The main purpose of this study is to determine the safety and tolerability of multiple dosing of miravirsen in subjects infected with chronic hepatitis C. Secondary purpose includes assessment of pharmacokinetics of miravirsen and assessment of miravirsen's effect on HCV viral titer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
SC injection
SC injection
Alamo Medical Research
San Antonio, Texas, United States
J.W. Goethe University Hospital
Frankfurt, Germany
Academic Medical Center (AMC)
Amsterdam, Netherlands
Erasmus MC University Hospital
Rotterdam, Netherlands
Safety and tolerability
Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, 12 lead and ECG monitoring.
Time frame: regularly over 18 weeks
Pharmacokinetics
Appropriate PK parameters, e.g. maximum observed plasma drug concentrations, area under the plasma concentration-time curves, the apparent terminal rate constant and corresponding half-life for miravirsen.
Time frame: continuously over 4 weeks
Miravirsen treatment effect on viral titer
Time frame: regularly over 18 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Klinika Hepatologii i Nabytych Niedoborow Immunologicznych WUM
Warsaw, Poland
Fundacion de Investigation de Diego
San Juan, Puerto Rico
FNsP Bratislava, Nemocnica akad.
Bratislava, Slovakia