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Hydroxychloroquine Efficacy on Behcet's Disease Thrombosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04022421
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Alaa Abdelkhalik Ahmed Mohamed, Assiut University

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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 : October 1, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019


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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04022421


Contacts
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Contact: Alaa Mohamed, Post-doctor +20882413177 a.a.a.mohamed@aun.edu.eg

Locations
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Egypt
Assiut University Hospital Recruiting
Assiut, Egypt
Contact: Alaa Mohamed    +201018554227    a.a.a.mohamed@aun.edu.eg   
Sponsors and Collaborators
Assiut University

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Responsible Party: Alaa Abdelkhalik Ahmed Mohamed, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04022421     History of Changes
Other Study ID Numbers: 17300279
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

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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:
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Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveitis, Anterior
Panuveitis
Uveitis
Uveal Diseases
Eye Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents