NCT02985281

Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Pediatric Patients

Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Daul Therapy in Egyptian Pediatric Patients With Chronic Hepatitis C Infection. A Prospective, Randomized, Multicenter Study

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: National Liver Institute, Egypt · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Egyptian Pediatric Patients With Chronic Hepatitis C Infection aged 10- 18 years old.

Detailed description

Male or female child ≥ 10 years and ≤ 18 years of age chronically infected with hepatitis C virus, willing and able to complete all study visits and procedures. Acceptance from the parents will be recruited for giving a verbal and written informed consent. Patient with childs Pugh class B or C, compensated cirrhosis may be enrolled. Patient with cirrhosis with their alpha fetoprotein is more than 100 ng/ml and patient with coinfection of Hepatitis B virus or HIV will be excluded. Participation in the study procedures is anticipated to last up to 40 weeks including a screening and eligibility assessment phase (4 weeks duration), a 24- week treatment phase, and 12- week post treatment follow up phase. A detailed treatment log of the returned investigational product will be established with the investigator (or the pharmacist) and countersigned by the investigator and the monitoring team. Compliance is assessed by counting the number of returned tablets at each visit. A discontinuation is defined as a period with at least seven consecutive days without study drug intake. Safety and efficacy will be compared between cirrhotic versus non-cirrhotic subjects in multivariate model to test the impact of this pretreatment characteristic on safety, tolerability and efficacy endpoints. Safety analysis:clinical adverse events will be displayed by body system (soc) for each study subject and by treatment group, using MedDRA coding. Summary of statistics of safety and efficacy endpoints will be displayed by stratification parameters.

Conditions

• Pharmacological Action

Interventions

Type	Name	Description
DRUG	Sofosbuvir Oral Product	direct acting antiviral drug for HCV infection
DRUG	Ribavirin	antiviral drug for HCV infection

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-06-01
• Completion: 2017-09-01
• First posted: 2016-12-07
• Last updated: 2016-12-19

Locations

1 site across 1 country: Egypt