Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients

NCT01784523 | Terminated Phase 3 Results DMC

• 1 other identifier: 2014-253
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Antiphospholipid Syndrome

Keywords

antiphospholipid autoantibodies; antiphospholipid positive

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Study Arms (2)

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.

Drug: Hydroxychloroquine

Interventions

Hydroxychloroquine DRUG

Also known as: plaquenil

Hydroxychloroquine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking: collaborator
• The New York Community Trust: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (2)

• 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.

  PMID: 22635205 BACKGROUND

• Erkan 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.

  PMID: 21303838 BACKGROUND

Related Links

• APS ACTION

MeSH Terms

Conditions

Antiphospholipid Syndrome

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Doruk Erkan, MD
• Organization: Hospital for Special Surgery

erkand@hss.edu

212 774-2291

Study Officials

• Doruk Erkan, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2013
• First Posted: February 6, 2013
• Study Start: February 1, 2013
• Primary Completion: September 30, 2015
• Study Completion: September 30, 2015
• Last Updated: September 14, 2021
• Results First Posted: May 4, 2021

Record last verified: 2021-08

Locations

US (1)