Chronic Hepatitis C Genotype 2 and 3 patients MedDRA version: 12.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C
Conditions
Interventions
Product Name: DEB025
Product Code: DEB025
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Alisporivir
CAS Number: 25443509505
Current Sponsor code: DEB025
Concentration unit: mg milligram(s)
C
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key inclusion criteria are: Written informed consent prior to any assessment; Males or females aged =18 and = 70 years; BMI between = 18 and = 36 kg/m2; Chronic hepatitis C virus infection; Plasma HCV RNA = 10000 IU/ml; no upper limit; Infection with HCV genotype 2 or 3; HCV treatment naïve; Female patients of child bearing potential must have a negative pregnancy test at screening and immediately prior to first administration of study 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Key exclusion criteria are: Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; Any contraindications to peg-IFNa2a and/or RBV treatment; Active or suspected cancer, or a history of malignancy where the risk of recurrence is = 20% within 2 years; HBsAg positive or HIV positive; Elevated (= ULN) total bilirubin level at screening. Gilbert´s disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the proportion of patients who achieve RVR with DEB025 600mg QD plus RBV 400 mg BID, DEB025 800 mg QD plus RBV 400 mg BID and DEB025 1000 mg QD treatment groups, in treatment-naïve chronic hepatitis C genotype 2/3 patients.;Secondary Objective: The key secondary objective is to evaluate the proportion of patients with RVR on interferon free treatment who also achieve SVR 24 in treatment-naïve chronic hepatitis C genotype 2/3 patients.;Primary end point(s): Proportion of patients who achieve RVR with DEB025 600mg QD plus RBV 400 mg BID, DEB025 800 mg QD plus RBV 400 mg BID and DEB025 1000 mg QD treatment groups, in treatment-naïve chronic hepatitis C genotype 2/3 patients | — |
Countries
Belgium, Germany, Italy, Poland, United Kingdom
Outcome results
None listed