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Sponsors and Collaborators: |
FDA Office of Orphan Products Development SciClone Pharmaceuticals |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004428 |
OBJECTIVES: I. Evaluate the safety of ascending doses of CPX administered to adult patients with mild cystic fibrosis.
II. Evaluate the pharmacokinetics of ascending doses of CPX in this patient population.
Condition | Intervention | Phase |
---|---|---|
Cystic Fibrosis |
Drug: CPX |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Estimated Enrollment: | 35 |
Study Start Date: | September 1997 |
Estimated Study Completion Date: | October 1999 |
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, dose escalation study.
There are 7 experimental cohorts, each treated with a different oral dose of CPX or placebo. Within each cohort, 4 patients receive a single dose of CPX and 1 patient receives placebo. Each patient is monitored 24 hours postdose. Escalation to the next dose level for each subsequent cohort begins only after the safety data obtained from the previous cohort is reviewed and found not to limit dose escalation.
All patients return for a follow up evaluation 1 week after dosing.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
Study ID Numbers: | 199/13364, SCICLONE-FDA-OP-97-1 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004428 |
Health Authority: | United States: Federal Government |
cardiovascular and respiratory diseases cystic fibrosis genetic diseases and dysmorphic syndromes rare disease |
Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Fibrosis Lung Diseases |
Respiration Disorders Rare Diseases Infant, Newborn, Diseases Pancreatic Diseases Cystic fibrosis |
Pathologic Processes |