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
1 other identifier
observational
991
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2012
Typical duration for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2012
CompletedFirst Posted
Study publicly available on registry
May 23, 2012
CompletedStudy Start
First participant enrolled
May 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2016
CompletedResults Posted
Study results publicly available
March 14, 2019
CompletedMarch 14, 2019
November 1, 2018
3.7 years
May 21, 2012
July 5, 2017
November 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Sustained Viral Response (SVR) at Week 24
The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels \< 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion.
Week 24
Secondary Outcomes (15)
Comparison of SVR at Week 24
Week 24
Number of Participants With SVR at Week 24 According to the Demographic Characteristics
Week 24
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
Week 4
Percentage of Participants With Extended RVR
Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group
Percentage of Participants With Complete Early Virologic Response (cEVR)
Week 12
- +10 more secondary outcomes
Study Arms (1)
Cohort
Eligibility Criteria
Chronic hepatitis C patients initiating Pegasys-based treatment
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Clalit Health Servicescollaborator
Study Sites (21)
Haemek Hospital; Gastroenterology
Afula, 18101, Israel
Barzilai MC; Gastroenterology
Ashkelon, 78278, Israel
Soroka Medical Center; Gastroenterology
Beersheba, 84105, Israel
Hillel Yaffe Hospital; Gastroenterology
Hadera, 38100, Israel
Rambam Medical Center; Gastroenterology - Liver Unit
Haifa, 31096, Israel
Bnei-Zion Medical Center; Gastroenterology
Haifa, 33394, Israel
Carmel Hospital; Liver Unit
Haifa, 34362, Israel
Wolfson Hospital; Gastroenterology Unit
Holon, 58100, Israel
Shaare Zedek Hospital Liver Unit; Liver Unit
Jerusalem, 91031, Israel
Hadassah Hospital; Liver Unit
Jerusalem, 91120, Israel
Meir Medical Center; Liver Unit
Kfar Saba, 44281, Israel
Western Galilee Hospital - Nahariya
Nahariya, 22100, Israel
Holy Family Medical Center; Liver Unit
Nazareth, Israel
Beilinson-Rabin Liver Unit; Liver Unit
Petah Tikva, Israel
Hasharon Mc; Gastroenterology
Petah Tikva, Israel
Sheba Medical Center; Tel Hashomer
Ramat Gan, 5262100, Israel
Kaplan Medical Center; Gastroenterology Unit
Rehovot, 76100, Israel
Rebecca Sieff Medical Center; Liver Unit
Safed, 13110, Israel
Tel-Aviv Sourasky Medical Center; Liver Unit
Tel Aviv, 6423906, Israel
Poria Hospital; Gastroenterology
Tiberias, Israel
Assaf Harofeh; Gastroenterology
Ẕerifin, 6093000, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2012
First Posted
May 23, 2012
Study Start
May 28, 2012
Primary Completion
February 10, 2016
Study Completion
February 10, 2016
Last Updated
March 14, 2019
Results First Posted
March 14, 2019
Record last verified: 2018-11