Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Sofosbuvir in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1

PHASE2CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

May 6, 2019

Primary Completion Date

April 8, 2020

Study Completion Date

August 12, 2020

Conditions
Chronic Hepatitis c Genotype 1
Interventions
DRUG

Narlaprevir

100 mg oval shaped, concave, yellow film-coated tablets taken as 200 mg per os once daily. 28 tabs/36 tabs/ 56 tabs in bottle.

DRUG

Ritonavir

100 mg tablets taken as 100 mg per os once daily. 30 tablets in bottle

DRUG

Sofosbuvir

"400 mg yellow, capsule-shaped film-coated tablets debossed with GSI on one side and 7977 on the other side, taken as 400 mg per os once daily. 28 tablets in bottle."

Trial Locations (5)

111123

FBIS CSRI of Epidemiology of Federal Service on Customers, Moscow

115446

FSIS FRC of food and biotechnology, Moscow

125367

SBEI HPE MSMDU n.a. A.I. Evdokimov of Ministry of Health of Russia, Moscow

193163

FSBI HEI HPE Military Medical Academy n.a. S.M. Kirov, Saint Petersburg

Unknown

SPb SBIH Center on preventiomn and treatment of AIDS and infectional deseases, Saint Petersburg

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Almedis

INDUSTRY

collaborator

Scientific Center EFiS

UNKNOWN

collaborator

ChromSystemsLab

UNKNOWN

lead

R-Pharm

INDUSTRY