Behcet's Syndrome, Vascular TypeNCT04022421
Hydroxychloroquine Efficacy on Behcet's Disease Thrombosis
A study testing Hydroxychloroquine in people with Behcet's Syndrome, Vascular Type, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behcet's Syndrome, Vascular Type
- What is being tested?
- Hydroxychloroquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients diagnosed with Behcet's disease on any DMARDs
Who cannot join
- Patients with critical conditions
- Patients with hypersensitivity or adverse drug reactions to hydroxychloroquine.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut
Alaa Mohamed, +201018554227, a.a.a.mohamed@aun.edu.eg
About this study
Official title: 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.
- Conditions
- Behcet's Syndrome, Vascular Type
- Being tested
- Hydroxychloroquine
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the drug will be taken by one group of the patients daily at a dose of 400mg
| Study group | Role | What they receive |
|---|---|---|
| hydroxychloroquine arm | Experimental | Not described Receives: Drug: Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of the recurrence of thrombotic events
number of relapses is expected to fall with the longterm use of the drug
Measured: 6 months- one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 Oct 2018
- Primary completionAug 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet's Syndrome, Vascular TypeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Abdelkhalik Ahmed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022421
- Sponsor's protocol ID
- 17300279
- Status last verified
- Jul 2019
- First submitted
- 15 Jul 2019
- Last updated
- 25 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Hydroxychloroquine on Behcet's Disease Thrombotic Events Prevention
- ClinicalTrials.gov ID
- NCT04022421
- Acronym / sponsor ID
- 17300279
- Conditions
- Behcet's Syndrome, Vascular Type
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hydroxychloroquine arm | Experimental | Drug: Hydroxychloroquine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients diagnosed with Behcet's disease on any DMARDs
Key exclusion criteria (2 listed)
- Patients with critical conditions
- Patients with hypersensitivity or adverse drug reactions to hydroxychloroquine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquinethe drug will be taken by one group of the patients daily at a dose of 400mg | Drug | hydroxychloroquine arm |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxychloroquine in people with Behcet's Syndrome, Vascular Type, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa Mohamed, Post-doctor (+20882413177, a.a.a.mohamed@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of the recurrence of thrombotic events (time frame: 6 months- one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019.