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

Primary Purpose

Hepatitis C Genotype 4

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Combined Therapy SOF and DCV
Sponsored by
Yassin Abdelghaffar Charity Center for Liver Disease and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Genotype 4

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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,..)

Sites / Locations

  • Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combined Therapy SOF and DCV

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Treatment Emergent Adverse Events
The presence of any adverse effects will be used to characterize this outcome measure.
Sustained Viral Clearance
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.

Secondary Outcome Measures

Full Information

First Posted
February 22, 2017
Last Updated
June 3, 2018
Sponsor
Yassin Abdelghaffar Charity Center for Liver Disease and Research
Collaborators
Egyptian Cure Bank, Society of Friends of Liver Patients in the Arab World (SLPAW)
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1. Study Identification

Unique Protocol Identification Number
NCT03080415
Brief Title
Treatment of Egyptian Hepatitis C Genotype 4 Infected Children (and Adolescents) With Combined Sofosbuvir & Daclatasvir
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 18, 2017 (Actual)
Primary Completion Date
February 18, 2018 (Actual)
Study Completion Date
May 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yassin Abdelghaffar Charity Center for Liver Disease and Research
Collaborators
Egyptian Cure Bank, Society of Friends of Liver Patients in the Arab World (SLPAW)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Genotype 4

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
All of the participants will be receiving combined therapy of sofosbuvir and daclatasvir for 12 weeks.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined Therapy SOF and DCV
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Combined Therapy SOF and DCV
Other Intervention Name(s)
sofosbuvir, daclatasvir
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events
Description
The presence of any adverse effects will be used to characterize this outcome measure.
Time Frame
During the 12 weeks of treatment.
Title
Sustained Viral Clearance
Description
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.
Time Frame
At Week 12 after end of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 8-18 years Sex: both sexes Naïve patients, with chronic HCV infection Exclusion Criteria: Co-infection with Hepatitis B virus (HBV) Other associated chronic liver illness Cirrhotic patients (as indicated by biopsy, fibroscan(F4) Patients with history of hematemesis (non cirrhotic portal hypertension) Patients on drugs known to interact unfavorably with SOF (Amiodarone,..)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tawhida Y. Abdel Ghaffar, M.D.
Organizational Affiliation
Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research
City
Nasr City
State/Province
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23172780
Citation
Mohd Hanafiah K, Groeger J, Flaxman AD, Wiersma ST. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology. 2013 Apr;57(4):1333-42. doi: 10.1002/hep.26141. Epub 2013 Feb 4.
Results Reference
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PubMed Identifier
24251930
Citation
Wantuck JM, Ahmed A, Nguyen MH. Review article: the epidemiology and therapy of chronic hepatitis C genotypes 4, 5 and 6. Aliment Pharmacol Ther. 2014 Jan;39(2):137-47. doi: 10.1111/apt.12551. Epub 2013 Nov 19.
Results Reference
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PubMed Identifier
25069599
Citation
Messina JP, Humphreys I, Flaxman A, Brown A, Cooke GS, Pybus OG, Barnes E. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology. 2015 Jan;61(1):77-87. doi: 10.1002/hep.27259. Epub 2014 Jul 28.
Results Reference
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PubMed Identifier
25086286
Citation
Gower E, Estes C, Blach S, Razavi-Shearer K, Razavi H. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol. 2014 Nov;61(1 Suppl):S45-57. doi: 10.1016/j.jhep.2014.07.027. Epub 2014 Jul 30.
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PubMed Identifier
10950762
Citation
Ray SC, Arthur RR, Carella A, Bukh J, Thomas DL. Genetic epidemiology of hepatitis C virus throughout egypt. J Infect Dis. 2000 Sep;182(3):698-707. doi: 10.1086/315786. Epub 2000 Aug 17.
Results Reference
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PubMed Identifier
24865321
Citation
Reker C, Islam KM. Risk factors associated with high prevalence rates of hepatitis C infection in Egypt. Int J Infect Dis. 2014 Aug;25:104-6. doi: 10.1016/j.ijid.2014.02.003. Epub 2014 May 24.
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PubMed Identifier
20708181
Citation
Zahran KM, Badary MS, Agban MN, Abdel Aziz NH. Pattern of hepatitis virus infection among pregnant women and their newborns at the Women's Health Center of Assiut University, Upper Egypt. Int J Gynaecol Obstet. 2010 Nov;111(2):171-4. doi: 10.1016/j.ijgo.2010.06.013. Epub 2010 Aug 12.
Results Reference
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PubMed Identifier
24782620
Citation
El Naghi S, Abdel-Ghaffar TY, El-Karaksy H, Abdel-Aty EF, El-Raziky MS, Allam AA, Helmy H, El-Araby HA, Behairy BE, El-Guindi MA, El-Sebaie H, Abdel-Ghaffar AY, Ehsan NA, El-Hennawy AM, Sira MM. Safety and efficacy of Hansenula-derived PEGylated-interferon alpha-2a and ribavirin combination in chronic hepatitis C Egyptian children. World J Gastroenterol. 2014 Apr 28;20(16):4681-91. doi: 10.3748/wjg.v20.i16.4681.
Results Reference
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Citation
(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
Results Reference
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Citation
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Citation
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Results Reference
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Treatment of Egyptian Hepatitis C Genotype 4 Infected Children (and Adolescents) With Combined Sofosbuvir & Daclatasvir

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