- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04022421
Hydroxychloroquine Efficacy on Behcet's Disease Thrombosis
July 23, 2019 updated by: Alaa Abdelkhalik Ahmed Mohamed, Assiut University
The Efficacy of Hydroxychloroquine on Behcet's Disease Thrombotic Events Prevention
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alaa Mohamed, Post-doctor
- Phone Number: +20882413177
- Email: a.a.a.mohamed@aun.edu.eg
Study Locations
-
-
-
Assiut, Egypt
- Recruiting
- Assiut university hospital
-
Contact:
- Alaa Mohamed
- Phone Number: +201018554227
- Email: a.a.a.mohamed@aun.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: hydroxychloroquine arm
|
the drug will be taken by one group of the patients daily at a dose of 400mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevention of the recurrence of thrombotic events
Time Frame: 6 months- one year
|
number of relapses is expected to fall with the longterm use of the drug
|
6 months- one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Anticipated)
August 1, 2019
Study Completion (Anticipated)
October 1, 2019
Study Registration Dates
First Submitted
July 15, 2019
First Submitted That Met QC Criteria
July 15, 2019
First Posted (Actual)
July 17, 2019
Study Record Updates
Last Update Posted (Actual)
July 25, 2019
Last Update Submitted That Met QC Criteria
July 23, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Eye Diseases
- Genetic Diseases, Inborn
- Stomatognathic Diseases
- Mouth Diseases
- Uveitis, Anterior
- Panuveitis
- Uveitis
- Uveal Diseases
- Vasculitis
- Hereditary Autoinflammatory Diseases
- Skin Diseases, Genetic
- Skin Diseases, Vascular
- Behcet Syndrome
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Hydroxychloroquine
Other Study ID Numbers
- 17300279
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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