Treatment of Chronic Hepatitis C Infection by Ledipasvir/Sofosbuvir in Naïve Children

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

March 1, 2018

Primary Completion Date

August 30, 2019

Study Completion Date

March 10, 2020

Conditions
Hepatitis C, Chronic
Interventions
DRUG

Ledipasvir-Sofosbuvir 90 Mg-400 Mg Oral Tablet

proper history was taken. HCV genotyping was done revealed GT 4 in all included patients. Basic ECG and abdominal US were performed prior to treatment. Concomitant HBV infection was excluded by HBs Ag and anti-HBc antibody HIV screening was done prior to treatment. Basic investigations were done prior to therapy. All included patients received Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir), orally once daily at a fixed time with or without food for 12 weeks. Regular visits were arranged at 4, 8, and 12 weeks with easy access to the pediatric hepatology unit and the treating physician if any urgent problem in between the visits. Every visit, laboratory investigations were checked. Adverse events (after excluding other possible causes) were reported for the safety profile of the drug. The efficacy of the drug, HCV-RNA was assessed by quantitative real-time PCR at 4 weeks and after the end of the treatment course (12 weeks)

Trial Locations (1)

Unknown

Mansoura University Children Hospital, Al Mansurah

All Listed Sponsors
lead

Mansoura University Children Hospital

OTHER

NCT05091008 - Treatment of Chronic Hepatitis C Infection by Ledipasvir/Sofosbuvir in Naïve Children | Biotech Hunter | Biotech Hunter