Clinical trial NCT01604291: An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Clalit Health Services
First posted: 2012-05-23
Enrollment: 991
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic hepatitis C patients initiating Pegasys-based treatment

Brief summary: 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 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

Primary outcomes:
measure: Percentage of Participants With Sustained Viral Response (SVR) at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Comparison of SVR at Week 24
timeFrame: Week 24
measure: Number of Participants With SVR at Week 24 According to the Demographic Characteristics
timeFrame: Week 24
measure: Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
timeFrame: Week 4
measure: Percentage of Participants With Extended RVR
timeFrame: Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group
measure: Percentage of Participants With Complete Early Virologic Response (cEVR)
timeFrame: Week 12
measure: Percentage of Participants With End of Treatment Response (EoT)
timeFrame: Week 24
measure: Percentage of Participants With Virologic Relapse
timeFrame: Week 72
measure: Treatment Duration
timeFrame: Week 48
measure: Time to First Dose Modification of Peginterferon Alfa-2a
timeFrame: Week 48
measure: Time to First Dose Modification of Ribavirin
timeFrame: Week 48
measure: Time to First Dose Modification of Telaprevir/Boceprevir
timeFrame: Week 48
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Week 48
measure: Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia
timeFrame: Week 48
measure: Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia
timeFrame: Week 48
measure: Percentage of Participants Who Had SVR at Week 24 With Dose Modifications
timeFrame: Week 24
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Hospital; Gastroenterology
city: Ashkelon
country: Israel
facility: Barzilai MC; Gastroenterology
city: Beer Sheva
country: Israel
facility: Soroka Medical Center; Gastroenterology
city: Hadera
country: Israel
facility: Hillel Yaffe Hospital; Gastroenterology
city: Haifa
country: Israel
facility: Rambam Medical Center; Gastroenterology - Liver Unit
city: Haifa
country: Israel
facility: Bnei-Zion Medical Center; Gastroenterology
city: Haifa
country: Israel
facility: Carmel Hospital; Liver Unit
city: Holon
country: Israel
facility: Wolfson Hospital; Gastroenterology Unit
city: Jerusalem
country: Israel
facility: Shaare Zedek Hospital Liver Unit; Liver Unit
city: Jerusalem
country: Israel
facility: Hadassah Hospital; Liver Unit
city: Kfar Saba
country: Israel
facility: Meir Medical Center; Liver Unit
city: Nahariya
country: Israel
facility: Western Galilee Hospital - Nahariya
city: Nazareth
country: Israel
facility: Holy Family Medical Center; Liver Unit
city: Petach Tikva
country: Israel
facility: Hasharon Mc; Gastroenterology
city: Petah Tiqwa
country: Israel
facility: Beilinson-Rabin Liver Unit; Liver Unit
city: Ramat Gan
country: Israel
facility: Sheba Medical Center; Tel Hashomer
city: Rehovot
country: Israel
facility: Kaplan Medical Center; Gastroenterology Unit
city: Safed
country: Israel
facility: Rebecca Sieff Medical Center; Liver Unit
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center; Liver Unit
city: Tiberias
country: Israel
facility: Poria Hospital; Gastroenterology
city: Zerifin
country: Israel
facility: Assaf Harofeh; Gastroenterology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: