Hepatitis C genotype 1 relapser MedDRA version: 9.1 Level: LLT Classification code 10019744 Term: Hepatitis C
Conditions
Interventions
Product Code: NIM811
Pharmaceutical Form: Oral solution
Current Sponsor code: NIM811
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutic
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o Chronic Hepatitis C infection Genotype 1 with documented histology and biochemical results consistent with compensated chronic hepatitis C. o HCV-RNA should be = 4 x 100000 IU/mL at screening. o Male and female subjects from 18 to and including 69 years of age, with Chronic Hepatitis C genotype 1 o Recipient of prior long acting interferon (either as PegIntron, Pegasys or albumin-interferon alpha-2b) and ribavirin (either ribavirin or the ribavirin pro-drug, viramidine) treatment for at least 12 weeks, with documented negative serum HCV RNA on treatment , who subsequently becomes serum HCV RNA positive after stopping treatment (“relapser”). Patients must have been off all treatment for at least 3 months prior to start study(visit 1). Appropriate documentation of viral load will be provided in the patient’s source documentation for verification of relapse status o Platelets counts > 150,000/mm3 o No evidence of cirrhosis by any approved method: transient elastography, liver biopsy or Fibrotest, or any future approved validated method 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: o Contraindication to either pegylated interferon or ribavirin o Pregnant or breast-feeding females o Women of child bearing potential not willing to use 2 methods of contraception o Hepatic decompensation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC • To identify a dose of NIM811 which is safe and tolerated and produces in combination with SOC a clinically meaningful improvement over SOC dual therapy in antiviral response.;Secondary Objective: • To assess the percentage of patients achieving rapid virologic response (RVR) in patients treated with NIM811 in combination with SOC. • To explore the pharmacokinetics and pharmacodynamics of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1 • To evaluate the effect of NIM811 given in combination with SOC in patients with chronic hepatitis C on sustained virologic response at 24 weeks after the cessation of treatment (SVR24);Primary end point(s): Study part 1 is intended mainly for safety. The main end points will be adverse events and changes in laboratory values, in particular the change from baseline in platelet count observed at week 4. | — |
Countries
Belgium, Germany, Italy, Netherlands, Spain
Outcome results
None listed