Back to resultsA Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive Patients With HBeAg-Positive Chronic Hepatitis B.
Primary Purpose
Hepatitis B, Chronic
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Entecavir
Entecavir
peginterferon alfa-2a [Pegasys]
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;
- HBsAg positive, HBeAg positive and anti-HBe negative for at least 6 months, anti-HBs negative;
- absence of cirrhosis confirmed by liver biopsy in previous 12 months.
Exclusion Criteria:
- previous treatment for chronic hepatitis B within previous 6 months;
- antiviral, anti-neoplastic or immunomodulatory treatment in previous 6 months;
- co-infection with active hepatitis A, hepatitis C, hepatitis D or HIV;
- history or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Log change in quantitative HBeAg from baseline to 24 weeks after end of treatment.
Secondary Outcome Measures
HBeAg seroconversion, HBV-DNA <1000 copies/mL, loss of HBeAg, HBV DNA reduction, ALT normalization, loss of HBsAg seroconversion, reduction of HBsAg 24 weeks after end of treatment.
AEs, laboratory parameters.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00614471
Brief Title
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive Patients With HBeAg-Positive Chronic Hepatitis B.
Official Title
A Randomized, Open Label Study of the Effect of Peginterferon Alfa-2a (40KD) (PEGASYS®) Plus Entecavir (Baraclude®) Combination Therapy on Quantitative Changes in HBeAg in Treatment-naive Patients With HBeAg Positive Chronic Hepatitis B
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 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 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination therapy in treatment-naive patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms s.c./week for 48 weeks, 2)PEGASYS 180 micrograms s.c./week for 48 weeks + entecavir 0.5mg p.o. once daily from week 13 to week 36 or 3) entecavir 0.5mg p.o. once daily for 24 weeks + PEGASYS 180 micrograms s.c./week from week 21 to 68. Treatment will be followed by 24 weeks treatment-free follow up. The anticipated time on study treatment is 3-12 months for groups 1 and 2, and 1-2 years for group 3, 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
None (Open Label)
Allocation
Randomized
Enrollment
219 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Entecavir
Intervention Description
0.5mg po daily for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Entecavir
Intervention Description
0.5mg po daily from week 13 to week 36
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 micrograms sc/week for 48 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 micrograms sc/week from week 21 to week 68
Primary Outcome Measure Information:
Title
Log change in quantitative HBeAg from baseline to 24 weeks after end of treatment.
Time Frame
Week 72 for Arms 1 and 2. Week 92 for Arm 3.
Secondary Outcome Measure Information:
Title
HBeAg seroconversion, HBV-DNA <1000 copies/mL, loss of HBeAg, HBV DNA reduction, ALT normalization, loss of HBsAg seroconversion, reduction of HBsAg 24 weeks after end of treatment.
Time Frame
Week 72 for Arms 1 and 2. Week 92 for Arm 3.
Title
AEs, laboratory parameters.
Time Frame
Throughout study
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;
HBsAg positive, HBeAg positive and anti-HBe negative for at least 6 months, anti-HBs negative;
absence of cirrhosis confirmed by liver biopsy in previous 12 months.
Exclusion Criteria:
previous treatment for chronic hepatitis B within previous 6 months;
antiviral, anti-neoplastic or immunomodulatory treatment in previous 6 months;
co-infection with active hepatitis A, hepatitis C, hepatitis D or HIV;
history or other evidence of a medical condition associated with 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
Hangzhou
ZIP/Postal Code
310003
Country
China
City
Shanghai
ZIP/Postal Code
200021
Country
China
City
Shanghai
ZIP/Postal Code
200025
Country
China
City
Shanghai
ZIP/Postal Code
200235
Country
China
City
Xi'an
ZIP/Postal Code
710038
Country
China
City
Zhengzhou
ZIP/Postal Code
450052
Country
China
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
25190434
Citation
Xie Q, Zhou H, Bai X, Wu S, Chen JJ, Sheng J, Xie Y, Chen C, Chan HL, Zhao M. A randomized, open-label clinical study of combined pegylated interferon Alfa-2a (40KD) and entecavir treatment for hepatitis B "e" antigen-positive chronic hepatitis B. Clin Infect Dis. 2014 Dec 15;59(12):1714-23. doi: 10.1093/cid/ciu702. Epub 2014 Sep 4.
Results Reference
derived
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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive Patients With HBeAg-Positive Chronic Hepatitis B.
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