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

NCT01604291

CompletedN/A

Sponsor: Hoffmann-La Roche

Conditions: Hepatitis C, Chronic

Countries: Israel

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (21)
  • Afula, Israel
  • Ashkelon, Israel
  • Beersheba, Israel
  • Hadera, Israel
  • Haifa, Israel
  • Haifa, Israel
  • Haifa, Israel
  • Holon, Israel
  • Jerusalem, Israel
  • Jerusalem, Israel
  • Kfar Saba, Israel
  • Nahariya, Israel
  • Nazareth, Israel
  • Petah Tikva, Israel
  • Petah Tikva, Israel
  • Ramat Gan, Israel
  • Rehovot, Israel
  • Safed, Israel
  • Tel Aviv, Israel
  • Tiberias, Israel
  • Ẕerifin, Israel