Back to resultsA Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)
Primary Purpose
Hepatitis B, Chronic
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Peginterferon alfa-2a
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B, Chronic
Eligibility Criteria
Inclusion Criteria:
- Adult participants between 18 to 65 years of age
- HBeAg-positive chronic HBV
- Treatment-naive, or have received and have not responded to or have relapsed on either conventional interferon or lamivudine therapy.
Exclusion Criteria:
- Antiviral or interferon-based therapy for chronic HBV within 6 months of enrollment
- Co-infection with active hepatitis A, C or D virus or with human immunodeficiency virus (HIV)
- Evidence of decompensated liver disease
- 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
Experimental
Experimental
Experimental
Arm Label
Group A (Naïve Participants)
Group B (Conventional Interferon Pretreated Participants)
Group C (Lamivudine Pretreated Participants)
Arm Description
Participants who never received any HBV treatment, will receive peginterferon alfa-2a (180 micrograms [mcg]) subcutaneously once weekly for 48 weeks.
Participants who received conventional interferon treatment and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.
Participants who received lamivudine and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.
Outcomes
Primary Outcome Measures
Percentage of participants with HBV deoxyribonucleic acid (DNA) less than (<) 100,000 copies per milliliters (copies/mL)
Percentage of participants with HBeAg seroconversion
Secondary Outcome Measures
Number of participants who achieved HBV DNA levels below limit of detection
Number of participants with HBsAg loss
Number of participants with both Hepatitis B Surface Antigen (HBsAg) loss and presence of Anti-HBs
Number of participants with alanine aminotransferase (ALT) normalization
Number of participants with combined response (HBV DNA <100,000 copies/mL, HBeAg loss, and ALT normalization)
Incidence of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02604823
Brief Title
A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)
Official Title
Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (Pegasys®) in 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
November 2003 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (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 is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive, interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, 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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
307 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (Naïve Participants)
Arm Type
Experimental
Arm Description
Participants who never received any HBV treatment, will receive peginterferon alfa-2a (180 micrograms [mcg]) subcutaneously once weekly for 48 weeks.
Arm Title
Group B (Conventional Interferon Pretreated Participants)
Arm Type
Experimental
Arm Description
Participants who received conventional interferon treatment and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.
Arm Title
Group C (Lamivudine Pretreated Participants)
Arm Type
Experimental
Arm Description
Participants who received lamivudine and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.
Primary Outcome Measure Information:
Title
Percentage of participants with HBV deoxyribonucleic acid (DNA) less than (<) 100,000 copies per milliliters (copies/mL)
Time Frame
72 weeks
Title
Percentage of participants with HBeAg seroconversion
Time Frame
72 weeks
Secondary Outcome Measure Information:
Title
Number of participants who achieved HBV DNA levels below limit of detection
Time Frame
Weeks 48 and 72
Title
Number of participants with HBsAg loss
Time Frame
Weeks 48 and 72
Title
Number of participants with both Hepatitis B Surface Antigen (HBsAg) loss and presence of Anti-HBs
Time Frame
Weeks 48 and 72
Title
Number of participants with alanine aminotransferase (ALT) normalization
Time Frame
Weeks 48 and 72
Title
Number of participants with combined response (HBV DNA <100,000 copies/mL, HBeAg loss, and ALT normalization)
Time Frame
Weeks 48 and 72
Title
Incidence of adverse events
Time Frame
up to 72 weeks
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 between 18 to 65 years of age
HBeAg-positive chronic HBV
Treatment-naive, or have received and have not responded to or have relapsed on either conventional interferon or lamivudine therapy.
Exclusion Criteria:
Antiviral or interferon-based therapy for chronic HBV within 6 months of enrollment
Co-infection with active hepatitis A, C or D virus or with human immunodeficiency virus (HIV)
Evidence of decompensated liver disease
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 Chair
Facility Information:
City
Beijing
ZIP/Postal Code
100011
Country
China
City
Guangzhou
ZIP/Postal Code
510630
Country
China
City
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)
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