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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01730508
First received: November 15, 2012
Last updated: November 10, 2014
Last verified: November 2014

November 15, 2012
November 10, 2014
November 2012
December 2016   (final data collection date for primary outcome measure)
Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01730508 on ClinicalTrials.gov Archive Site
  • Incidence of suppression of HBV DNA <2000 IU/mL at the end of treatment and 6 months post-treatment [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Incidence of HBV DNA undetectable (<400 IU/mL) at the end of treatment and 1 year post-treatment [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Incidence of HBsAg loss/seroconversion [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Incidence of normalization of serum ALT levels [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Dosage/schedule of Pegasys treatment in real-life clinical setting [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Clinical/demographic patient characteristics at initiation of treatment [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
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An Observational Study of Pegasys (Peginterferon Alfa-2a) in Chinese Patients With HBeAg Negative Chronic Hepatitis B
A MULTICENTER, PROSPECTIVE, OBSERVATIONAL, NON-INTERVENTIONAL COHORT STUDY IN CHINESE SUBJECTS WITH HBeAg NEGATIVE CHRONIC HEPATITIS B (CHB) RECEIVING THERAPY WITH PEGINTERFERON ALFA

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Not Provided
Probability Sample

Chinese patients with HBeAg negative chronic hepatitis B receiving treatment with Pegasys

Hepatitis B, Chronic
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
December 2016
December 2016   (final data collection date for primary outcome measure)

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 </= 10 x ULN
  • HBV DNA >/= 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
Both
18 Years and older
No
Contact: Reference Study ID Number: ML28516 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
China
 
NCT01730508
ML28516
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP