A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Participants

NCT ID: NCT02268864

Last Updated: 2017-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-04-30

Brief Summary

The purpose of this study is to determine the efficacy of a 12- or 24-week treatment regimen of simeprevir in combination with daclatasvir, as measured by sustain virologic response 12 (SVR12), in treatment-naive, chronic hepatitis C virus (HCV) genotype 1b-infected participants who have advanced fibrosis or compensated cirrhosis (METAVIR F3/F4).

Detailed Description

This is an open-label (all people know which treatment the participants receive) study to investigate the efficacy, safety and tolerability of simeprevir and daclatasvir in chronic Hepatitis (inflammation of the liver) C virus (HCV) genotype 1b infected participants who are treatment-naive. The total study duration for each participant will be approximately 40 weeks or approximately 52 weeks. The study will consist of 4 parts: Screening Phase (approximately 4 weeks) and open-label treatment Phase (12 weeks), optional open label treatment phase extension (12 Weeks) and follow-up Phase (up to Week 40 or Week 52). Participants will receive simeprevir (150 milligram [mg] capsule) and daclatasvir (60 mg tablet) orally once daily for 12 or 24 weeks. Efficacy will be primarily evaluated by percentage of participants with SVR12. Participants' safety will be monitored throughout the study.

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Simeprevir + Daclatasvir

Participants who have Hepatitis C virus (HCV) genotype 1b infection with advanced fibrosis or compensated cirrhosis (METAVIR F3/F4) will receive simeprevir 150 milligram (mg) capsule and daclatasvir 60 mg tablet orally once daily for 12 or 24 weeks.

Group Type: EXPERIMENTAL

Simeprevir

Intervention Type: DRUG

Simeprevir 150 mg oral capsule will be administered once daily for 12 or 24 weeks.

Daclatasvir

Intervention Type: DRUG

Daclatasvir 60 mg oral tablet will be administered once daily for 12 or 24 weeks.

Interventions

Simeprevir

Simeprevir 150 mg oral capsule will be administered once daily for 12 or 24 weeks.

Intervention Type: DRUG

Daclatasvir

Daclatasvir 60 mg oral tablet will be administered once daily for 12 or 24 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participant must have chronic Hepatitis C virus (HCV) genotype 1b 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 F3-F4. Biopsy performed within the 24 months before Screening will be accepted for participants with METAVIR score 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)

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag International NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag International NV Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

Antwerp, , Belgium

Brussels, , Belgium

Ghent, , Belgium

Créteil, , France

Lyon, , France

Montpellier, , France

Nice, , France

Paris, , France

Vandœuvre-lès-Nancy, , France

Frankfurt, , Germany

Hamburg, , Germany

Hanover, , Germany

Kiel, , Germany

Tübingen, , Germany

Würzburg, , Germany

Budapest, , Hungary

Debrecen, , Hungary

Badalona, , Spain

Barcelona, , Spain

Santander, , Spain

Valencia, , Spain

Birmingham, , United Kingdom

London, , United Kingdom

Countries

Belgium; France; Germany; Hungary; Spain; United Kingdom

References

Hezode C, Almasio PL, Bourgeois S, Buggisch P, Brown A, Diago M, Horsmans Y, Serfaty L, Szalay F, Gaeta GB, Planas R, Schlag M, Lonjon-Domanec I, Omoruyi E, DeMasi R, Zeuzem S. Simeprevir and daclatasvir for 12 or 24 weeks in treatment-naive patients with hepatitis C virus genotype 1b and advanced liver disease. Liver Int. 2017 Sep;37(9):1304-1313. doi: 10.1111/liv.13376. Epub 2017 Mar 13.

Reference Type: DERIVED

PMID: 28135777 (View on PubMed)

Other Identifiers

2014-003413-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TMC435HPC2019

Identifier Type: OTHER

Identifier Source: secondary_id

CR105490

Identifier Type: -

Identifier Source: org_study_id