A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)
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
1 other identifier
interventional
60
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2004
Typical duration for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
October 7, 2015
CompletedNovember 2, 2016
November 1, 2016
2.3 years
October 5, 2015
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up
72 Weeks
Alanine Transaminase (ALT) Normalization at the End of Follow-Up
72 Weeks
Secondary Outcomes (4)
Efficacy: Loss of Hepatitis B Virus Antigen ( HBsAg) and Seroconversion at End of Follow-Up
72 Weeks
Hepatitis B Virus (HBV) DNA Below the Limit of Quantification At the End of Follow-Up
72 Weeks
HBV DNA Suppression <20000 Copies/mL at the End of Treatment
48 Weeks
Alanine Transaminase (ALT) Normalization at the End of Treatment
48 Weeks
Study Arms (1)
Peginterferon alfa-2a
EXPERIMENTALParticipants received 180 micrograms (uG) of Pegasys (0.5 milliliter \[mL\] solution) once a week subcutaneously for 48 weeks.
Interventions
180 uG in 0.5 mL solution administered once weekly for 48 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Pleven, 5800, Bulgaria
Unknown Facility
Plovdiv, 4002, Bulgaria
Unknown Facility
Sofia, 1233, Bulgaria
Unknown Facility
Sofia, 1431, Bulgaria
Unknown Facility
Sofia, 1527, Bulgaria
Unknown Facility
Sofia, 1606, Bulgaria
Unknown Facility
Sofia, 1612, Bulgaria
Unknown Facility
Stara Zagora, 6000, Bulgaria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2015
First Posted
October 7, 2015
Study Start
November 1, 2004
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
November 2, 2016
Record last verified: 2016-11