Chronic Hepatitis C Genotype-1 Relapse
Conditions
Keywords
NIM811, chronic hepatitis, chronic hepatitis C, chronic hepatitis C genotype-1, HCV, HCV-1, relapser
Brief summary
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.
Interventions
DRUGNIM811
BID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV)
DRUGPlacebo BID + SOC
Placebo BID + SOC (PEG IFN and RBV)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC | 4 weeks |
Secondary
| Measure | 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 |
Countries
Australia, Belgium, Germany, Puerto Rico, Spain, Taiwan, United States
Outcome results
None listed