420
Participants
Start Date
May 7, 2014
Primary Completion Date
March 23, 2016
Study Completion Date
February 21, 2017
Narlaprevir
yellow film-coated 100 mg. tablets
Ritonavir
100 mg tablets encapsulates in gelatin capsules (for blinding purposes)
Placebo Narlaprevir
yellow film-coated 100 mg. tablets identical to Narlaprevir tablets
Placebo Ritonavir
100 mg lactose/ cellulose tablets encapsulated in gelatin capsules (for blinding purposes) identical to Ritonavir capsules
Pegylated interferon alfa-2a/ Pegylated interferon alfa-2b
180µg for subcutaneous injections in 0.5 ml syrettes / 1.5 µg/kg for subcutaneous injections in 50µkg, 80µkg,100µkg, 120µkg, 150µkg in vials
Ribavirin
"hard gelatin, white 200mg. capsules~Weight-based dose was 1000 mg/day (patient weight \<75 kg) or 1200 mg/day (patient weight ≥75 kg) with Peginterferon alfa-2a and 800 mg/day (patient weight \<65 kg) - 1400 (patient weight \>105 kg) mg/day with Peginterferon alfa-2b"
South-Ural State Medical University, Clinic of Medical Academy, Infectious Diseases Department, Chelyabinsk
Kazan State Medical Academy, Republican Clinical Hospital of Infectious Diseases n.a. A.F. Agafonov, Kazan'
Federal Budget Science Institution Central Science and Research Institute of Epidemiology of RosPotrebNadzor, Moscow
Federal State Budget Healthcare Institution Central Clinical Hospital of Russian Academy of Science, Moscow
First Moscow State Medical University n.a. I.M. Sechenov, Clinic of Nephrology, Internal and Professional Diseases n.a. E.M. Tarleev, Moscow
First Moscow State Medical University n.a. I.M. Sechenov, Propedeutics of Internal Diseases Department, Moscow
Moscow State Medical Stomatological University n.a. A. I. Evdokimov, Clinical Infectious Hospital #1, Clinical Infections Department, Moscow
"Public Corporation Clinical Hospital of Centrosouze", Moscow
"Public Corporation MedElitConsulting", Moscow
State Budget Healthcare Moscow Institution Clinical Scientific Center of Healthcare Department of Moscow, Moscow
State Budgetary Healthcare Organization Clinical city hospital #24, Moscow
Novosibirsk State Medical University, Clinical city hospital #12, Therapeutic Department, Novosibirsk
Military Medical Academy of Ministry of Defense of Russian Federation n.a. S.M. Kirov, Infectious Diseases Department, Saint Petersburg
Saint Petersburg State Budget Healthcare Institution Center of AIDS and Infectious Diseases Prevention and Control, Saint Petersburg
Saint Petersburg State Budgetary Healthcare Institution Clinical Hospital of Infectious Diseases n.a. S.P. Botkin, Saint Petersburg
Clinic of Samara State Medical University, Department of Infectious Diseases, Samara
"Public corporation Medical company Gepatolog", Samara
Municipal Healthcare Institution Clinical city hospital #2 n.a. V.I. Razumovsky, Infectious Diseases Department, Saratov
Stavropolsky Krai Clinical Hospital, Gastroenterology Department related to Hospital Therapy Department, Stavropol
Stavropolsky State Medical University, Clinic of Gastroenterology, Hepatology and Pancreatology, Stavropol
Lead Sponsor
R-Pharm
INDUSTRY