Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01679834
First received: September 3, 2012
Last updated: March 2, 2015
Last verified: March 2015
  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:


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 ]

Enrollment: 6224
Study Start Date: December 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
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: NCT01679834

Locations
Germany
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: March 2, 2015
Health Authority: Germany: BfArM (Federal Institute for Drugs and Medical Devices)

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

ClinicalTrials.gov processed this record on March 02, 2015