Assessment Effects After Direct Acting Antiviral in Chronic Hepatitis c Virus Patients
Primary Purpose
Chronic Hepatitis c
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Sofosbuvir , daclatasvir
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis c
Eligibility Criteria
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. ـPatients with primary haematological abnormalities not related to chronic hepatitis C virus infection
- Experienced patients (previously failed treatment)
Sites / Locations
- Assuit
- Assuit
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
control group
Study group
Arm Description
oral tablets
sofosbuvir , daclatasvir oral tablets
Outcomes
Primary Outcome Measures
the percentage of patients with hematological changes
complete blood count and prothrombin time and concentration
The percentage of patients with antibodies against RBCs
Coomb's test
Secondary Outcome Measures
the percentage of patients with biochemical changes
Urea, creatinine,bilirubin,ALT,AST
The percentage of patients with antibodies against RBCs
Coomb's test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03163849
Brief Title
Assessment Effects After Direct Acting Antiviral in Chronic Hepatitis c Virus Patients
Official Title
Assessment of Haematological and Biochemical Effect After New Direct Acting Antiviral Drugs in Chronic Hepatitis c Virus Egyptian Patients in Assiut Province
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
In Egypt, Chronic hepatitis C virus is a serious health problem where Chronic hepatitis C virus prevalence is very high.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis c
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
oral tablets
Arm Title
Study group
Arm Type
Experimental
Arm Description
sofosbuvir , daclatasvir oral tablets
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir , daclatasvir
Intervention Description
Tablets
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
oral tablets
Primary Outcome Measure Information:
Title
the percentage of patients with hematological changes
Description
complete blood count and prothrombin time and concentration
Time Frame
12 weeks
Title
The percentage of patients with antibodies against RBCs
Description
Coomb's test
Time Frame
Pre treatment
Secondary Outcome Measure Information:
Title
the percentage of patients with biochemical changes
Description
Urea, creatinine,bilirubin,ALT,AST
Time Frame
12 weeks
Title
The percentage of patients with antibodies against RBCs
Description
Coomb's test
Time Frame
Three months after the end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. ـPatients with primary haematological abnormalities not related to chronic hepatitis C virus infection
Experienced patients (previously failed treatment)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar Ali, Master Degree
Organizational Affiliation
Internal medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assuit
City
Assiut
State/Province
Assuit
Country
Egypt
Facility Name
Assuit
City
Assuit
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18022726
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. doi: 10.1016/j.jhep.2007.07.033. Epub 2007 Nov 5.
Results Reference
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PubMed Identifier
19207969
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.
Results Reference
background
PubMed Identifier
1296960
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.
Results Reference
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PubMed Identifier
21196607
Citation
Fallahian F, Najafi A. Epidemiology of hepatitis C in the Middle East. Saudi J Kidney Dis Transpl. 2011 Jan;22(1):1-9.
Results Reference
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PubMed Identifier
10072408
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. doi: 10.1056/NEJM199903113401001.
Results Reference
background
PubMed Identifier
12682882
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. doi: 10.1053/jlts.2003.50073.
Results Reference
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PubMed Identifier
17164125
Citation
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.
Results Reference
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PubMed Identifier
25640363
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. doi: 10.7314/apjcp.2015.16.1.265.
Results Reference
background
PubMed Identifier
21221855
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.
Results Reference
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PubMed Identifier
26473914
Citation
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.
Results Reference
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Assessment Effects After Direct Acting Antiviral in Chronic Hepatitis c Virus Patients
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