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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.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01730508
First received: November 15, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition
Hepatitis B, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2000
Study Start Date: November 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730508

Contacts
Contact: Please reference Study ID Number: ML28516 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 54 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01730508     History of Changes
Other Study ID Numbers: ML28516
Study First Received: November 15, 2012
Last Updated: May 7, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013