NCT00517439|CompletedPhase 2

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.

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

Hoffmann-La Roche ClinicalTrials.gov

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1 other identifier

NV19865

Study Type

interventional

Target

516

Locations

8 countries

Sites

Timeline

RegisteredAug 2007

StartedDec 2007

CompletionJan 2010

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

516

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Dec 2007

Geographic Reach

8 countries

62 active sites

Status

completed

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

2.1 years study duration

First Submitted

Initial submission to the registry

August 16, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2007

Completed

4 months until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed

Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.1 years

First QC Date

August 16, 2007

Last Update Submit

November 1, 2016

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

Sustained virological response (SVR)
24 weeks post treatment end (ie weeks 48 or 72)

Secondary Outcomes (4)

Virological response over time
Throughout study
SVR
12 weeks post treatment end (ie weeks 36 or 60)
Relapse rate
End of treatment (ie weeks 24 or 48)
Adverse events (AEs), laboratory parameters.
Throughout treatment

Study Arms (7)

Group 1

EXPERIMENTAL

Group 1 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1000 po bid) plus PEGASYS (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).