CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)drug
Likely dose
Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03764345
NCT03764345N/ACompleted
CompareCT.gov

Sofosbovir/Ledipasvir in HCV Infected Children Aged From 4 to 10 Years

National Liver Institute, Egypt·interventional·Posted Dec 5, 2018·Updated Sep 17, 2019

In Brief

A clinical study evaluating Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir) for Hepatitis C, Chronic and Children, Only. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Recently the era of direct-acting antiviral drugs for hepatitis C treatment has changed the world map of HCV. Results in adults are promising. FDA approved only two drugs in the pediatric age group 12 to 17 years. Younger children are still on the wait list for treatment. The current study aimed to treat children aged between 3 and 12 years with half the adult dose of Sofosbuvir/Ledipasvir combination (Heterosofir).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic, Children, Only
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedDec 5, 2018
Enrollment StartDec 6, 2018
Primary CompletionJul 2, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.6 years ago

Interventions

Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)drug

Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks