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NCT00004471 Clinical Trial

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

Cystic Fibrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004471
Other study ID # 199/13941
Secondary ID UAB-6097UAB-F930
Status Completed
Phase Phase 1
First received October 18, 1999
Last updated March 28, 2011
Start date August 1995

Study information
Verified date March 2011
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date
Est. primary completion date May 2001
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility - Cystic fibrosis patients

- Not pregnant Fertile patients must use effective contraception

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Genetic:
• pGT-1 gene lipid complex

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Alabama at Birmingham
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