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

NCT ID: NCT02250807

Last Updated: 2016-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-12-31

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.

Detailed Description

This is a Phase 3, open-label (all people know the identity of the intervention), single-arm, multicenter study (conducted at multiple sites). The study consists of 3 periods: a Screening period (up to 4 weeks), Treatment period (12 Weeks) and Post treatment follow-up period (until 24 weeks after end of treatment). The duration of the subjects' participation will be approximately 40 weeks. In the treatment period subjects will receive oral capsule simeprevir along with oral tablet sofosbuvir once daily for 12 weeks. Primarily efficacy will be evaluated as percentage of subjects with sustained virologic response at Week 12 after the end of treatment. Subjects' safety will be monitored throughout the study.

Conditions

Chronic Hepatitis C; Genotype 4 Chronic Hepatitis C

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simeprevir and Sofosbuvir

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.

Group Type: EXPERIMENTAL

Simeprevir

Intervention Type: DRUG

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

Sofosbuvir

Intervention Type: DRUG

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

Interventions

Simeprevir

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

Intervention Type: DRUG

Sofosbuvir

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

Intervention Type: DRUG

Other Intervention Names

TMC435

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen R&D Ireland

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen R&D Ireland Clinical Trials

Role: STUDY_DIRECTOR

Janssen R&D Ireland

Locations

Badalona, , Spain

Barcelona, , Spain

Madrid, , Spain

Santander, , Spain

Seville, , Spain

Valencia, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 27896822 (View on PubMed)

Other Identifiers

TMC435HPC3021

Identifier Type: OTHER

Identifier Source: secondary_id

2014-003446-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR105429

Identifier Type: -

Identifier Source: org_study_id

NCT02256176

Identifier Type: -

Identifier Source: nct_alias