An Efficacy and Safety Study of a 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Participants With Chronic Genotype 4 Hepatitis C Virus Infection

• Register: ClinicalTrials.gov
• Last refreshed on: 24 October 2016
• Main ID: NCT02278419
• Date of registration: 28/10/2014
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• Public title: An Efficacy and Safety Study of a 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Participants With Chronic Genotype 4 Hepatitis C Virus Infection
• Scientific title: A Phase 2a, Partly Randomized, Open-label Trial to Investigate the Efficacy and Safety of an 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Subjects With Chronic Genotype 4 Hepatitis C Infection
• Date of first enrolment: December 2014
• Target sample size: 63
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02278419
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Egypt

Contacts

• Name: Janssen-Cilag International NV Clinical Trial
• Affiliation: Janssen-Cilag International NV

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participant must have hepatitis C virus (HCV) genotype 4 infection (confirmed at
screening)

- Participant must have HCV ribonucleic acid (RNA) greater than (>) 10,000
international unit per milliliter (IU/mL) at screening

- In participants with cirrhosis, a documented hepatic imaging procedure (ultrasound,
computed tomography [CT] scan, or magnetic resonance imaging [MRI]) within 6 months
before baseline (Day 1) to exclude hepatocellular carcinoma is required

- A woman of childbearing potential must have a negative serum (beta human chorionic
gonadotropin at screening and a negative urine pregnancy test on Day 1 before first
dose of study drug

- Females of childbearing potential or males with a female partner of childbearing
potential must agree to use 2 highly effective contraceptive methods (one of which is
a barrier method; eg, condom or diaphragm) from Day 1 (baseline) and continue until
30 days after the end of treatment (EOT) (or longer if dictated by local
regulations), or not be heterosexually active, or be a vasectomized male subject or a
female subject with a vasectomized partner, or be a female (subject or partner of
male subject) of non-childbearing potential (ie, postmenopausal for at least 2 years
or surgically sterile)

Exclusion Criteria:

- Participant has evidence of clinical hepatic decompensation (history or current
evidence of ascites, bleeding varices, or hepatic encephalopathy)

- Participant has any liver disease of non-HCV etiology. This includes, but is not
limited to, acute hepatitis A, drug- or alcohol-related liver disease, autoimmune
hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency,
non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver
disease considered clinically significant by the investigator

- Participant is infected/co-infected with non-genotype 4 HCV

- Participant has any other active clinically significant disease or clinically
significant findings during screening of medical history, physical examination,
laboratory testing or electrocardiogram (ECG) recordings that, in the investigator's
opinion, would compromise the participant's safety or could interfere with the
participant participating in and completing the study

- Participant has history of malignancy within 5 years of the screening visit
(exceptions: skin carcinomas, carcinoma in situ of the cervix, or malignancy that in
the opinion of the investigator is considered cured with minimal risk of recurrence)



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis C

Intervention(s)

Drug: Sofosbuvir

Drug: Simeprevir

Primary Outcome(s)

Percentage of Participants With Sustained Virologic Response at Week 12 After End of Treatment (SVR12) [Time Frame: 12 weeks after end of treatment (EOT) (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)]

Secondary Outcome(s)

Percentage of Participants With Viral Relapse [Time Frame: EOT (Week 8 for Group A1, Week 12 for Group A2 and Group B), Weeks 4, 12 and 24 after end of treatment]

Percentage of Participants With on-treatment Failure [Time Frame: EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)]

Percentage of Participants With Viral Breakthrough [Time Frame: Week 1 up to Week 8 in Group A1, Week 1 up to Week 12 in Group A2 and Group B]

Percentage of Participants With Sustained Virologic Response at Week 24 After End of Treatment (SVR24) [Time Frame: 24 weeks after EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)]

Percentage of Participants With On-treatment Response [Time Frame: Week 1, 2, 4, 8 and EOT for all groups, Week 12 for Group A2 and Group B]

Percentage of Participants With Sustained Virologic Response at Week 4 After End of Treatment (SVR4) [Time Frame: 4 weeks after EOT (EOT; Week 8 for Group A1, Week 12 for Group A2 and Group B)]

Secondary ID(s)

TMC435HPC2014

CR104970

Source(s) of Monetary Support

Please refer to primary and secondary sponsors