Adaptive-design Dose Finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With Standard of Care (SOC) in Relapsed Hepatitis C Virus 1 (HCV-1) Infected Patients

Study Overview
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Brief Summary
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This is a study designed to identify a dose of NIM811 that has a good safety profile, is well tolerated when co-administered with SOC, and provides a clinically meaningful effect in viral load reduction compared to SOC alone. This information will be used to support doses selected for future studies.

Official Title
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A Randomized, Adaptive-design, Dose-finding Study to Assess the Antiviral Efficacy and Safety of NIM811 Administered in Combination With the Standard of Care (SOC) in Relapsed Patients Infected With HCV Genotype-1

Conditions
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Chronic Hepatitis C Genotype-1 Relapse

Intervention / Treatment
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* Drug: NIM811
* Drug: Placebo BID + SOC


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients eligible for inclusion in this study have to fulfill all of the following criteria: chronic hepatitis C genotype-1 HCV-RNA should be ≥ 4 x 105 IU/mL at screening Recipient of prior long acting interferon and ribavirin 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 of study (Visit Exclusion criteria: Use of any HCV treatment ≤ 3months prior to study start Prior receipt of any investigational anti-HCV therapy which is not IFN or RBV Women of child-bearing potential unless they are post-menopausal or use predefined acceptable methods of contraception Pregnant or breastfeeding women Evidence of cirrhosis, hepatic decompensation, other than HCV liver disease, HBV or HIV infection Specified abnormalities in lab values of amongst others hemoglobin, WBC, ANC, platelets History of treatment for depression Steroid/immunosuppression drug use 3 months prior to study start Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIM811<br> | Drug: NIM811<br>* BID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo BID + SOC<br>* Placebo BID + SOC (PEG IFN and RBV)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify a dose of NIM811 which is safe and tolerated and produces in combination with SOC a clinically meaningful improvement over SOC monotherapy in antiviral response Time Frame: 4 weeks |  | 12 weeks | 
| To assess the percentage of patients achieving rapid virologic response (RVR) in patients treated with NIM811 in combination with SOC |  | 4 weeks | 
| To explore the pharmacokinetics and pharmacodynamics of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1 |  | 3 weeks, 5 weeks | 
| To evaluate the effect of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1 on sustained virologic response 12 weeks after cessation of treatment (SVR12) |  | 12 weeks after cessation of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NIM811, chronic hepatitis, chronic hepatitis C, chronic hepatitis C genotype-1, HCV, HCV-1, relapser