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Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis

NCT02114177 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2016-04-12

Study results available
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Summary

The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12 weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or treatment-experienced.

Conditions

  • Hepatitis C Virus Infection

Interventions

DRUG

Simeprevir

150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 12 weeks in Arm 1.

DRUG

Simeprevir

150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 8 weeks in Arm 2

DRUG

Sofosbuvir

150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks in Arm 1.

DRUG

Sofosbuvir

150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 8 weeks in Arm 2.

Sponsors & Collaborators

  • Janssen Infectious Diseases BVBA

    lead INDUSTRY

Principal Investigators

  • Janssen Infectious Diseases BVBA Clinical Trial · Janssen Infectious Diseases BVBA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-01-31
Completion
2015-04-30

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02114177 on ClinicalTrials.gov