Clinical trial NCT02114151: Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus Infection
Keywords: Hepatitis C Virus Infection
Simeprevir
Sofosbuvir
HCV
Cirrhosis
Lead sponsor: Janssen Infectious Diseases BVBA
Sponsor class: INDUSTRY
First posted: 2014-04-15
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This is a open-label (all people know the identity of the intervention), single arm, multicenter study. The study will consist of a screening phase up to 4 weeks, open-label treatment phase of 12 weeks, and post-treatment follow up phase up to 24 weeks after end of treatment. Approximately 100 participants will receive 150 mg simeprevir in combination with 400 mg sofosbuvir once dailyfor 12 weeks. Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and physical examination. The maximum study duration for each participant will be approximately 40 weeks.

Eligibility criteria: Inclusion Criteria:

* Hepatitis C virus (HCV) genotype 1 infection (confirmed at screening).
* HCV ribonucleic acid (RNA) greater than 10,000 IU/mL at screening
* Treatment-experienced participants must have at least 1 documented previous course of interferon-based regimen with or without ribavirin
* Participants must have an hepatic imaging procedure (ultrasound, computerized tomography scan or magnetic resonance imaging scan) within 6 months prior to the screening visit (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma
* Participant must be willing and able to comply with the protocol requirements
* Participants with liver cirrhosis

Exclusion Criteria:

* Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy)
* Infection/co-infection with HCV non-genotype 1
* Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening)
* Co-infection with hepatitis B virus (hepatitis B-surface-antigen positive)
* Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection

Primary outcomes:
measure: Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT)
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT)
timeFrame: Week 16
measure: Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT)
timeFrame: Week 36
measure: Percentage of Participants With On-treatment Virologic Response
timeFrame: Week 2, 4 and End of Treatment (Week 12)
measure: Percentage of Participants With On-treatment Failure
timeFrame: Week 12
measure: Percentage of Participants With Viral Breakthrough
timeFrame: Up to End of Treatment (Week 12)
measure: Percentage of Participants With Viral Relapse
timeFrame: During the Follow-up (Week 24)
measure: Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Overall Body System Score (OBSS) up to Follow-up Week 12
timeFrame: Baseline, Week 4, Week 12 and Follow-Up Week 12
measure: Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24
timeFrame: Baseline, Week 12, Follow-up Week 12 and 24
measure: Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Baseline, Week 12, Follow-up Week 12 and 24
measure: Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24
timeFrame: Baseline, Follow-up Week 12 and 24
measure: Number of Participants Not Achieving SVR Showing Emerging Mutation at Time of Failure in HCV NS3/4A Sequence and NS5B up to Follow-up Week 24
timeFrame: Baseline, Day 3, Week 1, 2, 3, 4, 8, 12, Follow-up Week 4, 12 and 24
Other outcomes:
Locations:
city: Dothan
country: United States
state: Alabama
city: Bakersfield
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Englewood
country: United States
state: Colorado
city: Bradenton
country: United States
state: Florida
city: Lauderdale Lakes
country: United States
state: Florida
city: Maitland
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Jackson
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: Hillsborough
country: United States
state: New Jersey
city: Vineland
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: East Greenwich
country: United States
state: Rhode Island
city: Providence
country: United States
state: Rhode Island
city: Greer
country: United States
state: South Carolina
city: Germantown
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Vancouver
country: Canada
state: British Columbia
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Janssen Infectious Diseases BVBA
name: Janssen Infectious Diseases BVBA Clinical Trial
role: STUDY_DIRECTOR
References: