To determine safety, tolerability, and preliminary efficacy of escalating doses of SD-101 alone and SD-101 plus ribavirin in subjects with chronic hepatitis C and no prior therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
34
Klinika Chorób Zakaźnych i Hepatologii Collegium Medicum Uniwersytet Mikołaja Kopernika
Bydgoszcz, Poland
Katedra i Klinika Chorób Zakaźnych Uniwersytet Medyczny w Lublinie
Lublin, Poland
Wojewódzki Szpital Zakaźny - Klinika Hepatologii i Nabytych Niedoborów Immunologicznych
Warsaw, Poland
Wojewódzki Szpital Zakaźny
Warsaw, Poland
Adverse event timing, duration, and severity.
Time frame: Between doses and up to 3 months after last dose
Biomarker analysis of blood sample
Time frame: pre and 24 hour post dose
Viral load in blood sample
Time frame: each visit
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EMC Instytut Medyczny S.A. Szpital Specjalistyczny z Przychodnią "EuroMediCare"
Wroclaw, Poland