Chronic Hepatitis c Clinical Trial
Official title:
Assessment of Haematological and Biochemical Effect After New Direct Acting Antiviral Drugs in Chronic Hepatitis c Virus Egyptian Patients in Assiut Province
Verified date | September 2019 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Chronic hepatitis C virus infection affects an estimated one hundred and seventy million people around the world with and approximate prevalence 0.2-2 % in the United State of America and European countries.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | July 30, 2020 |
Est. primary completion date | June 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Our study proposed for all consented patients complaining from chronic Hepatitis C virus infection undergoing treatment with antiviral drugs is possible through certain indications or criteria as follow: - Patients with chronic Hepatitis C virus who are candidates for Direct Acting Antiviral Therapy: - Age is from 18 to 65 years. Exclusion Criteria: - Those patients with chronic Hepatitis C virus infection are impossible or contraindicated to be treated with antiviral drugs as follow: - Geriatrics (> 65 years of age): - Pediatrics (< 18 years of age): - patients with known hypersensitivity to any of the components of the antiviral drug. - Post-Liver Transplant Patients. ?Patients with primary haematological abnormalities not related to chronic hepatitis C virus infection - Experienced patients (previously failed treatment) |
Country | Name | City | State |
---|---|---|---|
Egypt | Assuit | Assiut | Assuit |
Egypt | Assuit | Assuit |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Chayama K, Hayes CN. HCV Drug Resistance Challenges in Japan: The Role of Pre-Existing Variants and Emerging Resistant Strains in Direct Acting Antiviral Therapy. Viruses. 2015 Oct 13;7(10):5328-42. doi: 10.3390/v7102876. Review. — View Citation
Darwish NM, Abbas MO, Abdelfattah FM, Darwish MA. Hepatitis C virus infection in blood donors in Egypt. J Egypt Public Health Assoc. 1992;67(3-4):223-36. — View Citation
Davis GL, Albright JE, Cook SF, Rosenberg DM. Projecting future complications of chronic hepatitis C in the United States. Liver Transpl. 2003 Apr;9(4):331-8. — View Citation
El-Serag HB, Mason AC. Rising incidence of hepatocellular carcinoma in the United States. N Engl J Med. 1999 Mar 11;340(10):745-50. — View Citation
Esteban JI, Sauleda S, Quer J. The changing epidemiology of hepatitis C virus infection in Europe. J Hepatol. 2008 Jan;48(1):148-62. Epub 2007 Nov 5. Review. — View Citation
Fallahian F, Najafi A. Epidemiology of hepatitis C in the Middle East. Saudi J Kidney Dis Transpl. 2011 Jan;22(1):1-9. Review. — View Citation
Khan G, Hashim MJ. Burden of virus-associated liver cancer in the Arab world, 1990-2010. Asian Pac J Cancer Prev. 2015;16(1):265-70. — View Citation
Lavanchy D. The global burden of hepatitis C. Liver Int. 2009 Jan;29 Suppl 1:74-81. doi: 10.1111/j.1478-3231.2008.01934.x. Review. — View Citation
Operskalski EA, Kovacs A. HIV/HCV co-infection: pathogenesis, clinical complications, treatment, and new therapeutic technologies. Curr HIV/AIDS Rep. 2011 Mar;8(1):12-22. doi: 10.1007/s11904-010-0071-3. Review. — View Citation
Verna EC, Brown RS Jr. Hepatitis C virus and liver transplantation. Clin Liver Dis. 2006 Nov;10(4):919-40. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the percentage of patients with hematological changes | complete blood count and prothrombin time and concentration | 12 weeks | |
Primary | The percentage of patients with antibodies against RBCs | Coomb's test | Pre treatment | |
Secondary | the percentage of patients with biochemical changes | Urea, creatinine,bilirubin,ALT,AST | 12 weeks | |
Secondary | The percentage of patients with antibodies against RBCs | Coomb's test | Three months after the end of treatment |
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