Back to resultsA Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B
Primary Purpose
Hepatitis B, Chronic
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Adefovir
Entecavir
Placebo
peginterferon alfa-2a [Pegasys]
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic
Eligibility Criteria
Inclusion Criteria:
- adult patients, 18-65 years of age;
- HBeAg+ve for >=3 months;
- positive serum HBV DNA within 3 months prior to entry;
- patients with chronic hepatitis B, either naive to HBV treatment, or not responded/relapsed to nucleoside analogues;
- >=3 months treatment-free interval from nucleotide analogues.
Exclusion Criteria:
- evidence of decompensated liver disease;
- history or other evidence of a medical condition associated with chronic liver disease othr than viral hepatitis;
- co-infection with active hepatitis A,C or D, or HIV.
Sites / Locations
- Changhua Christian Hospital; Internal Medicine
- Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
- Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
- Chang Gung Medical Foundation - Keelung; Dept. of Hepato-Gastroenterology
- China Medical University Hospital; Department of Rheumatology
- National Taiwan Uni Hospital; Gastro-Enterology Dept.
- Taipei Veterans General Hospital; Gastroenterology Division
- Tri-Service Hospital; Dept. of Internal Medicine
- Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment
HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).
Secondary Outcome Measures
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
HBV DNA (copies per milliliter [copies/mL]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication.
Percentage of Participants Who Were HBeAg Negative
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
The normal range for ALT is 10 to 40 international units per liter (IU/L).
Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participants With Combined Response
Combined response was defined as having negative HBeAg, HBV DNA less than (<) 100,000 copies/mL, and normal ALT level (10-40 IU/L).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00922207
Brief Title
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B
Official Title
A Randomized, Open-label Study of the Effect of Peginterferon Alfa-2a (40KD)(PEGASYS) in Combination With Adefovir or Entecavir on HBeAg Seroconversion in Patients With HBeAg Positive Chronic Hepatitis B
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 7, 2010 (Actual)
Primary Completion Date
September 29, 2014 (Actual)
Study Completion Date
September 29, 2014 (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 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or 3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study treatment is 1 year, and the target sample size is 100-500 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
ParticipantInvestigator
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Adefovir
Intervention Description
From week -4 to week 2
Intervention Type
Drug
Intervention Name(s)
Entecavir
Intervention Description
From week -4 to week 2
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
From week -4 to week 2
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 micrograms sc weekly, from week 1-48
Primary Outcome Measure Information:
Title
Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment
Description
HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).
Time Frame
Week 100
Secondary Outcome Measure Information:
Title
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Description
HBV DNA (copies per milliliter [copies/mL]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication.
Time Frame
Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Title
Percentage of Participants Who Were HBeAg Negative
Time Frame
Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Title
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
Time Frame
Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Title
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
Description
The normal range for ALT is 10 to 40 international units per liter (IU/L).
Time Frame
Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100
Title
Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Time Frame
Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Title
Percentage of Participants With Combined Response
Description
Combined response was defined as having negative HBeAg, HBV DNA less than (<) 100,000 copies/mL, and normal ALT level (10-40 IU/L).
Time Frame
Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
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, 18-65 years of age;
HBeAg+ve for >=3 months;
positive serum HBV DNA within 3 months prior to entry;
patients with chronic hepatitis B, either naive to HBV treatment, or not responded/relapsed to nucleoside analogues;
>=3 months treatment-free interval from nucleotide analogues.
Exclusion Criteria:
evidence of decompensated liver disease;
history or other evidence of a medical condition associated with chronic liver disease othr than viral hepatitis;
co-infection with active hepatitis A,C or D, or HIV.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Changhua Christian Hospital; Internal Medicine
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
City
Kaohsiung
ZIP/Postal Code
00833
Country
Taiwan
Facility Name
Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Chang Gung Medical Foundation - Keelung; Dept. of Hepato-Gastroenterology
City
Keelung City
ZIP/Postal Code
204
Country
Taiwan
Facility Name
China Medical University Hospital; Department of Rheumatology
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
National Taiwan Uni Hospital; Gastro-Enterology Dept.
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hospital; Gastroenterology Division
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Tri-Service Hospital; Dept. of Internal Medicine
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B
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