PF-Atlas › Clinical Trials › NCT00004533
Phase I Randomized Study of Adeno-Associated Virus-CFTR Vector in Patients With Cystic Fibrosis
Adeno-associated virus-CFTR vector · Phase 1
Registry ID
NCT00004533
Phase
Phase 1
Status
Completed
Drug / intervention
Adeno-associated virus-CFTR vector
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start
1999-08
Enrollment
19
About this trial
OBJECTIVES: I. Determine the maximum tolerated dose of recombinant adeno-associated virus-CFTR vector in patients with cystic fibrosis. II. Assess the safety of this gene therapy in these patients. III. Assess the in vivo gene transfer of this vector in these patients. IV. Assess the CFTR gene expression and physiologic activity following gene transfer in these patients. V. Assess the clinical impact of CFTR gene expression following gene transfer in these patients. VI. Monitor patient immune response directed against CFTR or vector components following vector administration.
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Medical disclaimer. This page summarizes public trial data for NCT00004533 for information only. It is not medical advice, an endorsement, or an offer to enroll. Confirm details on ClinicalTrials.gov and with a qualified physician.