Chronic Hepatitis C Genotype 1 patients MedDRA version: 15.0 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Alisporivir
Product Code: DEB025
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Alisporivir
CAS Number: 254435095
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Chronic hepatitis C G1 viral infection Plasma HCV RNA level lower limit = 1,000 IU/ml assessed by qPCR (quantitative polymerase chain reaction) or equivalent at screening; no upper limit; HCV genotype 1; Previous non-responders/ relapsers to SOC after treatment for at least 12 weeks. other inclusion criteria may apply 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 442 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 19
Exclusion criteria
Exclusion criteria: Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, UNLESS they are using a highly effective contraception. other exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): cEVR (complete early virologic response) i.e. HCV RNA < 25 IU/mL (by Limit of Quantitation, LOQ);Timepoint(s) of evaluation of this end point: 12 weeks ;Main Objective: To demonstrate that in chronic hepatitis C Genotype 1 patients with previous non-response to peg-IFNa2a/RBV or with previous relapse after peg-IFNa2a/RBV treatment triple therapy with DEB025 leads to a superior cEVR (by Limit of Quantification, LOQ, i.e. HCV RNA < 25 IU/mL) rate as compared to peg-IFN/RBV ;Secondary Objective: To demonstrate that triple therapy with DEB025 plus peg-IFNa2a/RBV variable treatment duration followed by peg-IFN/RBV to complete a total treatment duration of 48 weeks leads to a superior SVR12 (HCV RNA < LOQ at the end of 12 week post-treatment follow-up) rate as compared to peg-IFN/RBV for 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): SVR12: sustained virologic response 12 weeks following cessation of therapy, defined as HCV RNA negative (by LOQ);Timepoint(s) of evaluation of this end point: 12 weeks post treatment | — |
Countries
Australia, Belgium, France, Germany, Hungary, Italy, Poland, Romania, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactMedical Information Services
Novartis Pharmaceuticals UK Limited
Outcome results
None listed