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

September 15, 2019 updated by: Mostafa M. Sira, National Liver Institute, Egypt

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The WHO has declared hepatitis C a global health problem, with ∼ 3% of the world's population (roughly 170-200 million individuals) infected with HCV. Egypt has the highest prevalence of HCV in the world, ranging from 6 to 28%, with an average of ∼ 13.8% in the general population. Ap-proximately 90% of Egyptian HCV isolates belong to a single subtype, 4a.

Hepatitis C virus (HCV) is a major cause of chronic liver disease and a prin-cipal reason for liver transplant; approximately 170 million people worldwide are chronically infected. There is general consensus that HCV elimination is associated with strong and sustained CD4+ and CD8+ T cell res-ponses that target multiple epitopes within the different HCV proteins, however, they are not maintained in patients who develop chronic disease . A variety of factors purportedly contribute to the dimi-nished T cell responses observed in chronically infected patients, including an im-paired dendritic cell (DC) function.

The successful development of direct-acting antivirals (DAAs) that are active against hepatitis C virus has transformed chronic hepatitis C infection from a con-dition requiring complex therapies with unsatisfactory outcomes to one that can be easily treated with few contraindications and side-effects. Since 2011, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved eight oral DAA regimens for the treatment of adults with chronic hepatitis C. Investigation into DAAs for children has been slower.

For adolescents aged 12-17 years, the safety and efficacy of the fixed-dose combination sofosbuvir and ledipasvir for genotype 1 or 4 infection and of combination sofosbuvir plus ribavirin for genotype 2 or 3 infection have been described in full-length articles.

A recent study explored the safety and efficacy of combination sofosbuvirplus ribavirin in Pakistani children (aged 5-18 years) with hepatitis C virus genotype 1, 2, or 3 infection. Further results have been presented as ab-stracts for the fixed-dose combination sofosbuvir and ledipasvir in children aged 6-11 years for the fixed-dose combination ombitasvir, pari-taprevir, and ritonavir with or without dasabuvir and with or without ribavirin in adolescents aged 12-17 years with genotype 1 or 4 infection and for combination sofosbuvir plus daclatasvir with or without ribavirin in Egyp-tian adolescents aged 12-17 years with genotype 4 infection.

Dendritic cells are professional antigen presenting cells characterized by a po-tent capacity to elicit primary T cell responses. Two major subsets of DC can be identified from human peripheral blood: plasmacytoid (p) DC and conventional or myeloid (m) DC. Each subset represents 0.3-0.5% of the normal human peripheral blood mononuclear cell (PBMC) population.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Menofiya
      • Shebin El-Koom, Menofiya, Egypt, 32511
        • Pediatric Hepatology, Gastroenterology and Nutrition Department, National Liver Institute, Menoufia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children with chronic HCV
  • age 3- 12 y old
  • weight 17- 35kg
  • Basal HCV viremia less than 6.8 log IU/mL
  • Treatment-naive
  • No cirrhosis

Exclusion Criteria:

  • Patients with dual HBV and HCV infection or associated with chronic hepatitis other than chronic HCV
  • age below 3 years or above 12 years
  • body weight less than 17 or more than 35 Kg
  • HCV/HIV coinfection.
  • Patients with HCV infection and HCC.
  • Patients with HCV infection and underlying cardiac comorbidities
  • Decompensated patients with HCV
  • Hypoalbuminemia of < 3.5g/dL.
  • International normalised ratio (INR) >2.
  • Advanced fibrosis scoring by transient elastography (F 4 broScan)
  • Any concomitant malignancy.
  • Parents' refusal for participation of their children in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sofosbovir/Ledipasvir Daily
Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks
Drug: Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)
Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effect 1 Number of patients with fatigue
Time Frame: 8 weeks
Number of patients with fatigue
8 weeks
Side effect 2 Number of patients with Headache
Time Frame: 8 weeks
Number of patients with Headache
8 weeks
Side effect 3 Number of patients with nausea
Time Frame: 8 weeks
Number of patients with nausea
8 weeks
Side effect 4 Number of patients with diarrhea
Time Frame: 8 weeks
Number of patients with diarrhea
8 weeks
Side effect 5 Number of patients with insomnia
Time Frame: 8 weeks
Number of patients with insomnia
8 weeks
Side effect 6 Number of patients with weakness
Time Frame: 8 weeks
Number of patients with weakness
8 weeks
Side effect 7 Number of patients with bradycardia
Time Frame: 8 weeks
Number of patients with bradycardia
8 weeks
Side effect 8 Number of patients with cough
Time Frame: 8 weeks
Number of patients with cough
8 weeks
Side effect 9 Number of patients with myalgia
Time Frame: 8 weeks
Number of patients with myalgia
8 weeks
Side effect 10 Number of patients with dysapnea
Time Frame: 8 weeks
Number of patients with dysapnea
8 weeks
Side effect 11 Number of patients with irritability
Time Frame: 8 weeks
Number of patients with irritability
8 weeks
Side effect 12 Number of patients with dizziness
Time Frame: 8 weeks
Number of patients with dizziness
8 weeks
Side effect 13 Number of patients with depression
Time Frame: 8 weeks
Number of patients with depression
8 weeks
Side effect 14 Number of patients with skin rash
Time Frame: 8 weeks
Number of patients with skin rash
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCV-RNA PCR by the end of therapy
Time Frame: 8 weeks
HCV-RNA PCR at week 8
8 weeks
HCV-RNA PCR after 20 weeks for SVR
Time Frame: 20 weeks
HCV-RNA PCR at week 20
20 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment safety-1 Alanine transaminase serum level
Time Frame: 8 weeks
Alanine transaminase serum level
8 weeks
Treatment safety-2 Aspartate transaminase serum level
Time Frame: 8 weeks
Aspartate transaminase serum level
8 weeks
Treatment safety-2 Degree of liver fibrosis
Time Frame: 8 weeks
Liver Stiffness measurement before and after end of therapy
8 weeks
Treatment tolerability-1 Patient height
Time Frame: 20 weeks
measurement of Height
20 weeks
Treatment tolerability-2 Body weight
Time Frame: 20 weeks
measurement of weight
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Liver Institute, Egypt

Investigators

  • Principal Investigator: Behairy E Behairy, Prof, National Liver Institute, Menoufia University
  • Study Director: Hanaa A El-Araby, Prof, National Liver Institute, Menoufia University
  • Study Director: Mohamed A El-Guindi, Prof, National Liver Institute, Menoufia University
  • Study Chair: Hosam M Basiouny, MD, National Liver Institute, Menoufia University
  • Study Chair: Ola A Fouad, MD, National Liver Institute, Menoufia University
  • Study Chair: Ayman M Marey, Prof, Faculty of medicine, Zagazig university
  • Study Chair: Bassam A Ayoub, MD, National Liver Institute, Menoufia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2018

Primary Completion (Actual)

July 2, 2019

Study Completion (Actual)

July 2, 2019

Study Registration Dates

First Submitted

November 28, 2018

First Submitted That Met QC Criteria

December 4, 2018

First Posted (Actual)

December 5, 2018

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 15, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sof-Led-HCV-Ped

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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