NCT04624269

Brief Summary

The efficacy of low-dose aspirin combined with low-molecular-weight heparin treatment for improving antiphospholipid syndrome and maternal-fetal outcome of patients is recognized by various countries and recommended by the guidelines. However, there are still 20-30% of APS patients whose treatment fails. Therefore, the standard treatment effect is still not ideal, and other treatment options need to be explored. The purpose of this study is to conduct a randomized double-blind, parallel controlled study of patients with recurrent miscarriage and APS in addition to standard treatment, plus hydroxychloroquine sulfate (HCQ) or placebo, to observe the effects of HCQ on pregnancy outcome in patients with abortion and APS, to evaluate the effectiveness and safety of HCQ treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
384

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

October 31, 2020

Last Update Submit

November 5, 2020

Conditions

Antiphospholipid SyndromeRecurrent Miscarriage

Keywords

Antiphospholipid syndromehydroxychloroquineRecurrent Miscarriage

Outcome Measures

Primary Outcomes (1)

  • Hydroxychloroquine can improve the pregnancy outcome of patients with recurrent miscarriage and antiphospholipid syndrome

    Hydroxychloroquine is associated with successful pregnancy outcome at 12 weeks of gestation

    16 weeks

Secondary Outcomes (1)

  • Hydroxychloroquine can reduce the occurrence of complications during pregnancy

    27 weeks

Study Arms (2)

Hydroxychloroquine sulfate Tablets

EXPERIMENTAL

drug:Hydroxychloroquine sulfate Tablets,0.1mg bid po

Drug: Hydroxychloroquine Sulfate Tablets

placebo

PLACEBO COMPARATOR

drug:placebo,0.1mg bid po

Drug: Hydroxychloroquine Sulfate Tablets

Interventions

Hydroxychloroquine Sulfate TabletsDRUG

Hydroxychloroquine Sulfate Tablets ,0.1mg，bid po

Also known as: Fenle
Hydroxychloroquine sulfate Tabletsplacebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who want to conceive，with recurrent miscarriage and antiphospholipid syndrome (APS) .
  • Agree to join the study and sign the informed consent of the study.

You may not qualify if:

  • Women who are already pregnant.
  • Allergies or adverse events to Hydroxychloroquine(HCQ),such as allergies to the active substance -aminoquinoline or allergies to HCQ or any other chemical components of placebo.
  • Patients with any changes in the retina or visual field caused by treatment with 4-aminoquinoline compounds;
  • HCQ is currently being used
  • Weight \<45kg
  • Psoriasis
  • Uncontrolled epilepsy
  • Anti-ENA antibody positive
  • Renal replacement therapy
  • Other serious active complications (human immunodeficiency virus, hepatitis B)
  • Porphyria
  • History of retinopathy
  • History of galactose intolerance, history of lactase deficiency, or history of glucose-galactose malabsorption
  • Participate in any other clinical trial drug research at the same time.
  • Previous treatment failure with Hydroxychloroquin
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

shanghai First Maternity and Infant Hospital, Tongji University School of Medicin

Shanghai, China

Location

Related Publications (6)

  • Mak A, Cheung MW, Cheak AA, Ho RC. Combination of heparin and aspirin is superior to aspirin alone in enhancing live births in patients with recurrent pregnancy loss and positive anti-phospholipid antibodies: a meta-analysis of randomized controlled trials and meta-regression. Rheumatology (Oxford). 2010 Feb;49(2):281-8. doi: 10.1093/rheumatology/kep373. Epub 2009 Dec 4.

    PMID: 19965971BACKGROUND

  • Sciascia S, Branch DW, Levy RA, Middeldorp S, Pavord S, Roccatello D, Ruiz-Irastorza G, Tincani A, Khamashta M, Schreiber K, Hunt BJ. The efficacy of hydroxychloroquine in altering pregnancy outcome in women with antiphospholipid antibodies. Evidence and clinical judgment. Thromb Haemost. 2016 Jan;115(2):285-90. doi: 10.1160/TH15-06-0491. Epub 2015 Sep 17.

    PMID: 26421409RESULT

  • Abarientos C, Sperber K, Shapiro DL, Aronow WS, Chao CP, Ash JY. Hydroxychloroquine in systemic lupus erythematosus and rheumatoid arthritis and its safety in pregnancy. Expert Opin Drug Saf. 2011 Sep;10(5):705-14. doi: 10.1517/14740338.2011.566555. Epub 2011 Mar 22.

    PMID: 21417950RESULT

  • Mekinian A, Lazzaroni MG, Kuzenko A, Alijotas-Reig J, Ruffatti A, Levy P, Canti V, Bremme K, Bezanahary H, Bertero T, Dhote R, Maurier F, Andreoli L, Benbara A, Tigazin A, Carbillon L, Nicaise-Roland P, Tincani A, Fain O; SNFMI and the European Forum on Antiphospholipid Antibodies. The efficacy of hydroxychloroquine for obstetrical outcome in anti-phospholipid syndrome: Data from a European multicenter retrospective study. Autoimmun Rev. 2015 Jun;14(6):498-502. doi: 10.1016/j.autrev.2015.01.012. Epub 2015 Jan 21.

    PMID: 25617818RESULT

  • Branch DW, Peaceman AM, Druzin M, Silver RK, El-Sayed Y, Silver RM, Esplin MS, Spinnato J, Harger J. A multicenter, placebo-controlled pilot study of intravenous immune globulin treatment of antiphospholipid syndrome during pregnancy. The Pregnancy Loss Study Group. Am J Obstet Gynecol. 2000 Jan;182(1 Pt 1):122-7. doi: 10.1016/s0002-9378(00)70500-x.

    PMID: 10649166RESULT

  • Sciascia S, Hunt BJ, Talavera-Garcia E, Lliso G, Khamashta MA, Cuadrado MJ. The impact of hydroxychloroquine treatment on pregnancy outcome in women with antiphospholipid antibodies. Am J Obstet Gynecol. 2016 Feb;214(2):273.e1-273.e8. doi: 10.1016/j.ajog.2015.09.078. Epub 2015 Sep 30.

    PMID: 26429521RESULT

MeSH Terms

Conditions

Antiphospholipid SyndromeAbortion, Habitual

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System DiseasesAbortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bao shihua, doctor

    shanghai First Maternity and Infant Hospital, Tongji University School of Medicin

    STUDY CHAIR

Central Study Contacts

Du mengyang, Master

CONTACT

0086-13636467524dumengyanga@51mch.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2020

First Posted

November 10, 2020

Study Start

December 1, 2020

Primary Completion

November 1, 2021

Study Completion

February 1, 2023

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)