A Study to Research what the body does with the study drug after treatment with Simeprevir, Sofosbuvir and Ledipasvir in patients with Chronic Hepatitis C Virus Genotype 1 Infection who have not yet started anti-viral treatment.

Phase 1

Conditions: Chronic Hepatitus C Virus (HCV) Genotype 1 Infection
MedDRA version: 18.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2015-000459-25-BE

Lead Sponsor: Janssen Sciences Ireland UC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

- Participants with chronic Hepatitis C Virus (HCV) genotype 1 infection between 18 to 70 years, inclusive, confirmed at screening
- Participants must be treatment-naïve (that is, have not received prior treatment with any approved or investigational drug)
- Participants with HCV ribonucleic acid (RNA) plasma levels greater than 10,000 international unit per milliliter (IU/ml) and lower than 6,000,000 international unit per milliliter (IU/ml) at screening
- Participants with absence of cirrhosis confirmed by FibroTest/Fibrosure score less or equal to 0.75 and an aspartate aminotransferase to platelet ration index less or equal to 2 or a Fibroscan less or equal to 14.6 kilopascale (kPA), performed within 6 months prior or during the screening period

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

- Participant has infection/co-infection with HCV of a genotype other than genotype 1, human immunodeficiency virus (HIV) type 1 or 2.
- Participant has any evidence of liver disease of non-HCV etiology. This includes, but is not limited to acute hepatitis A, active hepatitis B, 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-HC liver disease considered clinically significant by the investigator.
- Participant with significant co-morbidities, conditions or clinical significant findings during screening assessments that in the opinion of the investigator could compromise the participants’ safety or could interfere with the Participant participating in and completing the study
- Participant received an organ transplant (other than cornea or hair transplant or skin graft)
- Participants have key protocol defined laboratory abnormalities