Hydroxychloroquine Efficacy on Behcet's Disease Thrombosis

• Sponsor: Assiut University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04022421
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 4.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Behcet's Syndrome, Vascular Type	Drug: Hydroxychloroquine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Efficacy of Hydroxychloroquine on Behcet's Disease Thrombotic Events Prevention
• Actual Study Start Date: Oct 1, 2018
• Anticipated Primary Completion Date: Aug 1, 2019
• Anticipated Study Completion Date: Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: hydroxychloroquine arm	Drug: Hydroxychloroquine; the drug will be taken by one group of the patients daily at a dose of 400mg

Outcome Measures

Primary Outcome Measures

1. Prevention of the recurrence of thrombotic events [6 months- one year]

   number of relapses is expected to fall with the longterm use of the drug

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University Hospital	Assiut		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alaa Abdelkhalik Ahmed Mohamed, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04022421
• Other Study ID Numbers: 17300279
• First Posted: Jul 17, 2019
• Last Update Posted: Jul 25, 2019
• Last Verified: Jul 1, 2019

• 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
• Additional relevant MeSH terms: Behcet Syndrome; Hydroxychloroquine

Study Results

No Results Posted as of Jul 25, 2019