An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C
- Conditions
- Hepatitis C, Chronic
- Registration Number
- NCT01604291
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 991
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Viral Response (SVR) at Week 24 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Extended RVR Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group Extended RVR was defined as HCV-RNA \<50 IU/mL at weeks 4 and 12 for participants treated with telaprevir; or at weeks 8 \& 24 for participants treated with boceprevir.
The assessment was performed in participants who received triple therapy in treatment arms 'Peginterferon Alfa-2a + Ribavirin +Telaprevir' and 'Peginterferon Alfa-2a + Ribavirin + Boceprevir'.Time to First Dose Modification of Peginterferon Alfa-2a Week 48 Percentage of Participants With End of Treatment Response (EoT) Week 24 End-of-Treatment (EoT) response was defined as HCV-RNA \<50 IU/mL by the end of treatment.
Treatment Duration Week 48 The average amount of time a treatment was prescribed to participants.
Time to First Dose Modification of Ribavirin Week 48 Percentage of Participants Who Had SVR at Week 24 With Dose Modifications Week 24 Participants with dose modifications who had achieved SVR at Week 24 were reported. Data was collected for all participants who had dose modification of Peginterferon alfa-2a, Ribavirin or Telaprevir/boceprevir in any of the treatment regimen during the study.
Comparison of SVR at Week 24 Week 24 SVR at Week 24 is compared by treatment group, type of infection, prior treatments and genotype.
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 Week 4 RVR was defined as HCV-RNA \<50 IU/mL by Week 4
Time to First Dose Modification of Telaprevir/Boceprevir Week 48 Number of Participants With SVR at Week 24 According to the Demographic Characteristics 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. Number of participants analysed signifies participants who were evaluated for outcome measure. Data for this outcome measure was not summarized for each arm. Hence, data is reported for all participants.
Percentage of Participants With Complete Early Virologic Response (cEVR) Week 12 Complete early virologic response (cEVR) was defined as HCV-RNA \<50 IU/mL by Week 12
Percentage of Participants With Virologic Relapse Week 72 Virologic relapse was defined as detectable HCV-RNA during the treatment-free follow-up period in participants with HCV-RNA \<50 IU/mL at EoT.
Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia Week 48 Percentage of Participants With Adverse Events (AEs) Week 48 Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Safety analysis included 2 additional participants in arm 'Peginterferon Alfa-2a + Ribavirin + Telaprevir'. The safety parameters were analyzed by the treatment actually received by the participants.Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia Week 48
Trial Locations
- Locations (21)
Tel-Aviv Sourasky Medical Center; Liver Unit
🇮🇱Tel Aviv, Israel
Haemek Hospital; Gastroenterology
🇮🇱Afula, Israel
Barzilai MC; Gastroenterology
🇮🇱Ashkelon, Israel
Carmel Hospital; Liver Unit
🇮🇱Haifa, Israel
Soroka Medical Center; Gastroenterology
🇮🇱Beer Sheva, Israel
Rambam Medical Center; Gastroenterology - Liver Unit
🇮🇱Haifa, Israel
Bnei-Zion Medical Center; Gastroenterology
🇮🇱Haifa, Israel
Hillel Yaffe Hospital; Gastroenterology
🇮🇱Hadera, Israel
Wolfson Hospital; Gastroenterology Unit
🇮🇱Holon, Israel
Shaare Zedek Hospital Liver Unit; Liver Unit
🇮🇱Jerusalem, Israel
Meir Medical Center; Liver Unit
🇮🇱Kfar Saba, Israel
Hadassah Hospital; Liver Unit
🇮🇱Jerusalem, Israel
Western Galilee Hospital - Nahariya
🇮🇱Nahariya, Israel
Holy Family Medical Center; Liver Unit
🇮🇱Nazareth, Israel
Beilinson-Rabin Liver Unit; Liver Unit
🇮🇱Petah Tiqwa, Israel
Kaplan Medical Center; Gastroenterology Unit
🇮🇱Rehovot, Israel
Hasharon Mc; Gastroenterology
🇮🇱Petach Tikva, Israel
Sheba Medical Center; Tel Hashomer
🇮🇱Ramat Gan, Israel
Rebecca Sieff Medical Center; Liver Unit
🇮🇱Safed, Israel
Assaf Harofeh; Gastroenterology
🇮🇱Zerifin, Israel
Poria Hospital; Gastroenterology
🇮🇱Tiberias, Israel