Status:

COMPLETED

A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Hepatitis C, Chronic

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boce...

Eligibility Criteria

Inclusion

  • Adult patients, \>/=18 years of age
  • Chronic hepatitis C infection for at least 6 months duration
  • Hepatitis C genotype 1a or 1b
  • Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
  • Patient showed a previous null response to therapy as defined by \< 2 log10 IU/mL decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV

Exclusion

  • Hepatitis C infection with a genotype other than genotype 1a or 1b
  • Body mass index \<18 or \>/=36
  • Hepatitis A, hepatitis B, or HIV infection
  • Herbal remedies \</=1 month prior to the first dose of study drug

Key Trial Info

Start Date :

November 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2014

Estimated Enrollment :

58 Patients enrolled

Trial Details

Trial ID

NCT01482403

Start Date

November 1 2011

End Date

January 1 2014

Last Update

August 5 2016

Active Locations (24)

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Page 1 of 6 (24 locations)

1

Littleton, Colorado, United States, 80120

2

Chicago, Illinois, United States, 60637

3

Shreveport, Louisiana, United States, 71130

4

Detroit, Michigan, United States, 48202