Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruitingRare disease

Study on Hydroxychloroquine for Improving Pregnancy Outcomes in Women with Antiphospholipid Antibodies

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called hydroxychloroquine sulfate on pregnancy outcomes in women who have antiphospholipid antibodies. These antibodies are proteins in the blood that can increase the risk of blood clots and pregnancy complications. The trial aims to see if taking hydroxychloroquine sulfate can improve pregnancy outcomes for these women.

Participants in the study will be randomly assigned to receive either hydroxychloroquine sulfate or a placebo, which is a tablet that looks like the medication but does not contain any active ingredients. The study will monitor the participants throughout their pregnancy to observe any effects on pregnancy loss, premature birth, and other related outcomes. The medication will be taken orally in the form of film-coated tablets.

The trial will also assess the safety and tolerability of hydroxychloroquine sulfate for both the mother and the newborn. The study is expected to continue until the end of 2027, with participants being followed closely to gather comprehensive data on the effects of the treatment. The ultimate goal is to determine whether hydroxychloroquine sulfate can be a beneficial treatment option for improving pregnancy outcomes in women with antiphospholipid antibodies.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the details and potential risks of the study.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying the presence of antiphospholipid antibodies through a positive test for anticardiolipin antibodies, lupus anticoagulant, or anti-beta 2 glycoprotein-I on two or more occasions, more than 12 weeks apart.

  3. Step 3

    Medication administration

    You will be randomly assigned to receive either hydroxychloroquine sulfate 200 mg film-coated tablets or a placebo. The placebo is a white, circular tablet marked with '200' on one side.

    The medication is taken orally. The dosage and frequency will be specified by the study team, and you will be required to follow these instructions throughout the trial.

  4. Step 4

    Regular monitoring

    Regular monitoring will be conducted to assess your health and the pregnancy outcome. This includes routine check-ups and tests as determined by the study protocol.

  5. Step 5

    Completion of the trial

    The trial is expected to continue until December 31, 2027. Upon completion, your participation in the study will end, and you will receive information about the results and any further steps if necessary.

Who can join the trial?

4 criteria

  • Must be a woman who is planning to become pregnant.
  • Must have a known condition called antiphospholipid antibodies (aPL) or APS. This means having certain antibodies in the blood that are tested positive on two or more occasions, at least 12 weeks apart.
  • The last positive test for these antibodies must be within 12 months before joining the study.
  • Must provide written informed consent to participate, which means agreeing to join the study after understanding all the details.

Who cannot join the trial?

5 criteria

  • Patients who do not have antiphospholipid antibodies cannot participate. These are specific proteins in the blood that can affect blood clotting.
  • Only women are eligible to participate in this study.
  • Men are not allowed to participate in this study.
  • Participants must be within a specific age range, which is not specified here.
  • Individuals considered part of a vulnerable population are not eligible. This typically includes groups like children, pregnant women, or those unable to give consent, but specifics are not provided here.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruitingNot recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Hydroxychloroquine is a medication that is being studied to see if it can help improve pregnancy outcomes in women who have antiphospholipid antibodies. These antibodies can sometimes cause complications during pregnancy, and researchers want to find out if taking hydroxychloroquine can make a positive difference. This medication is often used to treat other conditions like malaria and certain autoimmune diseases, and it works by affecting the immune system. In this trial, the focus is on understanding how it might help pregnant women with specific antibodies have healthier pregnancies.

What is already known about the treatment

Hydroxychloroquine – Hydroxychloroquine is typically administered orally in the form of tablets. It is currently being studied in clinical trials to assess its effectiveness in improving pregnancy outcomes for women with antiphospholipid antibodies, a condition that can lead to complications during pregnancy. The medication is primarily used to treat autoimmune diseases by modulating the immune system. At the molecular level, hydroxychloroquine works by interfering with the communication between cells in the immune system, which helps reduce inflammation. It is classified as an antimalarial and immunomodulatory drug.

Investigated diseases

Antiphospholipid Syndrome – Antiphospholipid Syndrome is an autoimmune disorder characterized by the presence of antiphospholipid antibodies in the blood. These antibodies increase the risk of blood clots forming in veins and arteries, which can lead to complications such as deep vein thrombosis or stroke. In pregnant women, the condition can cause pregnancy-related complications, including recurrent miscarriages, stillbirths, and preterm delivery. The syndrome can also lead to other issues like low platelet counts and heart valve problems. The progression of the disease varies, with some individuals experiencing frequent complications, while others may have long periods without symptoms. The presence of antiphospholipid antibodies is a key factor in the disease's progression and impact on health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504661-23-00Estimated enrolment300 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.