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

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ClinicalTrials.gov Identifier: NCT01679834
Recruitment Status : Completed
First Posted : September 6, 2012
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease
Hepatitis C, Chronic

Study Type : Observational
Estimated Enrollment : 7500 participants
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
Actual Study Start Date : November 24, 2014
Actual Primary Completion Date : July 14, 2017
Actual Study Completion Date : July 14, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Cohort



Primary Outcome Measures :
  1. Sustained virological response [ Time Frame: 24 weeks after end of treatment ]

Secondary Outcome Measures :
  1. Rapid virological response [ Time Frame: 4 weeks after start of treatment ]
  2. Early Virological Response [ Time Frame: 12 weeks after start of treatment ]
  3. Safety: incidence of adverse events [ Time Frame: up to 24 weeks after end of treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679834


Locations
Germany
Hannover, Germany, 30625
Herne, Germany, 44623
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01679834     History of Changes
Other Study ID Numbers: ML25724
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents