Hydroxychloroquine Efficacy on Behcet's Disease Thrombosis | NCT04022421

Studies
Hydroxychloroquine Efficacy on Behcet's Disease Thrombosis

NCT04022421

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jul 25, 2019Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Behcet's Syndrome, Vascular Type

Interventions

Hydroxychloroquine

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Aug 2019Estimated

Completion Date

Oct 2019Estimated

First Submitted Date

Jul 15, 2019

First Submission Date that Met QC Criteria

Jul 15, 2019

First Posted Date

Jul 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2019

Last Update Posted Date

Jul 25, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alaa Abdelkhalik Ahmed Mohamed, Principal Investigator, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hydroxychloroquine arm	Experimental		Drug: Hydroxychloroquine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hydroxychloroquine	Drug	the drug will be taken by one group of the patients daily at a dose of 400mg	hydroxychloroquine arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevention of the recurrence of thrombotic events	number of relapses is expected to fall with the longterm use of the drug	6 months- one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alaa Mohamed, Post-doctor	Contact	+20882413177		a.a.a.mohamed@aun.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University Hospital	Recruiting	Asyut			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D001528	Behcet Syndrome

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D014606	Uveitis, Anterior
D015864	Panuveitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006886	Hydroxychloroquine

Ancestor Terms

ID	Term
D002738	Chloroquine
D000634	Aminoquinolines
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring

Browse Leaves

Not provided

Browse Branches

Not provided