Assessment Effects After Direct Acting Antiviral in Chronic Hepatitis c Virus Patients
NCT ID: NCT03163849
Last Updated: 2019-09-12
Study Results
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Basic Information
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UNKNOWN
PHASE3
50 participants
INTERVENTIONAL
2019-09-01
2020-07-30
Brief Summary
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Detailed Description
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Chronic Chronic hepatitis C virus infection is associated with a high risk for liver-related mortality because of a variety of complications, which appear obviously in those patients with developing end-stage liver disease, including decompensated liver cirrhosis and hepatocellular carcinoma. Egypt had the highest burden of deaths from Chronic hepatitis C virus-associated hepatocellular carcinoma in the Arab world, around sixty three percentage of all Chronic hepatitis C virus-associated hepatocellular carcinoma deaths happened in Egypt.
Poor response rates and poor tolerability were observed during treatment of chronic Chronic hepatitis C virus infection with pegylated interferon and ribavirin.
Because Chronic hepatitis C virus does not incorporate into the human genome and must replicate to maintain infection, it should be potential to destroy the virus completely by blocking replication at one or more stages of the life cycle.
In recent years, there has been a shift in treatment paradigm with the discovery and approval of agents that target specific proteins vital for hepatitis C replication. The Non Structural 3/4A inhibitors simeprevir and paritaprevir, the NonStructural 5A inhibitors ombitasvir, ledipasvir, and daclatasvir, and the Non Structural 5B inhibitors sofosbuvir and dasabuvir have been approved and incorporated as first-line agents into the latest guidelines for Hepatitis C treatment. Used in combination, these agents produce higher rates of sustained virologic response and less adverse effects than historical options, along with limited rates of resistance.
In previous studies ,haematological side effect of interferon and Ribavirin was reported in the form of reduction in Haemoglobin ,White Blood Cells and asymptomatic thrombocytopenia While SOF based combination therapy improved the liver function, anemia ,leucopenia and thrombocytopenia were detected especially after treatment with SOF,RBV and PegINF alpha .also significant improvement in the level of ALT and AST post treatment with either SOF and RBV or SOF ,RBV and INF were detected as compaired to baseline While no significant differences were detected on the level of total bilirubin or creatinine In our study we will assess and evaluate many biochemical and hematological findings upon new direct acting antiviral agents in Egyptian chronic hepatitis C virus patients
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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control group
oral tablets
Placebos
oral tablets
Study group
sofosbuvir , daclatasvir oral tablets
Sofosbuvir , daclatasvir
Tablets
Interventions
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Sofosbuvir , daclatasvir
Tablets
Placebos
oral tablets
Eligibility Criteria
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Inclusion Criteria
* Patients with chronic Hepatitis C virus who are candidates for Direct Acting Antiviral Therapy:
* Age is from 18 to 65 years.
Exclusion Criteria
* Post-Liver Transplant Patients. ـPatients with primary haematological abnormalities not related to chronic hepatitis C virus infection
* Experienced patients (previously failed treatment)
18 Years
65 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Sahar Ezeldeen Hussein Ali
Principal investigator
Principal Investigators
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Sahar Ali, Master Degree
Role: PRINCIPAL_INVESTIGATOR
Internal medicine
Locations
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Assuit
Asyut, Assuit, Egypt
Assuit
Asyut, , Egypt
Countries
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References
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Esteban JI, Sauleda S, Quer J. The changing epidemiology of hepatitis C virus infection in Europe. J Hepatol. 2008 Jan;48(1):148-62. doi: 10.1016/j.jhep.2007.07.033. Epub 2007 Nov 5.
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.
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.
Fallahian F, Najafi A. Epidemiology of hepatitis C in the Middle East. Saudi J Kidney Dis Transpl. 2011 Jan;22(1):1-9.
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. doi: 10.1056/NEJM199903113401001.
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. doi: 10.1053/jlts.2003.50073.
Verna EC, Brown RS Jr. Hepatitis C virus and liver transplantation. Clin Liver Dis. 2006 Nov;10(4):919-40. doi: 10.1016/j.cld.2006.08.012.
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. doi: 10.7314/apjcp.2015.16.1.265.
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.
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.
Other Identifiers
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PRHCV
Identifier Type: -
Identifier Source: org_study_id
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