6 months Receiving lamivudine currently, and for >=6 months hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) decreased >=2 log during lamivudine treatment on >=1 occasion Absence of cirrhosis confirmed by liver biopsy in previous 6 months Exclusion Criteria: Other drugs with activity against HBV within the prior 6 months, except lamivudine Antiviral, anti-neoplastic, or immunomodulatory therapy less than or equal to (<=) 6 months before study - Active infection with hepatitis A, C, or D virus, or human immunodeficiency virus Decompensated liver disease Medical condition associated with another chronic liver disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Beijing
ZIP/Postal Code
100044
Country
China
City
Beijing
ZIP/Postal Code
100050
Country
China
City
Beijing
ZIP/Postal Code
100054
Country
China
City
Chongqing
ZIP/Postal Code
400038
Country
China
City
Guangzhou
ZIP/Postal Code
510515
Country
China
City
Hangzhou
ZIP/Postal Code
310003
Country
China
City
Jinan
ZIP/Postal Code
250021
Country
China
City
Shanghai
ZIP/Postal Code
200025
Country
China
City
Shanghai
ZIP/Postal Code
200040
Country
China
City
Shanghai
ZIP/Postal Code
201508
Country
China
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (Pegasys) and Adeforvir Dipivoxil (ADV) in Participants With Lamivudine-Resistant Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B

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