A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Participants
- Conditions
- Hepatitis C Virus (HCV) genotype-1b InfectionTherapeutic area: Diseases [C] - Virus Diseases [C02]MedDRA version: 18.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations
- Registration Number
- EUCTR2014-003413-28-DE
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 110
- Participant must have chronic Hepatitis C virus (HCV) genotype 1b or 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
- Participant must have documented fibrosis stage at Screening (or between Screening and Day 1 [baseline]). Liver disease will be staged based on one of the following methods.
a) Shear wave elastography (Fibroscan) within less than or equal to (<=) 6 months before Screening or between Screening and Day 1 (baseline). METAVIR F3 > 9.6 Kilopascals (kPa) and the cut-off for cirrhosis is greater than or equal to (>=) 14.6 kPa.
b) A biopsy documenting METAVIR F0-F4. Biopsy performed within the 24 months before Screening will be accepted for participants with METAVIR score F0-F3. For cirrhotic participants (METAVIR score F4) a biopsy performed at any previous time is acceptable
- Participants who have cirrhosis must have an hepatic imaging procedure (ultrasound, computed tomography [CT] scan or magnetic resonance imaging [MRI]) within 6 months prior to the Screening visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma
- Participant must have a body mass index (BMI) >= 18 Kilogram per meter^2 (kg/m^2)
- Participant must be treatment naive (that is, have not received prior treatment for HCV with any approved or investigational drug)
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
- Participant has co-infection with HCV of another genotype.
a) Participant who has HCV genotype 1b has coinfection with HCV of a genotype other than genotype 1b.
b) Participant who has HCV genotype 4 has coinfection with HCV of a genotype other than genotype 4
- Chronic HCV genotype 1b-infected participant who has the presence of genetic variants coding for the NS5A-Y93H and/or L31M/V amino acid substitutions at Screening
- Participant has evidence of current or previous episodes of hepatic decompensation (including controlled or uncontrolled ascites, bleeding varices or hepatic encephalopathy)
- Participant has chronic liver disease of a non-HCV etiology (including but not limited to hemochromatosis, Wilson's disease, alfa 1-antitrypsin deficiency, cholangitis, drug- or alcohol-related liver disease, primary biliary cirrhosis)
- Participant has any other uncontrolled clinically significant disease or clinically significant findings during Screening 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 has coinfection with hepatitis A or hepatitis B virus (hepatitis A antibody immunoglobulin M [IgM] or hepatitis B surface antigen [HBsAg] positive at Screening)
- Participant has received a solid organ transplant
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: - To evaluate the efficacy of a 12- or 24-week treatment regimen containing simeprevir and daclatasvir with respect to the percentage of subjects achieving SVR4 and SVR24.<br>- To evaluate the incidence of on-treatment failure.<br>- To evaluate the incidence of viral relapse.<br>- To determine/characterize emerging NS3/4A and NS5A mutations in all subjects not achieving SVR.<br>- To evaluate safety and tolerability of a 12- or 24-week treatment regimen containing simeprevir and daclatasvir.;Main Objective: To determine the efficacy of a 12- or 24-week treatment regimen of simeprevir in combination with daclatasvir, as measured by SVR12, in treatmentnaïve, chronic HCV genotype 1b-infected subjects who have advanced fibrosis or compensated cirrhosis (METAVIR F3/F4).;Primary end point(s): Percentage of Participants With Sustained Virologic Response 12 Weeks After end of Study Drug Treatment (SVR12);Timepoint(s) of evaluation of this end point: 12 weeks after end of treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1- Percentage of Participants With Sustained Virologic Response 12 Weeks After end of Study Drug Treatment (SVR12)<br>2- Percentage of Participants with SVR 4 Weeks After end of Study Drug Treatment (SVR4) and SVR 24 Weeks After end of Study Drug Treatment (SVR24)<br>3- Percentage of Participants with On-treatment Failure<br>4- Percentage of Participants with viral breakthrough<br>5- Percentage of Participants With Viral Relapse;Timepoint(s) of evaluation of this end point: 1- Week 24 or Week 36<br>2- For SVR4: Week 16 or 28; for SVR24: Week 36 or 48<br>3- Week 12 or Week 24<br>4- Week 12 or Week 24<br>5- Week 12 or Week 24