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

This study has been completed.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	FDA Office of Orphan Products Development SciClone Pharmaceuticals
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004428

Purpose

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

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	35
Study Start Date:	September 1997
Estimated Study Completion Date:	October 1999

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

Mild cystic fibrosis
Not pregnant or nursing Negative pregnancy test

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004428

Sponsors and Collaborators

FDA Office of Orphan Products Development

SciClone Pharmaceuticals

Investigators

Study Chair:

Eduardo Martins

SciClone Pharmaceuticals

More Information

No publications provided

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 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

cardiovascular and respiratory diseases
cystic fibrosis
genetic diseases and dysmorphic syndromes
rare disease

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis

Lung Diseases
Respiration Disorders
Rare Diseases
Infant, Newborn, Diseases
Pancreatic Diseases

Additional relevant MeSH terms:

Pathologic Processes
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis

Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009