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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT00004412

NCT00004412
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with a significant sickle cell condition, including Hemoglobin SS, Hemoglobin S-beta thalassemia, or a related hemoglobin variant
  • You are between 16 and 60 years old
  • You have one or more ulcers on your lower leg or ankle that have not healed for at least 6 months
  • Your liver is functioning normally, with liver enzyme levels at or below 250 IU
  • Your kidneys are functioning normally, with creatinine levels at or below 1.2 mg/mL (for adults) or 0.9 mg/mL (for teenagers)
  • If you have a skin infection (cellulitis) or other infection around the ulcer, you must have received antibiotic treatment for it before joining the trial

Who may not be able to join:

  • You are pregnant
  • You are able to have children but are not using effective birth control
  • You have liver problems or abnormal liver enzyme levels above 250 IU
  • You have kidney problems or creatinine levels above 1.2 mg/mL (adults) or 0.9 mg/mL (teenagers)
  • You are currently receiving regular blood transfusions as an ongoing treatment
  • You have had or are currently receiving chemotherapy for cancer
  • You are currently taking a type of medication called butyrate derivatives (confirm with trial site)
  • You are currently taking steroid medications (corticosteroids)
  • You have seizures that are not well controlled by treatment
  • You have another condition that may weaken your immune system

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.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Susan P. Perrine
Registry
clinicaltrials_gov
Start date
1 September 1997
Est. completion
1 December 2002

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Healing Defined as a Decrease in Ulcer Area by at Least 25% of the Initial Area

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov