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An Observational Cohort Study in Patients With Chronic Hepatitis B Receiving Pegasys

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01011738
First received: November 10, 2009
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

This observational, non-interventional cohort study will evaluate predictors of response in patients with chronic hepatitis B receiving standard of care Pegasys therapy. Efficacy and safety parameters will also be evaluated. Patients included in the study are followed for up to 5 years. Target sample size is <2500.


Condition Intervention
Hepatitis B, Chronic
 Drug: peginterferon alfa-2a [Pegasys]

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Prospective, Observational, Non-Interventional Cohort Study Evaluating On-Treatment Predictors of Response in Subjects With HBeAg Positive and HBeAg Negative Chronic Hepatitis B Receiving Therapy With PEGASYS(R) (Peginterferon Alfa-2a 40KD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • HBsAg clearance [ Time Frame: on treatment and up to 5 years follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • suppression of HBV DNA, HBeAg seroconversion, quantitative HBsAg, serum ALT [ Time Frame: on treatment and up to 5 years follow-up ] [ Designated as safety issue: No ]
  • Safety: incidence of CHB-associated clinical endpoints, serious and non-serious adverse drug reactions [ Time Frame: on treatment and up to 5 years follow-up ] [ Designated as safety issue: No ]

Enrollment: 1849
Study Start Date: April 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort Drug: peginterferon alfa-2a [Pegasys]
As prescribed by physician

  Eligibility

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

Patients with chronic hepatitis C receiving treatment with peginterferon alfa-2a 40KD (Pegasys)

Criteria

Inclusion Criteria:

  • adult patient, >/= 18 years of age
  • chronic hepatitis B
  • treatment with peginterferon alfa-2A

Exclusion Criteria:

  • coinfection with HAV, HCV and HIV
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011738

  Show 230 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: NCT01011738     History of Changes
Other Study ID Numbers: MV22009
Study First Received: November 10, 2009
Last Updated: December 3, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013