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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Clalit Health Services
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01604291
First received: May 21, 2012
Last updated: August 26, 2014
Last verified: August 2014

May 21, 2012
August 26, 2014
May 2012
September 2015   (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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Correlation between SVR-24 and clinical/demographic baseline values [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Treatment duration [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Dose reductions/treatment discontinuations [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Correlation between dose reductions/treatment interruptions and sustained virological response (SVR) [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events (dual versus triple therapy) [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Rate of treatment-induced anemia (dual versus triple therapy) [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Treatment regimens for HCV treatment induced anemia in routine clinical practice [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Rate of virological relapse [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Chronic hepatitis C patients initiating Pegasys-based treatment

Hepatitis C, Chronic
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
967
September 2015
September 2015   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01604291
ML28268
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Clalit Health Services
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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