A Study of Hydroxychloroquine Sulfate in the Treatment of Recurrent Spontaneous Abortion With Antiphospholipid Syndrome

November 5, 2020 updated by: Shanghai First Maternity and Infant Hospital

A Multicenter, Double-blind, Randomized and Parallel Controlled Study of Hydroxychloroquine Sulfate in the Treatment of Recurrent Miscarriage With Antiphospholipid Syndrome

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study uses a multi-center, double-blind, randomized, parallel-controlled research model. In addition to the standard anticoagulant drugs for antiphospholipid syndrome, patients with recurrent miscarriage and APS who meet the enrollment criteria will be randomly divided into hydroxychloroquine sulfate( HCQ) group or placebo group, and randomly assigned according to a 1:1 ratio. Observe the efficacy and safety.

The Hydroxychloroquine sulfate(HCQ) group is the test group. Hydroxychloroquine sulfate 0.2g/d (sig: 0.1g bid po) will be applied 3 months before pregnancy, pregnancy will be started at the 4th month, and aspirin 50mg/d will be added after menstruation( sig: 25mg bid po), low molecular weight heparin 4000-6000 U/d after ovulation or 1 week before embryo transplantation; the placebo group is the control group, and placebo 0.2g/d (sig: 0.1 g bid po) from the fourth month of pregnancy, add aspirin 50mg/d (sig: 25mg bid po) after menstruation, and add low molecular heparin 4000-6000 U/d after ovulation or 1 week before embryo transplantation Both groups were followed up by telephone every 1 month to obtain medication compliance, whether there were adverse reactions, etc., and both oth groups were followed up every 3 months for non-pregnant women by outpatient service , until pregnancy. If the patient is not pregnant within one year, The clinical study of this patient will be terminated, and the patients will be followed up for adverse reactions by telephone one month and three months after withdrawal. If you are pregnant, follow up in the first trimester immediately, and arrange a follow-up every three months thereafter (defined as follow-up in the first trimester, follow-up in the second trimester and follow-up in the third trimester). The drug was discontinued on the day of delivery and the postpartum follow-up was completed 6 weeks after delivery. So, therefore, the entire study time is approximately 27 months.

The researcher mainly records the subjects' vital signs, laboratory indicators, adverse events and combined medications, as well as related indicators of pregnancy check-ups (such as uterine artery blood flow, presence or absence of pregnancy complications, fetal complications, etc.)

Study Type

Interventional

Enrollment (Anticipated)

384

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • shanghai First Maternity and Infant Hospital, Tongji University School of Medicin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Others: such as poor compliance, or those who cannot be followed up on schedule due to certain factors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydroxychloroquine sulfate Tablets
drug:Hydroxychloroquine sulfate Tablets,0.1mg bid po
Drug: Hydroxychloroquine Sulfate Tablets
Hydroxychloroquine Sulfate Tablets ,0.1mg，bid po
Other Names:
  • Fenle
Placebo Comparator: placebo
drug:placebo,0.1mg bid po
Drug: Hydroxychloroquine Sulfate Tablets
Hydroxychloroquine Sulfate Tablets ,0.1mg，bid po
Other Names:
  • Fenle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hydroxychloroquine can improve the pregnancy outcome of patients with recurrent miscarriage and antiphospholipid syndrome
Time Frame: 16 weeks
Hydroxychloroquine is associated with successful pregnancy outcome at 12 weeks of gestation
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hydroxychloroquine can reduce the occurrence of complications during pregnancy
Time Frame: 27 weeks
Reduced incidence of major adverse pregnancy outcomes related to antiphospholipid syndrome
27 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai First Maternity and Infant Hospital

Collaborators

Fudan University
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Zhejiang Provincial People's Hospital
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Zhejiang Provincial Tongde Hospital

Investigators

  • Study Chair: Bao shihua, doctor, shanghai First Maternity and Infant Hospital, Tongji University School of Medicin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

October 31, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShanghaiFMIH-HCQ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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