An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Biological: Peginterferon alfa-2a

• Registration Number: NCT01667432
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-08
• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-17
• Primary Completion: 2014-08-12
• Study Completion: 2014-08-12
• Results First Submitted: 2015-10-01
• Results First Submitted QC: 2015-11-03
• Results First Posted: 2015-12-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-10
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Peginterferon alfa-2a	Peginterferon alfa-2a	Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study	At the end of the study (Week 36)	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).
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 Outcome Measures

Name	Time	Method
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
Safety: Incidence of Adverse Events	approximately 3 years
HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative	approximately 3 years
Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment	At the end of treatment (Week 24)	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) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative.
Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients	approximately 3 years

Trial Locations

Locations (9)

Mhat - Pleven; Clinic of Gastroenterology; 🇧🇬 Pleven, Bulgaria

Umhat St. Georgi; Clinical of Gastroenterology; 🇧🇬 Plovdiv, Bulgaria

MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases; 🇧🇬 Sofia, Bulgaria

UMHAT Alexandrovska EAD; Gastroenterology; 🇧🇬 Sofia, Bulgaria

Military Medical Academy; Gastroenterology; 🇧🇬 Sofia, Bulgaria

Mhat Queenjoanna; Clinic of Gastroenterology; 🇧🇬 Sofia, Bulgaria

Mhat St. Ivan Rilski; Clinic of Gastroenterology; 🇧🇬 Sofia, Bulgaria

Mhat St. Zagora; Clinical of Gastroenterology; 🇧🇬 Stara Zagora, Bulgaria

Mhat Sveta Marina; Clinic of Gastroenterology; 🇧🇬 Varna, Bulgaria