REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy

Hepatitis C, Chronic Clinical Trial

Official title:

A Randomized, Open-label Study of the Effect of PEGASYS Combined With Ribavirin on Sustained Virologic Response in Patients With Chronic Hepatitis C Who Did Not Respond to Previous Pegintron/Ribavirin Combination Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00087646
• Other study ID #: MV17150
• Status: Completed
• Phase: Phase 4
• First received: July 12, 2004
• Last updated: December 10, 2015
• Start date: September 2003
• Est. completion date: May 2008

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 948
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients >=18 years of age;

• CHC infection;

• liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;

• use of 2 forms of contraception during study and 6 months after the study in both men and women;

• Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin combination therapy given for >=12 weeks.

Exclusion Criteria:

• women who are pregnant or breastfeeding;

• male partners of women who are pregnant;

• conditions associated with decompensated liver disease;

• other forms of liver disease, including liver cancer;

• human immunodeficiency virus infection.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ribavirin
1000/1200mg po daily for 72 weeks
• Ribavirin
1000/1200mg po daily for 48 weeks
• peginterferon alfa-2a [Pegasys]
360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 60 weeks
• peginterferon alfa-2a [Pegasys]
360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 36 weeks.
• peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 72 weeks
• peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Canada,  France,  Germany,  Greece,  Italy,  Portugal,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Sustained Virological Response Rate	Sustained Virological Response (SVR) was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.	Up to 72 weeks (Group A) and 48 weeks (Group D)	No
Secondary	Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D)	SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.	At Week 48 and Week 72	No
Secondary	Number of Participants With Sustained Virological Response (Groups A + C vs Groups B + D)	SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.	At Week 48 and Week 72	No
Secondary	Percentage of Participants With Undetectable HCV-RNA	The percentage of participants with a undetectable HCV RNA 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 IU/mL measured >= 20 weeks after treatment end, ie, >=140 days after treatment end) are reported.; End-of-treatment (EOT) virological response is defined as last HCV RNA measurement that is not detectable (<50 IU/mL) at study day of last dose of study medication (+/- 28 days).	At Week 12, 24, 48 and EOT	No
Secondary	Percentage of Participants With >=2log Drop in HCV-RNA	Reduction in HCV-RNA titers of at least 2 log10 after 12/24 weeks of study treatment (i.e. 99% reduction of viral load) was analyzed. Percentage of participants with at least a 2 log10 drop of HCV-RNA at study week 12 and 24 (lower limit of quantitation 600 IU/mL) as compared to baseline or non-detectable HCV-RNA (lower limit of detection 50 IU/mL) were reported.	At Week 12 and 24	No
Secondary	Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D)	The mean change from baseline in HCV RNA level (reduction in viral load) at Week 12 and 24 were determined. HCV RNA result were not detectable (<50 IU/ML) and not quantifiable (<600 IU/ML). Baseline value were assessed on Day 1 before the administration of the first dose of study drug.	At Week 12 and 24	No
Secondary	Percentage of Participants With Maintenance of Actual End-of-Treatment Virological Response	Maintenance of end-of-treatment virological response was assessed based on all participants treated and according to the actual treatment period (backward imputation method). The percentage of participants who maintained their end-of-treatment virological response was determined. Maintenance of actual end-of-treatment virological response was calculated by dividing the number of participants with a virological response both at the end of the actual untreated follow-up period and at the end of the actual treatment period by the number of participants with a virological response at the actual end of treatment.	Week 96 (Group A and C) and Week 72 (Group B and D)	No
Secondary	Percentage of Participants With Relapse After End of Treatment	The percentage of participants who relapsed (loss of response) after having achieved a virological response at the end of treatment was determined.	Week 96 (Group A and C) and Week 72 (Group B and D)	No

External Links

•   This is a full publication titled Re-treatment of Patients With Chronic Hepatitis C Who Do Not Respond to Peginterferon- alfa2b, A Randomized Trial