An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B
A Multicenter, Prospective, Observational, Non-interventional Study Evaluating On-treatment Predictors of Response in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B Receiving Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD)
1 other identifier
observational
141
1 country
9
Brief Summary
This prospective, multicenter, observational study will evaluate on-treatment predictors of response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving treatment with peginterferon alfa-2a (PEGASYS®) in accordance with local labeling and the summary of product characteristics. Data will be collected from patients for the duration of their treatment and for up to 24 weeks thereafter.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2011
Typical duration for all trials
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
Study Start
First participant enrolled
July 8, 2011
CompletedFirst Submitted
Initial submission to the registry
August 15, 2012
CompletedFirst Posted
Study publicly available on registry
August 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2014
CompletedResults Posted
Study results publicly available
December 7, 2015
CompletedApril 10, 2017
March 1, 2017
3.1 years
August 15, 2012
October 1, 2015
March 10, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study
Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml).
At the end of the study (Week 36)
Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml
approximately 3 years
In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive
approximately 3 years
Secondary Outcomes (6)
Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment
At the end of treatment (Week 24)
HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative
approximately 3 years
Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients
approximately 3 years
Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients
approximately 3 years
Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio
approximately 3 years
- +1 more secondary outcomes
Study Arms (1)
Peginterferon alfa-2a
Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
Interventions
Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes.
Eligibility Criteria
Patients with chronic hepatitis B on treatment with PEGASYS.
You may qualify if:
- Adult patients ≥ 18 years of age.
- Hepatitis B envelope antigen (HBeAg) positive or HBeAg negative hepatitis B with or without cirrhosis.
- Elevated alanine aminotransferase (ALT) \> upper limit of normal (ULN) but ≤ 10 x ULN according to local label.
You may not qualify if:
- Contraindications to peginterferon alfa-2a (PEGASYS®) as detailed in the label.
- Co-infection with hepatitis A, hepatitis C, or human immunodeficiency virus (HIV).
- Concomitant treatment with telbivudine.
- Pregnant or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Mhat - Pleven; Clinic of Gastroenterology
Pleven, 5800, Bulgaria
Umhat St. Georgi; Clinical of Gastroenterology
Plovdiv, 4002, Bulgaria
MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases
Sofia, 1407, Bulgaria
UMHAT Alexandrovska EAD; Gastroenterology
Sofia, 1431, Bulgaria
Mhat Queenjoanna; Clinic of Gastroenterology
Sofia, 1527, Bulgaria
Military Medical Academy; Gastroenterology
Sofia, 1606, Bulgaria
Mhat St. Ivan Rilski; Clinic of Gastroenterology
Sofia, 1612, Bulgaria
Mhat St. Zagora; Clinical of Gastroenterology
Stara Zagora, 6000, Bulgaria
Mhat Sveta Marina; Clinic of Gastroenterology
Varna, 9010, Bulgaria
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
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2012
First Posted
August 17, 2012
Study Start
July 8, 2011
Primary Completion
August 12, 2014
Study Completion
August 12, 2014
Last Updated
April 10, 2017
Results First Posted
December 7, 2015
Record last verified: 2017-03