Status:
TERMINATED
Safety and Efficacy of Recombinant Adeno-Associated Virus Containing the CFTR Gene in the Treatment of Cystic Fibrosis
Lead Sponsor:
Targeted Genetics Corporation
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to confirm the improvement in pulmonary function and cytokine levels observed in the recently completed multidose aerosol study for the treatment of Cystic Fibrosis (CF).
Detailed Description
Cystic Fibrosis is an autosomal recessive disorder with an incidence of approximately 1 in 33000 live births. It is due to defects in the CFTR gene, which is located on chromosome 7. Gene Therapy hold...
Eligibility Criteria
Inclusion
- Eligible subjects will be randomized to two aerosolized doses of either tgAAVCF or placebo 30 days apart. Subjects will undergo pulmonary function testing every two weeks during the active portion of the study (three months) and will be followed for safety for a total of seven months.
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00073463
Start Date
June 1 2003
End Date
October 1 2005
Last Update
January 28 2008
Active Locations (11)
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1
UAB-Childrens Health System
Birmingham, Alabama, United States, 35233
2
Stanford University Medical Center
Palo Alto, California, United States, 94304
3
UC San Diego
San Diego, California, United States, 92123
4
University of Colorado-The Childrens Hospital
Denver, Colorado, United States, 80209