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

NCT02985281 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2016-12-19

No results posted yet for this study

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.

Conditions

  • Pharmacological Action

Interventions

DRUG

Sofosbuvir Oral Product

direct acting antiviral drug for HCV infection

DRUG

Ribavirin

antiviral drug for HCV infection

Sponsors & Collaborators

  • Pharco Pharmaceuticals

    collaborator INDUSTRY

  • National Liver Institute, Egypt

    lead OTHER

Principal Investigators

  • Behairy Behairy, professor · National Liver Institute, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-06-30
Completion
2017-09-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02985281 on ClinicalTrials.gov