Sickle Cell Disease Trial, Recruiting NCT03976180 Sponsor: Assistance Publique - Hôpitaux de Paris Condition: Sickle Cell Disease
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Sickle Cell Disease Trial, Recruiting

NCT03976180
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 years or older
  • People who have been diagnosed with a major form of sickle cell disease (specifically the SS, SC, Sβ0, or Sβ+ types)
  • People who are currently experiencing a pain crisis — meaning acute pain or tenderness in at least one area of the body (such as the arms, legs, ribs, breastbone, skull, spine, or pelvis) that requires opioid pain medication and has no other explanation
  • People whose blood test results place them at intermediate-to-high risk of developing a lung complication called acute chest syndrome, based on a scoring system called the PRESEV score — this involves specific levels of certain blood counts (confirm with trial site for exact values)
  • People who have given their informed consent to participate
  • People who are enrolled in the French social security system

Who may not be able to join:

  • People who already have acute chest syndrome at the time of joining — meaning they already have chest pain or unusual breathing sounds along with a new shadow on a chest X-ray, scan, or lung ultrasound
  • People whose pain crisis has required intravenous or injected opioid pain relief for more than 72 hours before joining the trial
  • People who are known to be pregnant or currently breastfeeding; women who could potentially be pregnant will be tested before joining
  • People with a known condition affecting the blood vessels in the brain, or who have previously had a stroke linked to narrowed or blocked brain vessels
  • People with known heart disease caused by reduced blood flow, or who experience chest pain related to the heart
  • People who are currently taking part in another clinical drug trial
  • People who are legally unable to give consent for themselves
  • People who are prisoners or are being held involuntarily
  • People whose anatomy makes it impossible to wear a nasal cannula (the small tube placed under the nose to deliver oxygen or other gases)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Armand Mekontso, Assistance Publique - Hôpitaux de Paris

Phone: +33 (1) 49 81 23 94

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
27 April 2020
Est. completion
27 November 2025

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Rate of cardiac and neurologic related events (Pilot Stage); Rate of vaso-occlusive pain crisis (VOC) resolution without complication (Activity stage); Rate of secondary acute chest syndrome (ACS)(Efficacy Stage)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov