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

Hepatitis C Genotype 4 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080415
• Other study ID #: DCV SOF T 2017
• Status: Completed
• Phase: Phase 3
• Start date: March 18, 2017
• Est. completion date: May 18, 2018

Study information

• Verified date: June 2018
• Source: Yassin Abdelghaffar Charity Center for Liver Disease and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 18, 2018
• Est. primary completion date: February 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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,..)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Genotype 4

Intervention

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

Locations

Country	Name	City	State
Egypt	Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research	Nasr City	Cairo

Sponsors (3)

Lead Sponsor	Collaborator
Yassin Abdelghaffar Charity Center for Liver Disease and Research	Egyptian Cure Bank NGO, Society of Friends of Liver Patients in the Arab World (SLPAW)

Country where clinical trial is conducted

Egypt, 

References & Publications (11)

(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

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. — View 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. Review. — View 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. — View 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. Review. — View Citation

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. Review. — View Citation

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. Review. — View 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. Epub 2000 Aug 17. — View 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. — View 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. Review. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.