Treatment of Egyptian Hepatitis C Genotype 4 Infected Children (and Adolescents) With Combined Sofosbuvir & Daclatasvir
NCT ID: NCT03080415
Last Updated: 2018-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
40 participants
INTERVENTIONAL
2017-03-18
2018-05-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Combined Therapy SOF and DCV
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Sex: both sexes
3. Naïve patients, with chronic HCV infection
Exclusion Criteria
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,..)
8 Years
18 Years
ALL
No
Sponsors
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Egyptian Cure Bank
OTHER
Society of Friends of Liver Patients in the Arab World (SLPAW)
UNKNOWN
Yassin Abdelghaffar Charity Center for Liver Disease and Research
OTHER
Responsible Party
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Dr. Tawhida Yassin Abdel Ghaffar
Professor
Principal Investigators
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Tawhida Y. Abdel Ghaffar, M.D.
Role: PRINCIPAL_INVESTIGATOR
Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research
Locations
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Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research
Madīnat an Naşr, Cairo Governorate, Egypt
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
(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
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.
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.
Other Identifiers
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DCV SOF T 2017
Identifier Type: -
Identifier Source: org_study_id
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