Clinical trial NCT02250807: Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection
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-Naive or -Experienced Subjects With Chronic Genotype 4 Hepatitis C Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Genotype 4 Chronic Hepatitis C
Keywords: Chronic hepatitis C
Genotype 4 chronic hepatitis C
Simeprevir
Sofosbuvir
Lead sponsor: Janssen R&D Ireland
Sponsor class: INDUSTRY
First posted: 2014-09-26
Enrollment: 40
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 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.

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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)
timeFrame: 12 weeks after EOT
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Therapy (SVR4)
timeFrame: 4 weeks after EOT
measure: Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Therapy (SVR24)
timeFrame: At 24 weeks after EOT
measure: Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
timeFrame: Week 2, 3, 4, 12 and EOT
measure: Percentage of Participants With On-Treatment Failure
timeFrame: through 12 weeks (EOT)
measure: Percentage of Participants With Viral Breakthrough
timeFrame: Up to follow-up Week 24
measure: Percentage of Participants With Viral Relapse
timeFrame: Up to follow-up week 24
Other outcomes:
Locations:
city: Badalona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Santander N/A
country: Spain
city: Sevilla N/A
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Janssen R&D Ireland
name: Janssen R&D Ireland Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.