Overview

This trial is active, not recruiting.

Condition hepatitis b, chronic
Sponsor Hoffmann-La Roche
Start date November 2012
End date April 2017
Trial size 978 participants
Trial identifier NCT01730508, ML28516

Summary

This multicenter, prospective, observational study will evaluate the use in clinical practice and the efficacy and safety of Pegasys (peginterferon alfa-2a) in Chinese patients with HBeAg negative chronic hepatitis B. Patients receiving Pegasys according to the local label will be followed for the duration of their treatment and for one year after cessation of treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation
time frame: approximately 4 years

Secondary Outcomes

Measure
Incidence of suppression of HBV DNA <2000 IU/mL at the end of treatment and 6 months post-treatment
time frame: approximately 4 years
Incidence of HBV DNA undetectable (<400 IU/mL) at the end of treatment and 1 year post-treatment
time frame: approximately 4 years
Incidence of HBsAg loss/seroconversion
time frame: approximately 4 years
Incidence of normalization of serum ALT levels
time frame: approximately 4 years
Dosage/schedule of Pegasys treatment in real-life clinical setting
time frame: approximately 4 years
Clinical/demographic patient characteristics at initiation of treatment
time frame: approximately 4 years
Safety: Incidence of adverse events
time frame: approximately 4 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/= 18 years of age - Treatment with Pegasys according to label and standard clinical practice - HBeAg negative serologically proven chronic hepatitis B with or without cirrhosis - Serum ALT > ULN (upper limit of normal) but /= 2000 IU/mL Exclusion Criteria: - Contraindications to Pegasys as detailed in the label - Co-infection with hepatitis A, hepatitis C or HIV - Pregnant or lactating women - Patients should not receive concomitant therapy with telbivudine

Additional Information

Official title A MULTICENTER, PROSPECTIVE, OBSERVATIONAL, NON-INTERVENTIONAL COHORT STUDY IN CHINESE SUBJECTS WITH HBeAg NEGATIVE CHRONIC HEPATITIS B (CHB) RECEIVING THERAPY WITH PEGINTERFERON ALFA
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.