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

NCT03080415 | Completed Phase 3

• 1 other identifier: DCV SOF T 2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C Genotype 4

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment Emergent Adverse Events

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

  During the 12 weeks of treatment.

• 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.

  At Week 12 after end of treatment.

Study Arms (1)

Combined Therapy SOF and DCV

EXPERIMENTAL

Drug: Combined Therapy SOF and DCV

Interventions

Combined Therapy SOF and DCV DRUG

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

Also known as: sofosbuvir, daclatasvir

Combined Therapy SOF and DCV

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: 8-18 years
• Sex: both sexes
• Naïve patients, with chronic HCV infection

You may not qualify if:

• 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,..)

Sponsors & Collaborators

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

Study Sites (1)

Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research

Madīnat an Naşr, Cairo Governorate, Egypt

Location

Related Publications (11)

• 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.

  PMID: 23172780 BACKGROUND

• 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.

  PMID: 24251930 BACKGROUND

• 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.

  PMID: 25069599 BACKGROUND

• 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.

  PMID: 25086286 BACKGROUND

• 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.

  PMID: 10950762 BACKGROUND

• 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.

  PMID: 24865321 BACKGROUND

• 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.

  PMID: 20708181 BACKGROUND

• 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.

  PMID: 24782620 BACKGROUND

• (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

  BACKGROUND

• Peter J, Nelson DR. Optimal interferon-free therapy in treatment-experienced chronic hepatitis C patients. Liver Int. 2015 Jan;35 Suppl 1:65-70. doi: 10.1111/liv.12718.

  PMID: 25529089 BACKGROUND

• Papastergiou V, Karatapanis S. Current status and emerging challenges in the treatment of hepatitis C virus genotypes 4 to 6. World J Clin Cases. 2015 Mar 16;3(3):210-20. doi: 10.12998/wjcc.v3.i3.210.

  PMID: 25789294 BACKGROUND

MeSH Terms

Interventions

daclatasvir; Sofosbuvir

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Tawhida Y. Abdel Ghaffar, M.D.

  Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All of the participants will be receiving combined therapy of sofosbuvir and daclatasvir for 12 weeks.

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 15, 2017
• Study Start: March 18, 2017
• Primary Completion: February 18, 2018
• Study Completion: May 18, 2018
• Last Updated: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)