A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non-severe fibrosis.

Phase 1

• Conditions: viral hepatitis C; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-001363-37-FR
• Lead Sponsor: CHU de Clermont-Ferrand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-16
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

1 - Willing and able to provide written informed consent
2 - Male or female, age = 18 years
3 - Body Mass Index (BMI) = 18 kg/m2
4 - HCV RNA = 104 IU/mL at Screening
5- Chronic HCV infection (= 6 months) documented by prior medical history or liver biopsy. Only patients infected by genotype 1b virus will be included.
6 - Treatment-naïve with no prior exposure to any IFN, RBV, or approved or experimental HCV-specific DAA
7 – Non severe fibrosis (F < 2) according to Metavir score if a biopsy was performed or elasticity measured by Fibroscan® lower than 9.5 kPa or Fibrotest lower than 0.59 or Fibrometre lower than 0.63 if Fibroscan® cannot be performed.

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1 - Medical histaru with significant event
2- Significant abnormal lab results at screening
3 - Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson’s disease, alfa-1 antitrypsin deficiency, cholangitis)
4 - Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
5 - Clinically-relevant alcohol or drug abuse within 12 months of Screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the investigator

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified