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An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C

This study has been completed.
Sponsor:
Collaborator:
Clalit Health Services
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01604291
First received: May 21, 2012
Last updated: February 15, 2017
Last verified: February 2017

May 21, 2012
February 15, 2017
May 2012
February 2016   (Final data collection date for primary outcome measure)
Sustained Virological Response (SVR)-24 rate: Percentage of patients with HCV RNA <50 IU/mL at 24 weeks post completion of treatment [ Time Frame: approximately 4.5 years ]
Same as current
Complete list of historical versions of study NCT01604291 on ClinicalTrials.gov Archive Site
  • Dual versus triple Pegasys-based therapy: SVR-24 rates [ Time Frame: approximately 4.5 years ]
  • Correlation between SVR-24 and clinical/demographic baseline values [ Time Frame: approximately 4.5 years ]
  • Predictive value of on-treatment factors (RVR, eRVR, EVR, EOT) on virological response (HCV-RNA <50 IU/mL): Percentage of patients with rapid/rapid extended/early/end of treatment response [ Time Frame: approximately 4.5 years ]
  • Treatment duration [ Time Frame: approximately 4.5 years ]
  • Dose reductions/treatment discontinuations [ Time Frame: approximately 4.5 years ]
  • Correlation between dose reductions/treatment interruptions and sustained virological response (SVR) [ Time Frame: approximately 4.5 years ]
  • Safety: Incidence of adverse events (dual versus triple therapy) [ Time Frame: approximately 4.5 years ]
  • Rate of treatment-induced anemia (dual versus triple therapy) [ Time Frame: approximately 4.5 years ]
  • Treatment regimens for HCV treatment induced anemia in routine clinical practice [ Time Frame: approximately 4.5 years ]
  • Rate of virological relapse [ Time Frame: approximately 4.5 years ]
Same as current
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An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C
Multi-Center, Non-Interventional Study, on the Efficacy of Dual and Triple Therapies Based on Pegylated Interferon Alfa-2a for the Treatment of Chronic Hepatitis C Patients
This multi-center, observational study will evaluate the efficacy and safety of dual and triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to 24 weeks of follow-up.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Chronic hepatitis C patients initiating Pegasys-based treatment
Hepatitis C, Chronic
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Cohort
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
959
February 2016
February 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Chronic hepatitis C (all genotypes, naïve or treatment experienced, HCV mono-infected or HCV-HIV co-infected)
  • Receiving either dual therapy (Pegasys plus ribavirin) or triple therapy (Pegasys plus ribavirin plus telaprevir/boceprevir)
  • No contra-indications to Pegasys and ribavirin therapy or to treatment regimen containing protease inhibitor (telaprevir or boceprevir) as detailed in local Prescribing Information
  • Quantitative serum HCV RNA by PCR test before initiation of treatment

Exclusion Criteria:

  • Hepatitis A/B co-infection
  • Evidence of severe illness, active malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • Pregnant or breast-feeding women
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01604291
ML28268
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Hoffmann-La Roche
Hoffmann-La Roche
Clalit Health Services
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP