Back to resultsHydroxychloroquine Efficacy on Behcet's Disease Thrombosis
Primary Purpose
Behcet's Syndrome, Vascular Type
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hydroxychloroquine
Sponsored by
About this trial
This is an interventional prevention trial for Behcet's Syndrome, Vascular Type
Eligibility Criteria
Inclusion Criteria:
- All patients diagnosed with Behcet's disease on any DMARDs
Exclusion Criteria:
- Patients with critical conditions
- Patients with hypersensitivity or adverse drug reactions to hydroxychloroquine.
Sites / Locations
- Assiut University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hydroxychloroquine arm
Arm Description
Outcomes
Primary Outcome Measures
Prevention of the recurrence of thrombotic events
number of relapses is expected to fall with the longterm use of the drug
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04022421
Brief Title
Hydroxychloroquine Efficacy on Behcet's Disease Thrombosis
Official Title
The Efficacy of Hydroxychloroquine on Behcet's Disease Thrombotic Events Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
October 2019 (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
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Patients diagnosed with Behcet's disease will be randomized to administeration of hydroxychloroquine. Assessment will be done for the patients at baseline and every one month in the first three months and then quarterly for one year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behcet's Syndrome, Vascular Type
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hydroxychloroquine arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Description
the drug will be taken by one group of the patients daily at a dose of 400mg
Primary Outcome Measure Information:
Title
Prevention of the recurrence of thrombotic events
Description
number of relapses is expected to fall with the longterm use of the drug
Time Frame
6 months- one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients diagnosed with Behcet's disease on any DMARDs
Exclusion Criteria:
Patients with critical conditions
Patients with hypersensitivity or adverse drug reactions to hydroxychloroquine.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa Mohamed, Post-doctor
Phone
+20882413177
Email
a.a.a.mohamed@aun.edu.eg
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alaa Mohamed
Phone
+201018554227
Email
a.a.a.mohamed@aun.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Hydroxychloroquine Efficacy on Behcet's Disease Thrombosis
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