- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03305263
Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss
Hydroxycloroquin (Plaquenil) Behandling af Gentagne Graviditetstab (Abortus Habitualis) - et Randomiseret, Dobbeltblindet, Placebo Kontrolleret Studium
Recurrent pregnancy loss (RPL) defined as 3 or more pregnancy losses affects approximately 3% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the chance of a live birth. Exciting indications for using Hydroxychloroquine (HCQ) include: Malaria profylaxis and treatment, systemic and discoid lupus erythematosus (SLE) and rheumatoid athritis (RA). HCQ has been reported to have the following properties (anti-thrombotic, vascular-protective, immunomodulatory, improving glucose tolerance, lipid-lowering, and anti-infectious).
There is no data concerning the benefit of HCQ in RPL. Administration for other indications provides extensive safety data during pregnancy.
This study has the potential to establish support for a new treatment option for unexplained RPL.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Henriette Svarre Nielsen, MD, DMSc
- Phone Number: +4535457515
- Email: henriette.svarre.nielsen@regionh.dk
Study Contact Backup
- Name: Louise Lunøe, Nurse
- Phone Number: +4535458486
- Email: anne.louise.lunoee@regionh.dk
Study Locations
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København, Denmark, 2100
- Recruiting
- Rigshospitalet
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Contact:
- Louise Lunøe, Nurse
- Phone Number: +4535458486
- Email: anne.louise.lunoee@regionh.dk
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Contact:
- Henriette S Nielsen, MD
- Phone Number: +4535457515
- Email: henriette.svarre.nielsen@regionh.dk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ≥ 4 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL
- ≥ 3 confirmed consecutive pregnancy losses prior to gestational age 22+0 in women with unexplained RPL with minimum one second trimester loss.
Exclusion Criteria:
- Age below 18 years or above 39 at inclusion
- Abnomal uterine anatomi at hysterosalpingography/hysteroscopy or hydrosonography
- Chromosomal abnormalities within the couple
- Menstrual cycle below 23 days or above 35 days
- Lupusantikoagulans positivity or immunoglobulin (Ig)G/IgM anticardiolipinantibodies (≥10 GPL kU/l at Rigshospitalets Laboratorium) or plasma homocystein ≥25 mikrogr./l at repeated measurement with 12 weeks interval.
- HIV or Hepatitis B or C positive
- Psoriasis, retinopathy og serious imparied hearing (Contraindications for HCQ)
- Chronic disease that lead to intake of immunemodulatory drugs or potentially pregnancy toxic agents
- Hemoglobin ≤ 6.5 mmol/L, leukocytes <3.5 E9/L, platelets <145 E9/L at inclusion
- Previous treatment with HCQ in pregnancy
- >1previous live birth
- previous participation in this trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hydroxychlorochine HCQ
Women in the experimental arm will take 200 mg HCQ tablets every day, starting minimum 2 months (recommended 3-6) prior to conception and continuing until 28 weeks of pregnancy or until the pregnancy is over.
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One tablet a day from inclusion until end of pregnancy or gestational age 28
Other Names:
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Placebo Comparator: Hydroxychlorochine HCQ Placebo
Women in the experimental arm will take 200 mg HCQ placebo tablets every day, starting minimum 2 months (recommended 3-6) prior to conception and continuing until 28 weeks of pregnancy or until the pregnancy is over.
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One tablet a day from inclusion until end of pregnancy or gestational age 28
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Live birth
Time Frame: At delivery
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At delivery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Live birth after exclusion of patients with a chromosomal abnormal pregnancy loss, extrauterine pregnancy loss, intended abortion or patients with insufficient intake of study medicine
Time Frame: At delivery
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At delivery
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Birth weight
Time Frame: At delivery
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At delivery
|
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Gestational age
Time Frame: up to at delivery
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up to at delivery
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Admittance to neonatal unit
Time Frame: Within 28 days of delivery
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Within 28 days of delivery
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Immunological status
Time Frame: Up to two years after end of study
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Measuements of celllur and humoral immunity
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Up to two years after end of study
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCQDenmark
- 2016-004981-24 (Other Grant/Funding Number: Regionernes Medicinpulje 15/1719)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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-
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Caroline Nørgaard-PedersenDepartment of Clinical Immunology, Odense University Hospital, DK; Department...RecruitingRecurrent Pregnancy Loss, Not PregnantDenmark
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Peking University Third HospitalCompletedRecurrent Early Pregnancy LossChina
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