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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Chronic
Hepatitis B
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 September 18, 2014