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

NCT02114151 | Completed Phase 3 Results DMC

• 2 other identifiers: CR103431TMC435HPC3018
• Study Type: interventional
• Target: 103
• Locations: 2 countries
• Sites: 34

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.

Conditions

Hepatitis C Virus Infection

Keywords

Hepatitis C Virus Infection; Simeprevir; Sofosbuvir; HCV; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT)

  Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the actual end of treatment.

  Week 24

Secondary Outcomes (11)

• Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT)

  Week 16

• Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT)

  Week 36

• Percentage of Participants With On-treatment Virologic Response

  Week 2, 4 and End of Treatment (Week 12)

• Percentage of Participants With On-treatment Failure

  Week 12

• Percentage of Participants With Viral Breakthrough

  Up to End of Treatment (Week 12)

Study Arms (1)

Arm 1 (Simeprevir/Sofosbuvir)

EXPERIMENTAL

100 participants will receive 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.

Drug: Simeprevir; Drug: Sofosbuvir

Interventions

Simeprevir DRUG

100 participants will receive 1 capsule of 150 mg orally once daily for 12 weeks.

Arm 1 (Simeprevir/Sofosbuvir)

Sofosbuvir DRUG

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

Arm 1 (Simeprevir/Sofosbuvir)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Infectious Diseases BVBA: lead

Study Sites (34)

Unknown Facility

Dothan, Alabama, United States

Location

Unknown Facility

Bakersfield, California, United States

Location

Unknown Facility

Chula Vista, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Englewood, Colorado, United States

Location

Unknown Facility

Bradenton, Florida, United States

Location

Unknown Facility

Lauderdale Lakes, Florida, United States

Location

Unknown Facility

Maitland, Florida, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Wellington, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Columbus, Georgia, United States

Location

Unknown Facility

Marietta, Georgia, United States

Location

Unknown Facility

Jackson, Mississippi, United States

Location

Unknown Facility

Kansas City, Missouri, United States

Location

Unknown Facility

Hillsborough, New Jersey, United States

Location

Unknown Facility

Vineland, New Jersey, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Asheville, North Carolina, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

East Greenwich, Rhode Island, United States

Location

Unknown Facility

Providence, Rhode Island, United States

Location

Unknown Facility

Greer, South Carolina, United States

Location

Unknown Facility

Germantown, Tennessee, United States

Location

Unknown Facility

Knoxville, Tennessee, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Arlington, Texas, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Norfolk, Virginia, United States

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Hepatitis C; Fibrosis

Interventions

Simeprevir; Sofosbuvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Results Point of Contact

• Title: Associate Director
• Organization: Janssen Infectious Diseases - Diagnostics BVBA

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Janssen Infectious Diseases BVBA Clinical Trial

  Janssen Infectious Diseases BVBA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 15, 2014
• Study Start: April 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 4, 2016
• Results First Posted: April 4, 2016

Record last verified: 2016-03

Locations

US (32); CA (2)