A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B
Baltic Post-marketing Program of PEGASYS (Peg Interferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B
1 other identifier
interventional
39
3 countries
9
Brief Summary
This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive chronic Hepatitis B virus (HBV). All participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneously once weekly. Following 48 weeks of 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 less than 100 participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2007
Typical duration for phase_4
9 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
First Submitted
Initial submission to the registry
February 15, 2007
CompletedFirst Posted
Study publicly available on registry
February 16, 2007
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
October 24, 2016
CompletedOctober 24, 2016
August 1, 2016
3.2 years
February 15, 2007
August 31, 2016
August 31, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL)
HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg positive participants were defined as those who had HBV DNA greater than (\>) 1,00,000 copies/mL at baseline. This outcome measured the number of participants with HBV-DNA levels \< 1,00,000 copies/mL at Week 72, who were defined as HBeAg positive at baseline.
Week 72
Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL
HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease. HBeAg negative participants were defined as those who had HBV DNA \>10,000 copies/mL at baseline. This outcome measured the number of participants with HBV DNA \<10,000 copies/mL at Week 72, who were defined as HBeAg negative at baseline.
Week 72
Secondary Outcomes (6)
Number of Participants With HBV-DNA < 400 Copies/mL
Week 72
Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants
Week 48 and Week 72
Percentage of Anti-HBs Positive Participants
Week 48 and Week 72
Mean Alanine Aminotransferase (ALT) Concentrations
Week 48 and Week 72
Percentage of HBeAg Negative Participants
Week 48 and Week 72
- +1 more secondary outcomes
Study Arms (1)
Peginterferon Alfa-2a
EXPERIMENTALParticipants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
Interventions
180 mcg subcutaneously once per week for 48 weeks.
Eligibility Criteria
You may qualify if:
- Adult participants, 18-70 years of age;
- HBeAg positive, Hepatitis B surface antigen (HBsAg) positive for greater than or equal to 6 months;
- anti-HBs negative;
- Hepatitis B virus deoxyribonucleic acid (HBV DNA) greater than 5,00,000 copies/milliliters.
You may not qualify if:
- Previous antiviral or interferon-based therapy for chronic hepatitis B;
- Evidence of decompensated liver disease;
- Chronic liver disease other than viral hepatitis;
- Co-infection with active hepatitis A, C or D virus;
- Co-infection with human immunodeficiency virus.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Unknown Facility
Tallinn, 10138, Estonia
Unknown Facility
Tallinn, 10617, Estonia
Unknown Facility
Tartu, 51014, Estonia
Unknown Facility
Riga, 1006, Latvia
Unknown Facility
Kaunas, 47144, Lithuania
Unknown Facility
Kaunas, 50009, Lithuania
Unknown Facility
Klaipėda, 92288, Lithuania
Unknown Facility
Vilnius, 08117, Lithuania
Unknown Facility
Vilnius, 08661, Lithuania
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2007
First Posted
February 16, 2007
Study Start
March 1, 2007
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
October 24, 2016
Results First Posted
October 24, 2016
Record last verified: 2016-08