A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection.

Hepatitis C, Chronic Clinical Trial

Official title:

A Randomized, Double-blinded Study to Evaluate the Safety and Effect on Sustained Virological Response of HCV Polymerase Inhibitor Pro-drug in Combination With PEGASYS Plus Copegus, Compared With the Currently Approved Combination of PEGASYS Plus Copegus, in Treatment-naïve Patients With Chronic he

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00517439
• Other study ID #: NV19865
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2007
• Last updated: November 1, 2016
• Start date: December 2007
• Est. completion date: January 2010

Study information

• Verified date: November 2016
• 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 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or 180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks. Group 7 will receive standard of care (SOC) for 48 weeks. There will be a 24 week period of treatment-free follow-up for all treatment groups. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• adult patients, 18-65 years of age;

• chronic hepatitis C, genotype 1;

• chronic liver disease consistent with CHC;

• compensated liver disease.

Exclusion Criteria:

• infection with any HCV genotype other than genotype 1;

• previous treatment for CHC;

• medical condition associated with chronic liver disease other than CHC;

• HIV, hepatitis A, hepatitis B infection.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Copegus
1000/1200mg po daily for 24 weeks
• Pegasys
180 micrograms sc weekly for 24 weeks
• Pegasys
90 micrograms sc weekly for 24 weeks
• RO4588161
1000mg po bid for 24 weeks
• RO4588161
500mg po bid for 24 weeks
• RO4588161
1500mg po bid for 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  France,  Germany,  Italy,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response (SVR)		24 weeks post treatment end (ie weeks 48 or 72)	No
Secondary	Virological response over time		Throughout study	No
Secondary	SVR		12 weeks post treatment end (ie weeks 36 or 60)	No
Secondary	Relapse rate		End of treatment (ie weeks 24 or 48)	No
Secondary	Adverse events (AEs), laboratory parameters.		Throughout treatment	No