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An Observational Study of Pegasys in Dual- or Triple-Therapy in Patients With Chronic Hepatitis C

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:
NCT01679834
First received: September 3, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This multicenter, observational study will assess the efficacy and the safety of Pegasys (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis C. Patients will receive Pegasys and/or ribavirin and/or a protease inhibitor according to local guidelines. Data will be collected for 96 weeks.


Condition
Hepatitis C, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Roche Project in Cooperation With the Bng (Association of German Resident Gastroenterologists) for Quality Assurance in the Dual- or Triple-therapy of Chronic Hepatitis C With Peg-(40kd)-Interferon Alfa 2a (Pegasys) at Hepatology Centers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained virological response [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rapid virological response [ Time Frame: 4 weeks after start of treatment ] [ Designated as safety issue: No ]
  • Early Virological Response [ Time Frame: 12 weeks after start of treatment ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: up to 24 weeks after end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 7500
Study Start Date: October 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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

Patients with chronic hepatitis C infection

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Diagnosis of chronic hepatitis C
  • Patients receiving treatment with Pegasys and/or Copegus (ribavirin) and/or a protease inhibitor according to local label

Exclusion Criteria:

  • Contraindications against Pegasys or Copegus
  • Not willing or unable to sign written informed consent form
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679834

Contacts
Contact: Please reference Study ID Number: ML25724 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Germany
Recruiting
Herne, Germany, 44623
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: NCT01679834     History of Changes
Other Study ID Numbers: ML25724
Study First Received: September 3, 2012
Last Updated: May 7, 2013
Health Authority: Germany: BfArM (Federal Institute for Drugs and Medical Devices)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 19, 2013