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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
59
BID in various doses (between 100 mg - 600 mg bid) + SOC (PEG IFN and RBV)
Placebo BID + SOC (PEG IFN and RBV)
Research and Education Inc.
San Diego, California, United States
Orlando Clinical Research Center
Orlando, Florida, United States
University Hepatitis Center
To evaluate the safety and tolerability of NIM811 dosed daily for 4 weeks in combination with SOC
Time frame: 4 weeks
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
Time frame: 12 weeks
To assess the percentage of patients achieving rapid virologic response (RVR) in patients treated with NIM811 in combination with SOC
Time frame: 4 weeks
To explore the pharmacokinetics and pharmacodynamics of NIM811 given in combination with SOC in patients with chronic hepatitis C genotype-1
Time frame: 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)
Time frame: 12 weeks after cessation of treatment
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Sarasota, Florida, United States
West Wind'r Research & Development LLC
Tampa, Florida, United States
Alamo Medical Research
San Antonio, Texas, United States
Novartis Investigative Site
Clayton, New South Wales, Australia
Novartis Investigative Site
Westmead, New South Wales, Australia
Novartis Investigative Site
Wentworthville, South Australia, Australia
Novartis Investigative Site
Brussels, Belgium
Novartis Investigative Site
Leuven, Belgium
...and 6 more locations