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

Sponsor
National Liver Institute, Egypt (Other)
Overall Status
Completed
CT.gov ID
NCT03764345
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
6.8
Actual Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Sofosbovir/Ledipasvir in HCV Infected Children Aged From 4 to 10 Years
Actual Study Start Date :
Dec 6, 2018
Actual Primary Completion Date :
Jul 2, 2019
Actual Study Completion Date :
Jul 2, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Side effect 1 Number of patients with fatigue [8 weeks]

    Number of patients with fatigue

  2. Side effect 2 Number of patients with Headache [8 weeks]

    Number of patients with Headache

  3. Side effect 3 Number of patients with nausea [8 weeks]

    Number of patients with nausea

  4. Side effect 4 Number of patients with diarrhea [8 weeks]

    Number of patients with diarrhea

  5. Side effect 5 Number of patients with insomnia [8 weeks]

    Number of patients with insomnia

  6. Side effect 6 Number of patients with weakness [8 weeks]

    Number of patients with weakness

  7. Side effect 7 Number of patients with bradycardia [8 weeks]

    Number of patients with bradycardia

  8. Side effect 8 Number of patients with cough [8 weeks]

    Number of patients with cough

  9. Side effect 9 Number of patients with myalgia [8 weeks]

    Number of patients with myalgia

  10. Side effect 10 Number of patients with dysapnea [8 weeks]

    Number of patients with dysapnea

  11. Side effect 11 Number of patients with irritability [8 weeks]

    Number of patients with irritability

  12. Side effect 12 Number of patients with dizziness [8 weeks]

    Number of patients with dizziness

  13. Side effect 13 Number of patients with depression [8 weeks]

    Number of patients with depression

  14. Side effect 14 Number of patients with skin rash [8 weeks]

    Number of patients with skin rash

Secondary Outcome Measures

  1. HCV-RNA PCR by the end of therapy [8 weeks]

    HCV-RNA PCR at week 8

  2. HCV-RNA PCR after 20 weeks for SVR [20 weeks]

    HCV-RNA PCR at week 20

Other Outcome Measures

  1. Treatment safety-1 Alanine transaminase serum level [8 weeks]

    Alanine transaminase serum level

  2. Treatment safety-2 Aspartate transaminase serum level [8 weeks]

    Aspartate transaminase serum level

  3. Treatment safety-2 Degree of liver fibrosis [8 weeks]

    Liver Stiffness measurement before and after end of therapy

  4. Treatment tolerability-1 Patient height [20 weeks]

    measurement of Height

  5. Treatment tolerability-2 Body weight [20 weeks]

    measurement of weight

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pediatric Hepatology, Gastroenterology and Nutrition Department, National Liver Institute, Menoufia University Shebin El-Koom Menofiya Egypt 32511

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mostafa M. Sira, Assistant Professor, National Liver Institute, Egypt
ClinicalTrials.gov Identifier:
NCT03764345
Other Study ID Numbers:
  • Sof-Led-HCV-Ped
First Posted:
Dec 5, 2018
Last Update Posted:
Sep 17, 2019
Last Verified:
Sep 1, 2019
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
Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic

Study Results

No Results Posted as of Sep 17, 2019