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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

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

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

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 safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC <br>• 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.<br>• To explore the pharmacokinetics and pharmacodynamics of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1<br>• 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.

Secondary Outcome Measures

Name	Time	Method

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