NCT02483156View on ClinicalTrials.gov

Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Tablet Plus Ribavirin Tablet (Part A) Versus Single Dose (2 Tablets) of EHCV Containing Sofosbuvir, Ribavirin, and Natural Anti-hemolytic (B) in Egyptian Adults With Chronic Genotype 4 HCV Infection

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

August 31, 2015

Conditions
Hepatitis c
Interventions
DRUG

Two tablets of EHCV in Single Dose each tablet containing SOF 200 mg, RBV 500 mg and Natural anti-hemolytic (AH) at 200 mg

The fixed dose EHCV combinations in Single Dose (2 tablets) once daily each tablet containing SOF 200 mg, RBV 500 mg, and Natural anti-hemolytic (AH) at 200 mg. Subjects will take 2 tablet with food for 12-24 weeks.

DRUG

Sofosbuvir tablet (SOF) 400 mg - once daily

SOF is manufactured as a 400 mg tablet for oral administration. Subjects will take 1 tablet for a total dose of 400 mg orally once daily in the morning with RBV and with food for 12-24 weeks.

DRUG

Ribavirin (RBV) 1000 mg - splitted on 2 doses daily - 600 mg on morning and 400 mg on evening

RBV (1000 mg.) splitted on 2 doses daily - 600 mg on morning and 400 mg on evening with SOF and with food for 12-24 weeks.

Trial Locations (1)

35516

Egyptian Liver Hospital, Sherbin

All Listed Sponsors
collaborator

Wadi El Nil Hospital

UNKNOWN

lead

Egyptian Liver Hospital

OTHER

NCT02483156 - Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Tablet Plus Ribavirin Tablet (Part A) Versus Single Dose (2 Tablets) of EHCV Containing Sofosbuvir, Ribavirin, and Natural Anti-hemolytic (B) in Egyptian Adults With Chronic Genotype 4 HCV Infection | Biotech Hunter | Biotech Hunter