A randomized, adaptive-design dose finding study to assess the antiviral efficacy and safety of NIM811 administered in combination with Standard of Care (SOC) for 12 weeks in relapsed HCV-1 infected patients - ND

• Conditions: relapsed HCV-1 infected patients; MedDRA version: 9.1Level: LLTClassification code 10019744Term: Hepatitis C

• Registration Number: EUCTR2009-009995-11-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

o Chronic Hepatitis C infection Genotype 1 o HCV-RNA should be ≥ 4 x 105 IU/mL at screening. o Male and female subjects age 18 to 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 12 weeks. Appropriate documentation of viral load will be provided in the patient?s source documentation for verification of relapse status o Platelets counts > 125,000 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

o Contraindication to either pegylated interferon or ribavirin o Pregnant or lactating females o Hepatic decompensation

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy, safety and tolerability of several doses of NIM811 and SOC versus placebo and SOC in patients with chronic hepatitis C (CHC) genotype 1 given in combination for 12 weeks;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): To evaluate the efficacy, safety and tolerability of several doses of NIM811 and SOC versus placebo and SOC in patients with chronic hepatitis C (CHC) genotype 1 given in combination for 12 weeks