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

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai First Maternity and Infant Hospital
• Collaborators: Fudan University; Shanghai Jiao Tong University Affiliated Sixth People's Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Zhejiang Provincial People's Hospital; Zhejiang Provincial Tongde Hospital
• Treatments: Hydroxychloroquine

Criteria

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.