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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:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00004471
First received: October 18, 1999
Last updated: March 28, 2011
Last verified: March 2011

October 18, 1999
March 28, 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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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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