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Phase I Randomized Study of CPX for the Treatment of Adult Patients With Mild Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT00004428
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
SciClone Pharmaceuticals
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:

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 or disease Intervention/treatment Phase
Cystic Fibrosis Drug: CPX Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 35 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : September 1997
Study Completion Date : October 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Mild cystic fibrosis
  • Not pregnant or nursing Negative pregnancy test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004428

Sponsors and Collaborators
FDA Office of Orphan Products Development
SciClone Pharmaceuticals
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Study Chair: Eduardo Martins SciClone Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00004428    
Other Study ID Numbers: 199/13364
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: January 2000
Keywords provided by FDA Office of Orphan Products Development:
cardiovascular and respiratory diseases
cystic fibrosis
genetic diseases and dysmorphic syndromes
rare disease
Additional relevant MeSH terms:
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Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases