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Completed Phase 3 Interventional Results available

Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis

ClinicalTrials.gov ID: NCT02114151

Public ClinicalTrials.gov record NCT02114151. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 3:14 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection and Cirrhosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV) genotype 1 infected men and women with cirrhosis who are HCV treatment-naïve or treatment-experienced.

Study identification

NCT ID
NCT02114151
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
103 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 2014 (Type not available)
Primary completion
Jan 2015 (Actual)
Completion
Apr 2015 (Actual)
Last update posted
Apr 4, 2016

2014 – 2015

United States locations

U.S. sites
32
U.S. states
15
U.S. cities
32
Facility City State ZIP Site status
Not listed Dothan Alabama — —
Not listed Bakersfield California — —
Not listed Chula Vista California — —
Not listed Los Angeles California — —
Not listed San Diego California — —
Not listed Englewood Colorado — —
Not listed Bradenton Florida — —
Not listed Lauderdale Lakes Florida — —
Not listed Maitland Florida — —
Not listed Miami Florida — —
Not listed Orlando Florida — —
Not listed Wellington Florida — —
Not listed Atlanta Georgia — —
Not listed Columbus Georgia — —
Not listed Marietta Georgia — —
Not listed Jackson Mississippi — —
Not listed Kansas City Missouri — —
Not listed Hillsborough New Jersey — —
Not listed Vineland New Jersey — —
Not listed New York New York — —
Not listed Asheville North Carolina — —
Not listed Winston-Salem North Carolina — —
Not listed East Greenwich Rhode Island — —
Not listed Providence Rhode Island — —
Not listed Greer South Carolina — —
Not listed Germantown Tennessee — —
Not listed Knoxville Tennessee — —
Not listed Nashville Tennessee — —
Not listed Arlington Texas — —
Not listed Austin Texas — —
Not listed San Antonio Texas — —
Not listed Norfolk Virginia — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02114151, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 4, 2016 · Synced Oct 19, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02114151 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →