Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection

NCT02250807 | Completed Phase 3 Results

• 3 other identifiers: CR105429TMC435HPC30212014-003446-27
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to show superiority of simeprevir (SMV) in combination with sofosbuvir for 12 weeks versus a historical control. Historical control will be a composite of the observed historical sustained virological response at Week 12 (SVR12) rates of SMV in combination with (pegylated) interferon (PegIFN)/ribavirin (RBV) of the subpopulations in study HPC3011 (NCT01567735) and will depend on the percentage of treatment-naive, prior relapser, prior non-responder, interferon (IFN)-intolerant and other subjects enrolled in this study.

Conditions

Chronic Hepatitis C; Genotype 4 Chronic Hepatitis C

Keywords

Chronic hepatitis C; Genotype 4 chronic hepatitis C; Simeprevir; Sofosbuvir

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)

  SVR12 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \[IU/mL\]) detectable or undetectable 12 weeks after actual EOT.

  12 weeks after EOT

Secondary Outcomes (6)

• Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Therapy (SVR4)

  4 weeks after EOT

• Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Therapy (SVR24)

  At 24 weeks after EOT

• Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)

  Week 2, 3, 4, 12 and EOT

• Percentage of Participants With On-Treatment Failure

  through 12 weeks (EOT)

• Percentage of Participants With Viral Breakthrough

  Up to follow-up Week 24

Study Arms (1)

Simeprevir and Sofosbuvir

EXPERIMENTAL

Subjects will receive oral capsule of Simeprevir 150 milligram (mg) along with oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12.

Drug: Simeprevir; Drug: Sofosbuvir

Interventions

Simeprevir DRUG

Subjects will receive oral capsule of Simeprevir 150 mg, once a day from Day 1 up to Week 12.

Also known as: TMC435

Simeprevir and Sofosbuvir

Sofosbuvir DRUG

Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12.

Simeprevir and 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:

• Subjects with confirmed hepatitis C virus (HCV) with HCV RNA greater than (\>) 10000 international unit per milliliter (IU/mL)
• Subjects who are treatment naive or treatment-experienced.
• Subjects must have documentation of a liver biopsy or fibroscan or agree to have one during screening
• Subjects with cirrhosis must have an hepatic imaging procedure (ultrasound, CT scan or magnetic resonance imaging \[MRI\]) within 6 months before the screening visit (or during the screening period) with no findings suspicious for hepatocellular carcinoma (HCC)
• Women of childbearing potential or men with a female partner of childbearing potential must agree to use an effective form of contraception, or not be heterosexually active, or of nonchildbearing potential

You may not qualify if:

• Evidence of clinical hepatic decompensation
• Any liver disease of non-HCV etiology
• Subjects with a past history of treatment with an approved or investigational DAA
• 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)
• Infection/co-infection with HCV non-genotype 4

Sponsors & Collaborators

• Janssen R&D Ireland: lead

Study Sites (6)

Unknown Facility

Badalona, Spain

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Santander, Spain

Location

Unknown Facility

Seville, Spain

Location

Unknown Facility

Valencia, Spain

Location

Related Publications (1)

• Buti M, Calleja JL, Lens S, Diago M, Ortega E, Crespo J, Planas R, Romero-Gomez M, Rodriguez FG, Pascasio JM, Fevery B, Kurland D, Corbett C, Kalmeijer R, Jessner W. Simeprevir in combination with sofosbuvir in treatment-naive and -experienced patients with hepatitis C virus genotype 4 infection: a Phase III, open-label, single-arm study (PLUTO). Aliment Pharmacol Ther. 2017 Feb;45(3):468-475. doi: 10.1111/apt.13883. Epub 2016 Nov 29.

  PMID: 27896822 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Simeprevir; Sofosbuvir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; 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: Trial Physician
• Organization: Janssen R&D BE

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Janssen R&D Ireland Clinical Trials

  Janssen R&D Ireland

  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: September 24, 2014
• First Posted: September 26, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 17, 2016
• Results First Posted: November 17, 2016

Record last verified: 2016-09

Locations

ES (6)