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Safety & Efficacy of Sofosbuvir 400mg/Ledipasvir 90mg in the Treatment of Chronic Hepatitis C Adolescents

NCT03343444 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-05-24

No results posted yet for this study

Summary

Randomized, open-label study in treatment naïve and treatment experienced, adolescence to determine the efficacy of Sofosbuvir 400mg/ledipasvir 90mg in treatment naïve and treatment-experienced adolescence. Hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (SVR12)

Conditions

  • Hepatitis C Virus Infection, Response to Therapy of

Interventions

DRUG

12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)

Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 12 weeks

DRUG

8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)

Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 8 weeks

Sponsors & Collaborators

  • Egyptian Liver Hospital

    lead OTHER

Principal Investigators

  • Gamal Shiha, MD · Egyptian Liver Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-04-15
Primary Completion
2018-11-01
Completion
2019-05-31

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 NCT03343444 on ClinicalTrials.gov