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Drug & research development » Clinical trials » NCT00073463

Safety and Efficacy of Recombinant Adeno-Associated Virus Containing the CFTR Gene in the Treatment of Cystic Fibrosis

Official title: A Multicenter, Double-Blind, Placebo Controlled, Phase II Study of Aerosolized tgAAVCF for the Treatment of Cystic Fibrosis

Clinical Trials gov number: NCT00073463

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Purpose: To confirm the improvement in pulmonary function and cytokine levels observed in the recently completed multidose aerosol study for the treatment of CF.

Phase: 2 and 3

Type: Interventional, randomized, double-blind, parallel assignment

Study sponsor: Targeted Genetics Corporation; Cystic Fibrosis Foundation Therapeutics

Study terminated

Intervention
Genetic, tgAAVCF

Geographical Location
United States

Number of Participants
51-100 (≥12 years)

Primary Endpoint

Study terminated

Secondary Endpoint

Study terminated

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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.

Study terminated

View Trial Results