Phase 4 Sickle Cell Disease Trial, Recruiting NCT06665997 Sponsor: University of Pennsylvania Condition: Sickle Cell Disease
Back to Sickle Cell Disease

Phase 4 Sickle Cell Disease Trial, Recruiting

NCT06665997
Recruiting Phase 4

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:

  • You are willing and able to sign and date a consent form agreeing to take part
  • You are female and between 18 and 50 years old
  • You have been diagnosed with sickle cell disease (one of these types: SS, SBeta0, SBeta+, or SC)
  • You have had at least 1 pain crisis per month on average over the past 6 months
  • You have had between 1 and 10 hospital visits, emergency room visits, or outpatient infusion visits for pain crises in the past year (unless the lead study doctor approves an exception)
  • You are willing to stop using any hormonal contraception when you join, and have stopped using it for at least 1 month before joining (or 4 months if you used the injectable contraceptive depot medroxyprogesterone)
  • You have regular menstrual cycles (when not using hormonal contraception) that usually last between 21 and 35 days
  • You have been on a stable dose of hydroxyurea and any other sickle cell medications for the past 6 months
  • You have a phone or device that can send and receive text messages
  • You are able to read and understand English
  • You are willing to follow all study procedures

Who may not be able to join:

  • You have a long-term inflammatory condition such as lupus or inflammatory bowel disease
  • You have a history of blood clots in the veins (VTE) or stroke
  • You are currently using crizanlizumab, voxelotor, or receiving regular blood transfusions, or you have had a stem cell transplant in the past
  • You are currently using any hormonal contraception or have a copper intrauterine device (copper IUD)
  • You are currently pregnant or have been pregnant in the last 6 months
  • You are currently breastfeeding
  • You have polycystic ovary syndrome (PCOS) or have irregular periods
  • Your blood pressure was 160/100 or higher at the screening visit
  • The study doctor believes that taking part in the trial could put you at risk, affect the study results, or prevent you from completing the full study (confirm with 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 26 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Andrea Roe, MD MPH, University of Pennsylvania

Phone: 267-785-8044

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
Phase 4
Registry
ClinicalTrials.gov
Start date
26 June 2025
Est. completion
31 July 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Frequency of acute vaso-occlusive episodes

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: 26 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