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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02250807
• Other study ID #: CR105429
• Secondary ID: TMC435HPC3021201
• Status: Completed
• Phase: Phase 3
• First received: September 24, 2014
• Last updated: January 20, 2016
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Janssen R&D Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT02256176

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Genotype 4 Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Virus Diseases

Intervention

Drug:
• Simeprevir
Subjects will receive oral capsule of Simeprevir 150 mg, once a day from Day 1 up to Week 12.
• Sofosbuvir
Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen R&D Ireland

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Sustained Virologic Response (SVR 12) at Week 12 After End of Treatment (EOT)	Subject will be considered to have reached SVR 12, if hepatitis C virus (HCV) is less than (<) 15 international units per milliliter (IU/mL) at Week 12 after EOT.	Week 12 after EOT	No
Secondary	Percentage of Subjects With Sustained Virologic Response at Week 4 (SVR 4) and 24 (SVR 24) After EOT	Subject will be considered to have reached SVR 4, if hepatitis C virus (HCV) is <15 IU/mL at Week 4 after EOT and SVR 24, if hepatitis C virus (HCV) is <15 IU/mL at Week 24 after EOT.	Week 4 and 24 after EOT	No
Secondary	Percentage of Subjects With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)	Subject will be considered to have on treatment virologic response if HCV RNA value is <15 IU/mL.	Baseline, Week 1, 2, 3, 4 and 8	No
Secondary	Percentage of Subjects With on-treatment failure along with Viral Breakthrough	Subject will be considered to have on-treatment failure if they have detectable HCV RNA (<15 IU/mL detectable or >=15 IU/mL) at EOT. Viral breakthrough is defined as greater than (>) 1.0 log base 10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in subjects who had previously achieved HCV RNA <15 IU/mL.	Baseline up to EOT (Week 12)	No
Secondary	Percentage of Subjects With Viral Relapse	Subject will be considered to have viral relapse if they do not achieve SVR 4, 12 or 24 and meet the following conditions: 1) At EOT, HCV RNA <15 IU/mL, undetectable and 2) During the follow-up period, HCV RNA >=15 IU/mL.	Week 4, 12 and 24 after EOT	No