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Treatment of Egyptian Hepatitis C Genotype 4 Infected Children (and Adolescents) With Combined Sofosbuvir & Daclatasvir

Sponsor
Yassin Abdelghaffar Charity Center for Liver Disease and Research (Other)
Overall Status
Completed
CT.gov ID
NCT03080415
Collaborator
Egyptian Cure Bank (Other), Society of Friends of Liver Patients in the Arab World (SLPAW) (Other)
40
Enrollment
1
Location
1
Arm
14
Actual Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open, uncontrolled pilot study of thirty chronic HCV infected patients carried out at Yassin Abdel Ghaffar Charity Center for Liver Disease and Research. The aim of this study is to investigate the safety & efficacy of combined therapy sofosbuvir (SOF) and daclatasvir (DCV) for treating HCV Genotype 4 in children aged 8 to 18. Due to previous positive results in other clinical studies of this drug it is expected that the drug will have high safety and high efficacy. Safety will be measured by checking for adverse effects, while efficacy will be measured by Real-Time Quantitative Polymerase Chain Reaction (qPCR) detecting viral nucleic acids in blood samples.

Condition or Disease Intervention/Treatment Phase
  • Drug: Combined Therapy SOF and DCV
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All of the participants will be receiving combined therapy of sofosbuvir and daclatasvir for 12 weeks.All of the participants will be receiving combined therapy of sofosbuvir and daclatasvir for 12 weeks.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Safety and Efficacy of Sofosbuvir & Daclatasvir Combined Therapy for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4
Actual Study Start Date :
Mar 18, 2017
Actual Primary Completion Date :
Feb 18, 2018
Actual Study Completion Date :
May 18, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Combined Therapy SOF and DCV

Drug: Combined Therapy SOF and DCV
1 whole or half tablet sofosbuvir and 1 whole or half tablet daclatasvir per day SOF dosage: 400 mg/day for greater than 45 kg weight patients; 200 mg/day for 17 kg to 45 kg patients DCV dosage: 60 mg/day for greater than 45 kg weight patients; 30 mg for 17 kg to 45 kg patients
Other Names:
  • sofosbuvir
  • daclatasvir

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Treatment Emergent Adverse Events [During the 12 weeks of treatment.]

      The presence of any adverse effects will be used to characterize this outcome measure.

    2. Sustained Viral Clearance [At Week 12 after end of treatment.]

      HCV RNA qPCR will be used to determine if the target of viral clearance has been established. Detection limit of the kit is 12 IU/ml.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age: 8-18 years

    2. Sex: both sexes

    3. Naïve patients, with chronic HCV infection

    Exclusion Criteria:

    1. Co-infection with Hepatitis B virus (HBV)

    2. Other associated chronic liver illness

    3. Cirrhotic patients (as indicated by biopsy, fibroscan(F4)

    4. Patients with history of hematemesis (non cirrhotic portal hypertension)

    5. Patients on drugs known to interact unfavorably with SOF (Amiodarone,..)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research Nasr City Cairo Egypt

    Sponsors and Collaborators

    • Yassin Abdelghaffar Charity Center for Liver Disease and Research
    • Egyptian Cure Bank
    • Society of Friends of Liver Patients in the Arab World (SLPAW)

    Investigators

    • Principal Investigator: Tawhida Y. Abdel Ghaffar, M.D., Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr. Tawhida Yassin Abdel Ghaffar, Professor, Yassin Abdelghaffar Charity Center for Liver Disease and Research
    ClinicalTrials.gov Identifier:
    NCT03080415
    Other Study ID Numbers:
    • DCV SOF T 2017
    First Posted:
    Mar 15, 2017
    Last Update Posted:
    Jun 6, 2018
    Last Verified:
    Jun 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis
    Sofosbuvir

    Study Results

    No Results Posted as of Jun 6, 2018