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NCT04624269
A Study of Hydroxychloroquine Sulfate in the Treatment of Recurrent Spontaneous Abortion With Antiphospholipid Syndrome
Phase 4 trial testing Hydroxychloroquine Sulfate Tablets in Antiphospholipid Syndrome in 384 participants. Status unknown.
1 November 2021
Quick facts
| Lead sponsor | Shanghai First Maternity and Infant Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 384 |
| Start date | 1 December 2020 |
| Primary completion | 1 November 2021 |
| Estimated completion | 1 February 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Hydroxychloroquine Sulfate Tablets — full drug profile →
Conditions studied
- Antiphospholipid Syndrome — all drugs for Antiphospholipid Syndrome →
- Recurrent Miscarriage — all drugs for Recurrent Miscarriage →
Sponsor
Shanghai First Maternity and Infant Hospital
Who can join
Adults 18 to 45, female only, with Antiphospholipid Syndrome or Recurrent Miscarriage. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04624269
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Antiphospholipid Syndrome
Currently open trials in the same condition.
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- NCT07163338 — Prevalence and Consequences of Antiphospholipid Syndrome in Patients Aged 65 and Over With Ischemic Strokes (IS) · NA · recruiting
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Other Shanghai First Maternity and Infant Hospital trials
Trials by the same sponsor.
- NCT07426146 — Feasibility Effects of a Low-GI, High-fibre Diet in PCOS: a Prospective Cohort Study in Remote Yunnan · recruiting
- NCT06093984 — Cumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders · NA · not yet recruiting
- NCT06049186 — CRD vs. Met in Patients With Obese PCOS Infertility · NA · unknown
- NCT06096805 — Prediction of Placental Fetal Growth Restriction in High Risk Population (PoPFGR) · recruiting
- NCT06104748 — A Cohort of Maternal Vascular Malperfusion-related FGR (CoMVMFGR) · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04624269 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai First Maternity and Infant Hospital
- Last refreshed: 10 November 2020
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