Status:

COMPLETED

Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection

Lead Sponsor:

Gilead Sciences

Conditions:

Chronic Hepatitis C

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Eligibility Criteria

Inclusion

  • Key
  • Willing and able to provide written informed consent
  • Chronic HCV infection
  • Cirrhosis determination (liver biopsy may be required)
  • Screening laboratory values within specified limits
  • Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
  • Specific genotype, prior medical history, or concurrent disease as required by the specific study group
  • Key

Exclusion

  • History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
  • Pregnant or nursing female, or male with pregnant female partner
  • Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
  • Use of any prohibited concomitant medications
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Key Trial Info

Start Date :

August 4 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 9 2016

Estimated Enrollment :

273 Patients enrolled

Trial Details

Trial ID

NCT02202980

Start Date

August 4 2014

End Date

May 9 2016

Last Update

November 16 2018

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Auckland, New Zealand

2

Christchurch, New Zealand