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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01734018

Enrollment

Registered

2012-11-27

Start date

2011-08-31

Completion date

2012-08-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in HBsAg (IU/ml) levels during therapy (up to 48 weeks) and follow-up	from baseline to up to approximately 3 years
Change in HBV DNA (IU/ml) during therapy (up to 48 weeks) and follow-up	from baseline to up to approximately 3 years

Secondary

Measure	Time frame
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
Percentage of patients with normalisation of serum alanine transaminase (ALT) levels	approximately 4 years
Percentage of patients with HBsAg clearance/seroconversion	approximately 4 years
Safety: Incidence of adverse events	approximately 4 years

Countries

Germany

Outcome results