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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03080415
Recruitment Status : Completed
First Posted : March 15, 2017
Last Update Posted : June 6, 2018
Sponsor:
Collaborators:
Egyptian Cure Bank
Society of Friends of Liver Patients in the Arab World (SLPAW)
Information provided by (Responsible Party):
Dr. Tawhida Yassin Abdel Ghaffar, Yassin Abdelghaffar Charity Center for Liver Disease and Research

Study Description
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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
Hepatitis C Genotype 4 Drug: Combined Therapy SOF and DCV Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
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.
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 : March 18, 2017
Actual Primary Completion Date : February 18, 2018
Actual Study Completion Date : May 18, 2018

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events [ Time Frame: During the 12 weeks of treatment. ]
    The presence of any adverse effects will be used to characterize this outcome measure.

  2. Sustained Viral Clearance [ Time Frame: 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
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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080415


Locations
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Egypt
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
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Principal Investigator: Tawhida Y. Abdel Ghaffar, M.D. Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research
More Information
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Publications:
(CDER) USDoHaHSFaDACfDEaR. Guidance for Industry Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment 2013. Available from: http://www.fda. gov/downloads/drugs/guidancecomplianceregulatoryinformation/ guidances/ucm225333.pdf

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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: March 15, 2017    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents