Sickle Cell Disease Trial, Recruiting NCT04398628 Sponsor: American Thrombosis and Hemostasis Network Condition: Sickle Cell Disease
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Sickle Cell Disease Trial, Recruiting

NCT04398628
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 of any age who have a congenital (present from birth) or acquired (developed over time) blood disorder
  • People who have unusual or excessive bleeding and score above the normal range on a standard bleeding questionnaire (called the ISTH Bleeding Assessment Tool), even if no diagnosis has been found yet
  • People who have a connective tissue disorder (a condition affecting the body's structural tissues) along with a tendency to bleed excessively, as shown by a higher-than-normal score on the bleeding questionnaire
  • People who qualify for one of the currently open disease-specific groups within the trial
  • People who are already enrolled in, or have previously participated in, a related patient registry called the ATHNdataset

Specific groups that may be eligible include:

  • People with hemophilia A or B (including carriers, those with acquired hemophilia, or those who have received gene therapy)
  • People with von Willebrand disease or low von Willebrand factor levels, as defined by current international guidelines
  • People with a congenital (present from birth) platelet disorder affecting how platelets function, clump together, or are structured — including conditions such as Glanzmann thrombasthenia or Bernard-Soulier syndrome (confirm with trial site for full list)
  • People with a confirmed rare clotting or blood disorder such as Factor I, II, V, VII, X, XI, or XIII deficiency; PAI-1 deficiency; plasminogen deficiency; Wiskott-Aldrich syndrome; Thrombotic Thrombocytopenic Purpura; or several other rare conditions (confirm with trial site for full list)
  • People who have unexplained excessive bleeding or a connective tissue disorder with bleeding, scoring above the normal range on the bleeding questionnaire, even without a confirmed diagnosis
  • People who have had a blood clot in a vein or artery, or who have a known condition that makes blood clots more likely (such as Protein C or S deficiency, Factor V Leiden, antiphospholipid syndrome, or similar conditions)
  • People with any other congenital or acquired non-cancerous blood disorder not covered by the other groups listed above

Who may not be able to join:

  • People who do not qualify for any of the currently open disease-specific groups (though they may become eligible if new groups open in the future)
  • People who are unable to give informed consent or, for children, whose parent or guardian is unable to give consent on their behalf
  • People who are unwilling to complete the required study activities
  • People whose platelet disorder is caused by medications or other substances (for the platelet disorders group)
  • People whose tendency to form blood clots is caused by medications (such as birth control pills or hormone replacement therapy), being overweight, smoking, cancer, pregnancy, surgery, injury, long periods of inactivity or bed rest, heart failure, inflammatory bowel disease, or kidney disease (for the clotting/thrombosis group)
  • People with a platelet disorder who also have a diagnosis of von Willebrand disease or hemophilia A or B (for the congenital platelet disorders arm)
  • People enrolled in certain specific arms or modules may face additional exclusions, such as having a previous allergic reaction to a specific medication, having another bleeding disorder at the same time, or currently taking certain other medications — please confirm all details with the trial site

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 27 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: Michael Recht, MD, PhD, MBA, Yale University School of Medicine & National Bleeding Disorders Foundation

Phone: 800-360-2846

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
Sponsor
American Thrombosis and Hemostasis Network
Registry
ClinicalTrials.gov
Start date
30 September 2020
Est. completion
1 June 2035

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To determine the safety of therapies used in the treatment of participants with congenital or acquired non-neoplastic, bleeding and clotting disorders and connective tissue disorders with bleeding tendency (blood disorders).

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: 27 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