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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604291
• Other study ID #: ML28268
• Status: Completed
• Start date: May 28, 2012
• Est. completion date: February 10, 2016

Study information

• Verified date: November 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 991
• Est. completion date: February 10, 2016
• Est. primary completion date: February 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Israel	Haemek Hospital; Gastroenterology	Afula
Israel	Barzilai MC; Gastroenterology	Ashkelon
Israel	Soroka Medical Center; Gastroenterology	Beer Sheva
Israel	Hillel Yaffe Hospital; Gastroenterology	Hadera
Israel	Bnei-Zion Medical Center; Gastroenterology	Haifa
Israel	Carmel Hospital; Liver Unit	Haifa
Israel	Rambam Medical Center; Gastroenterology - Liver Unit	Haifa
Israel	Wolfson Hospital; Gastroenterology Unit	Holon
Israel	Hadassah Hospital; Liver Unit	Jerusalem
Israel	Shaare Zedek Hospital Liver Unit; Liver Unit	Jerusalem
Israel	Meir Medical Center; Liver Unit	Kfar Saba
Israel	Western Galilee Hospital - Nahariya	Nahariya
Israel	Holy Family Medical Center; Liver Unit	Nazareth
Israel	Hasharon Mc; Gastroenterology	Petach Tikva
Israel	Beilinson-Rabin Liver Unit; Liver Unit	Petah Tiqwa
Israel	Sheba Medical Center; Tel Hashomer	Ramat Gan
Israel	Kaplan Medical Center; Gastroenterology Unit	Rehovot
Israel	Rebecca Sieff Medical Center; Liver Unit	Safed
Israel	Tel-Aviv Sourasky Medical Center; Liver Unit	Tel Aviv
Israel	Poria Hospital; Gastroenterology	Tiberias
Israel	Assaf Harofeh; Gastroenterology	Zerifin

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of SVR at Week 24	SVR at Week 24 is compared by treatment group, type of infection, prior treatments and genotype.	Week 24
Secondary	Number of Participants With SVR at Week 24 According to the Demographic Characteristics	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.	Week 24
Secondary	Percentage of Participants With Rapid Virologic Response (RVR) at Week 4	RVR was defined as HCV-RNA <50 IU/mL by Week 4	Week 4
Secondary	Percentage of Participants With Extended RVR	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'.	Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group
Secondary	Percentage of Participants With Complete Early Virologic Response (cEVR)	Complete early virologic response (cEVR) was defined as HCV-RNA <50 IU/mL by Week 12	Week 12
Secondary	Percentage of Participants With End of Treatment Response (EoT)	End-of-Treatment (EoT) response was defined as HCV-RNA <50 IU/mL by the end of treatment.	Week 24
Secondary	Percentage of Participants With Virologic Relapse	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.	Week 72
Secondary	Treatment Duration	The average amount of time a treatment was prescribed to participants.	Week 48
Secondary	Time to First Dose Modification of Peginterferon Alfa-2a		Week 48
Secondary	Time to First Dose Modification of Ribavirin		Week 48
Secondary	Time to First Dose Modification of Telaprevir/Boceprevir		Week 48
Secondary	Percentage of Participants With Adverse Events (AEs)	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.	Week 48
Secondary	Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia		Week 48
Secondary	Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia		Week 48
Secondary	Percentage of Participants Who Had SVR at Week 24 With Dose Modifications	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.	Week 24