Antiphospholipid SyndromePhase 3NCT01784523
Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients
A Phase 3 study testing Hydroxychloroquine in people with Antiphospholipid Syndrome, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
In this multi-center international study, our aim is to determine the effectiveness of HCQ for primary thrombosis prophylaxis in persistently aPL-positive but thrombosis-free patients without systemic autoimmune diseases. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Antiphospholipid Syndrome
- What is being tested?
- Hydroxychloroquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to 30 Sep 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Persistent(at least 12 weeks apart)aPL-positivity within 12 months prior to the screening defined as:
- aCL IgG/M (>40U,medium-to-high titer,and/or greater than the 99th percentile)and/or
- aβ2GPI IgG/M(>40U, medium-to-high titer, and/or greater than the 99th percentile)and/or
- Positive LA test based on the International Society of Thrombosis \& Haematosis Recommendations
- Selected Exclusion Criteria:
- History of thrombosis (arterial, venous, and/or biopsy proven microthrombosis
Show all 16Show fewer
- History of Transient Ischemic Attack Confirmed by a Neurologist
- SLE Diagnosis based on the ACR Classification Criteria > 4/11
- Other Systemic Autoimmune Diseases diagnosed based on ACR Classification Criteria
- Current Hydroxychloroquine or another antimalarial treatment (-3 months)
- Current warfarin treatment (-3 months)
- Current heparin therapy( -3 months)
- Current pregnancy
- History of Hydroxychloroquine eye toxicity
- History of Hydroxychloroquine allergy
- Known glucose-6-phosphate dehydrogenase deficiency
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: A Prospective Randomized Controlled Trial of Hydroxychloroquine in the Primary Thrombosis Prophylaxis of aPL Positive But Thrombosis-free Patients.
In this multi-center international study, our aim is to determine the effectiveness of HCQ for primary thrombosis prophylaxis in persistently aPL-positive but thrombosis-free patients without systemic autoimmune diseases.
Read the detailed description
Randomized to receive HCQ or no treatment in addition to their standard regimen. 11 study visits and 10 phone visits over 5 years.
This study was terminated at 2 years due to low recruitment rate exacerbated by manufacturing shortage and price increase of hydroxychloroquine.
- Conditions
- Antiphospholipid Syndrome
- Being tested
- Hydroxychloroquine
- Keywords
- antiphospholipid autoantibodies, antiphospholipid positive
- Medical subject headings
- Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called plaquenil
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | No intervention | patients randomized to standard treatment will not receive hydroxychloroquine. |
| Hydroxychloroquine | Experimental | Patients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing <60kg; and 400 mg daily (200 mg twice a day)for patients weighing >60kg. Receives: Drug: Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Acute Thrombosis Event
To determine the efficacy of Hydroxychloroquine in the primary thrombosis prevention of persistently aPL-positive but thrombosis free patients with no other systemic autoimmune diseases over the five year study period.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completion30 Sep 2015
- Study completion30 Sep 2015
Why it stopped: low recruitment rate exacerbated by manufacturing shortage and price increase of hydroxychloroquine.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Antiphospholipid SyndromeStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking, The New York Community Trust
- Responsible party
- Sponsor
- Investigators
- Doruk Erkan, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784523
- Sponsor's protocol ID
- 2014-253
- Status last verified
- Aug 2021
- First submitted
- 3 Feb 2013
- Last updated
- 14 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Erkan D, Lockshin MD; APS ACTION members. APS ACTION--AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking. Lupus. 2012 Jun;21(7):695-8. doi: 10.1177/0961203312437810.
PubMed 22635205Erkan D, Derksen R, Levy R, Machin S, Ortel T, Pierangeli S, Roubey R, Lockshin M. Antiphospholipid Syndrome Clinical Research Task Force report. Lupus. 2011 Feb;20(2):219-24. doi: 10.1177/0961203310395053.
PubMed 21303838
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Hydroxychloroquine in the Primary Thrombosis Prophylaxis of aPL Positive But Thrombosis-free Patients.
- ClinicalTrials.gov ID
- NCT01784523
- Acronym / sponsor ID
- 2014-253
- Conditions
- Antiphospholipid Syndrome
- Keywords
- antiphospholipid autoantibodies, antiphospholipid positive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment rate exacerbated by manufacturing shortage and price increase of hydroxychloroquine.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking, The New York Community Trust
- Study start
- Feb 2013
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 30 Sep 2015 (actual)
- First posted
- 6 Feb 2013 (estimated)
- Results
- Posted 4 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this multi-center international study, our aim is to determine the effectiveness of HCQ for primary thrombosis prophylaxis in persistently aPL-positive but thrombosis-free patients without systemic autoimmune diseases.
Detailed description
Randomized to receive HCQ or no treatment in addition to their standard regimen. 11 study visits and 10 phone visits over 5 years.
This study was terminated at 2 years due to low recruitment rate exacerbated by manufacturing shortage and price increase of hydroxychloroquine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | No intervention | –patients randomized to standard treatment will not receive hydroxychloroquine. |
| Hydroxychloroquine | Experimental | Drug: HydroxychloroquinePatients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing <60kg; and 400 mg daily (200 mg twice a day)for patients weighing >60kg. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Persistent(at least 12 weeks apart)aPL-positivity within 12 months prior to the screening defined as:
- History of thrombosis (arterial, venous, and/or biopsy proven microthrombosis
- History of Transient Ischemic Attack Confirmed by a Neurologist
- SLE Diagnosis based on the ACR Classification Criteria > 4/11
- Other Systemic Autoimmune Diseases diagnosed based on ACR Classification Criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| HydroxychloroquineAlso: plaquenil | Drug | Hydroxychloroquine |
Primary outcome
Number of Participants With an Acute Thrombosis Event
Time frame: 2 years
To determine the efficacy of Hydroxychloroquine in the primary thrombosis prevention of persistently aPL-positive but thrombosis free patients with no other systemic autoimmune diseases over the five year study period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22635205Erkan D, Lockshin MD; APS ACTION members. APS ACTION--AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking. Lupus. 2012 Jun;21(7):695-8. doi: 10.1177/0961203312437810.
- Background: PubMed 21303838Erkan D, Derksen R, Levy R, Machin S, Ortel T, Pierangeli S, Roubey R, Lockshin M. Antiphospholipid Syndrome Clinical Research Task Force report. Lupus. 2011 Feb;20(2):219-24. doi: 10.1177/0961203310395053.
- APS ACTIONLink provided by the sponsor.
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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.
Doruk Erkan, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine in people with Antiphospholipid Syndrome, run by Hospital for Special Surgery, New York at 1 site in United States.
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 16 inclusion and 0 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: stopped early, as of the sponsor's last update on 14 Sep 2021. 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 United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With an Acute Thrombosis Event (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01784523, which also lists 2 linked publications.
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 14 Sep 2021.