Back to resultsPharmacogentic Screening of Coumarine Based Oral Anticoagulant Using Next Generation Seguencer
Primary Purpose
Thrombosis
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Genetic Mutations
Sponsored by
About this trial
This is an interventional diagnostic trial for Thrombosis
Eligibility Criteria
Inclusion Criteria:
- Patients with thrombosis and warfarin resistance
Exclusion Criteria:
- less than 18 years
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Warfarin resistant patients
Control
Arm Description
Genetic Mutations
Genetic Mutations
Outcomes
Primary Outcome Measures
number of patients with genetic polymorphism
patients with abnormal polymorphisms
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03180567
Brief Title
Pharmacogentic Screening of Coumarine Based Oral Anticoagulant Using Next Generation Seguencer
Official Title
Pharmacogentic Screening of Coumarine Based Oral Anticoagulant Using Next Generation Seguencer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
As drug response is a complex trait in the majority of cases using an optimal starting dose for an individual may reduce the time taken to reach a stable INR, and reduce the risk of having either a high INR (with a risk of bleeding) or a low INR (with a risk of thrombosis)
Detailed Description
The results of this project will benefit in (1) Identification of novel features or mutation types in warfarin resistance genomes. (2) To determine whether other polymorphisms in noncoding regions or their unique haplotype combinations contribute to the variability in the maintenance dose of warfarin, and (3)personalization of the drug and deciding the correct dose from the start.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Warfarin resistant patients
Arm Type
Experimental
Arm Description
Genetic Mutations
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Genetic Mutations
Intervention Type
Diagnostic Test
Intervention Name(s)
Genetic Mutations
Intervention Description
By next generation sequencing
Primary Outcome Measure Information:
Title
number of patients with genetic polymorphism
Description
patients with abnormal polymorphisms
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with thrombosis and warfarin resistance
Exclusion Criteria:
less than 18 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr Gawaly, Ass Prof
Phone
01221793033
Email
amrgawaly1@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr Gawaly, Consultant
Organizational Affiliation
Hematology Dept. - Tanta University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Said Hammad Abdou, Prof
Organizational Affiliation
Clinical Pathology dept.- Tanta University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Enas Abdul-Raouf, Lecturer
Organizational Affiliation
Biology and Genetics- Tanta University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Abdelaziz Zidane, Lecturer
Organizational Affiliation
Genetics-Damanhour University
Official's Role
Study Chair
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Cairo
State/Province
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-elsalam, lecturer
Phone
00201000040794
Email
Sherif_tropical@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ahmed Elsharkawy, Ass. lect.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pharmacogentic Screening of Coumarine Based Oral Anticoagulant Using Next Generation Seguencer
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