search
Back to results

Hydroxychloroquine 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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Behcet's Syndrome, Vascular Type

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 15, 2019
Last Updated
July 23, 2019
Sponsor
Assiut University
search

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

We'll reach out to this number within 24 hrs