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Phase I Pilot Study of Gene Therapy for Cystic Fibrosis Using Cationic Liposome Mediated Gene Transfer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004471
First Posted: October 19, 1999
Last Update Posted: March 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Alabama at Birmingham
October 18, 1999
October 19, 1999
March 29, 2011
August 1995
May 2001   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004471 on ClinicalTrials.gov Archive Site
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Phase I Pilot Study of Gene Therapy for Cystic Fibrosis Using Cationic Liposome Mediated Gene Transfer
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OBJECTIVES:

Determine whether copies of the cystic fibrosis gene (pGT-1) can be delivered to the cells lining the nose of cystic fibrosis patients using cationic liposome (DMRIE/DOPE) mediated gene transfer.

PROTOCOL OUTLINE: Under direct visualization, patients receive lipid/DNA formulation (pGT-1 lipid complex) by syringe instillation over 30 minutes to the right inferior nasal turbinate.

Patients are followed daily for 7 days, twice a week for 3 weeks, every 2-3 weeks for 10 weeks, then every 3 months thereafter.

Interventional
Phase 1
Primary Purpose: Treatment
Cystic Fibrosis
Genetic: pGT-1 gene lipid complex
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
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May 2001   (Final data collection date for primary outcome measure)
  • Cystic fibrosis patients
  • Not pregnant Fertile patients must use effective contraception
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00004471
199/13941
UAB-6097
UAB-F930923001
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University of Alabama at Birmingham
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Study Chair: Eric J. Sorscher University of Alabama at Birmingham
University of Alabama at Birmingham
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP