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

NCT00004441

NCT00004441
Completed Not Applicable

Who may be able to join

Who might be able to join this trial:

  • You have cystic fibrosis and liver disease, shown by at least one of the following: liver enzyme levels that were significantly higher than normal at least once in the past year; a noticeably enlarged liver lasting more than 6 months; an enlarged spleen that can be felt during a physical exam; or abnormal liver findings on an ultrasound scan within the past 6 months
  • If you took part in the first part of this study, you may also be eligible to join the second part
  • It has been at least 3 months since you last took a medication called ursodiol
  • It has been at least 3 months since you last took any medication that affects bile production or bile acid metabolism (confirm with trial site)
  • You weigh at least 15 kg (about 33 pounds)
  • Your overall health and nutrition are not severely affected

Who may not be able to join:

  • You have advanced (decompensated) cirrhosis of the liver
  • You have a liver tumour or gallstones
  • Your lung function is significantly reduced, specifically if a breathing test result called FEV1 is below 50% of the expected level
  • Your overall health or nutritional state is considered severely compromised

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.

Trial details

Status
Completed
Phase
Not Applicable
Sponsor
Children's Hospital Medical Center, Cincinnati
Registry
clinicaltrials_gov
Start date
1 September 1997

Where this trial is recruiting

🇮🇹 Italy 🇺🇸 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