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This trial is complete. It is no longer accepting participants.

NCT00016458

NCT00016458
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with diffuse systemic sclerosis (a serious form of scleroderma that affects the whole body)
  • Your disease is getting worse, with a skin score of at least 16 (a measure of skin thickening)
  • You have lung or kidney involvement meeting certain specific measurements (confirm with trial site)
  • Your lung function has dropped significantly (at least 15%) in the past 6 months, OR there is new evidence of lung inflammation on scans or fluid testing (confirm with trial site)
  • Your lungs are still functioning above a minimum level (a specific breathing test result above 20% of the expected value)
  • You are either not eligible for, or have chosen not to have, a stem cell or bone marrow transplant
  • You are able to carry out at least some daily activities (functioning at 50% or more on a standard medical scale)
  • Your blood cell counts are at an acceptable level (confirm specific values with trial site)
  • Your liver function tests are within an acceptable range
  • Your kidneys are working well enough (filtering at least 35 mL per minute) and you do not need dialysis
  • Your heart is pumping effectively (above 45%) and is generally stable
  • You are not pregnant, and if you could become pregnant, you are willing to use reliable contraception
  • You have tested negative for HIV

Who may not be able to join:

  • You are experiencing acute kidney failure caused by a systemic sclerosis crisis
  • You have had a heart attack in the last 12 months
  • You have unstable chest pain (angina)
  • You have uncontrolled heart rhythm problems
  • You have signs of heart failure
  • You are currently on dialysis for kidney problems
  • You are pregnant or are not willing to use contraception (if able to have children)
  • You currently have an active infection that is not under control
  • You have a known allergy or sensitivity to rabbit proteins
  • You have had severe bladder bleeding in the past that required a blood transfusion
  • You currently have active bladder bleeding (if you have a history of this)
  • You currently have or are being treated for any cancer
  • You have not waited at least 4 days since your last immune-suppressing medication (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.

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
Fred Hutchinson Cancer Center
Registry
clinicaltrials_gov
Start date
1 June 2000

Where this trial is recruiting

🇺🇸 United States

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