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An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C

NCT01447446 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4442

Last updated 2017-03-30

Study results available
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Summary

This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of pegylated interferon alfa (peginterferon alfa) (e.g. Pegasys) plus ribavirin and treatment regimens containing direct-acting antivirals in participants with chronic hepatitis C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be collected from participants receiving treatment according to current Summary of Product Characteristics (SPC) and local labeling for the duration of their treatment and a 24-week follow-up.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Peg-IFN Alfa-2a

Peg-IFN Alfa-2a according to standard of care and in line with local labeling.

DRUG

Peg-IFN Alfa-2b

Peg-IFN Alfa-2b according to standard of care and in line with local labeling.

DRUG

Ribavirin

Ribavirin according to standard of care and in line with local labeling.

DRUG

Boceprevir

Boceprevir according to standard of care and in line with local labeling.

DRUG

Telaprevir

Telaprevir according to standard of care and in line with local labeling.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Belgium
  • Egypt
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Kuwait
  • Lebanon
  • Morocco
  • North Macedonia
  • Oman
  • Pakistan
  • Portugal
  • Qatar
  • Romania
  • Saudi Arabia
  • Serbia
  • Sweden
  • Switzerland
  • Syria
  • Taiwan
  • Turkey (Türkiye)
  • United Arab Emirates
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01447446 on ClinicalTrials.gov