Back to resultsA Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)
Primary Purpose
Hepatitis B, Chronic
Status
Completed
Phase
Phase 4
Locations
Bulgaria
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 18-70 years of age
- Positive test result for HBsAg for >6 months
- Naive to treatment for HBV
- On liver biopsy, liver disease consistent with chronic HBV, with or without compensated cirrhosis
Exclusion Criteria:
- Co-infection with hepatitis A, C or D, or with Human Immunodeficiency Virus (HIV)
- Decompensated liver disease
- Hepatocellular cancer
- Systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal to 6 months before study drug
- Medical condition associated with chronic liver disease
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Peginterferon alfa-2a
Arm Description
Participants received 180 micrograms (uG) of Pegasys (0.5 milliliter [mL] solution) once a week subcutaneously for 48 weeks.
Outcomes
Primary Outcome Measures
Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up
Alanine Transaminase (ALT) Normalization at the End of Follow-Up
Secondary Outcome Measures
Efficacy: Loss of Hepatitis B Virus Antigen ( HBsAg) and Seroconversion at End of Follow-Up
Hepatitis B Virus (HBV) DNA Below the Limit of Quantification At the End of Follow-Up
HBV DNA Suppression <20000 Copies/mL at the End of Treatment
Alanine Transaminase (ALT) Normalization at the End of Treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02570191
Brief Title
A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)
Official Title
An Open-label, Multicenter, National, Not-randomized Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (PEGASYS) in Patients With HBeAg-negative Chronic Hepatitis B
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (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, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 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
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peginterferon alfa-2a
Arm Type
Experimental
Arm Description
Participants received 180 micrograms (uG) of Pegasys (0.5 milliliter [mL] solution) once a week subcutaneously for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
180 uG in 0.5 mL solution administered once weekly for 48 weeks
Primary Outcome Measure Information:
Title
Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up
Time Frame
72 Weeks
Title
Alanine Transaminase (ALT) Normalization at the End of Follow-Up
Time Frame
72 Weeks
Secondary Outcome Measure Information:
Title
Efficacy: Loss of Hepatitis B Virus Antigen ( HBsAg) and Seroconversion at End of Follow-Up
Time Frame
72 Weeks
Title
Hepatitis B Virus (HBV) DNA Below the Limit of Quantification At the End of Follow-Up
Time Frame
72 Weeks
Title
HBV DNA Suppression <20000 Copies/mL at the End of Treatment
Time Frame
48 Weeks
Title
Alanine Transaminase (ALT) Normalization at the End of Treatment
Time Frame
48 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult participants 18-70 years of age
Positive test result for HBsAg for >6 months
Naive to treatment for HBV
On liver biopsy, liver disease consistent with chronic HBV, with or without compensated cirrhosis
Exclusion Criteria:
Co-infection with hepatitis A, C or D, or with Human Immunodeficiency Virus (HIV)
Decompensated liver disease
Hepatocellular cancer
Systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal to 6 months before study drug
Medical condition associated with 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
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
12. IPD Sharing Statement
Learn more about this trial
A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)
We'll reach out to this number within 24 hrs