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

Hepatitis B, Chronic Clinical Trial

Official title:

A Multicenter, Prospective, Non-Interventional Study Evaluating Response Parameters During and After Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734018
• Other study ID #: ML25614
• Status: Completed
• Phase: N/A
• First received: November 21, 2012
• Last updated: November 1, 2016
• Start date: August 2011
• Est. completion date: August 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

This multicenter, prospective, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in routine clinical practice in patients with HBeAg-positive or HBeAg-negative chronic hepatitis B. Eligible patients receiving treatment with Pegasys according to standard of care and the summary od product characteristics/local labelling will be followed for the duration of treatment and up to 2 years of follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• HBeAg-positive or HBeAg-negative serologically proven chronic hepatitis B with or without cirrhosis

• Elevated serum ALT > ULN (upper limit of normal) but </=10 x ULN according to local label

Exclusion Criteria:

• Contra-indications to Pegasys as detailed in the label

• Co-infection with hepatitis A, hepatitis B or HIV

• Concomitant therapy with telbivudine (concomitant peginterferon alfa-2a therapy is contra-indicated according to telbivudine label)

• Pregnant or breastfeeding women

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HBsAg (IU/ml) levels during therapy (up to 48 weeks) and follow-up		from baseline to up to approximately 3 years	No
Primary	Change in HBV DNA (IU/ml) during therapy (up to 48 weeks) and follow-up		from baseline to up to approximately 3 years	No
Secondary	Percentage of patients with sustained immune control (sustained HBV DNA <2000 IU/ml in HBeAg-negative and HBeAg-positive patients or HBeAg seroconversion in HBeAg-positive patients)		approximately 4 years	No
Secondary	Percentage of patients with normalisation of serum alanine transaminase (ALT) levels		approximately 4 years	No
Secondary	Percentage of patients with HBsAg clearance/seroconversion		approximately 4 years	No
Secondary	Safety: Incidence of adverse events		approximately 4 years	No