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

Hepatitis B, Chronic Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667432
• Other study ID #: ML25626
• Status: Completed
• Phase: N/A
• First received: August 15, 2012
• Last updated: November 3, 2015
• Start date: July 2011
• Est. completion date: August 2014

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• Peginterferon alfa-2a
Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml		approximately 3 years	No
Primary	In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive		approximately 3 years	No
Secondary	Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment	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.	At the end of treatment (Week 24)	No
Secondary	HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative		approximately 3 years	No
Secondary	Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients		approximately 3 years	No
Secondary	Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients		approximately 3 years	Yes
Secondary	Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio		approximately 3 years	No
Secondary	Safety: Incidence of Adverse Events		approximately 3 years	No