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Safety and Efficacy of Recombinant Adeno-Associated Virus containing CFTR in the treatment of Cystic Fibrosis Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Safety and Efficacy of Recombinant Adeno-Associated Virus containing CFTR in the treatment of Cystic Fibrosis conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Safety and Efficacy of Recombinant Adeno-Associated Virus containing CFTR in the treatment of Cystic Fibrosis Clinical research trials and Safety and Efficacy of Recombinant Adeno-Associated Virus containing CFTR in the treatment of Cystic Fibrosis health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Safety and Efficacy of Recombinant Adeno-Associated Virus containing CFTR in the treatment of Cystic Fibrosis. Safety and Efficacy of Recombinant Adeno-Associated Virus containing CFTR in the treatment of Cystic Fibrosis Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Safety and Efficacy of Recombinant Adeno-Associated Virus containing CFTR in the treatment of Cystic Fibrosis clinical trial. Participants oftentimes recieve the most expert healthcare available for their Safety and Efficacy of Recombinant Adeno-Associated Virus containing CFTR in the treatment of Cystic Fibrosis condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Safety and Efficacy of Recombinant Adeno-Associated Virus containing CFTR in the treatment of Cystic Fibrosis  Safety and Efficacy of Recombinant Adeno-Associated Virus containing CFTR in the treatment of Cystic Fibrosis
Safety and Efficacy of Recombinant Adeno-Associated Virus containing CFTR in the treatment of Cystic Fibrosis
For Condition: Cystic Fibrosis
Status: Recruiting
Sponsor(s): Targeted Genetics Coporation , Cystic Fibrosis Foundation
Synopsis: 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).
Details: Cystic Fibrosis is an autosomal recessive disorder with an incidence of approximtely 1 in 33000 live births. It is due to defects in CFTR gene, which is located on chromosome 7. Gene Therapy holds the promise of addressing the primary defect in CF by reconstituting the CFTR function in the lung. tgAAVCF, which has been genetically engineered to contain the CFTR gene, has been extremely well tolerated following single and multiple dose administrations to the nose, sinus, and lung. Dose-dependent gene transfer has been demonstrated. Although vector gene expression has not been detected, evidence consistent with biological activity was observed in maxillary sinus study, and statistically significant changes in the FEV1 and IL-8 levels were observed in the recently completed multidose aerosol study. These findings are worthy of further investigation.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 100
Location and Contact Information:
UAB-Childrens Health System *Recruiting*
Birmingham, Alabama, 35233
United States
Recruiting Valerie Eubanks 205-939-5743
Mass General Hospital *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Monica Ulles 617-726-2804
Childrens Hospital *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Dana Dorman 617-355-3197
The Johns Hopkins Hospital *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting Lois Brass 410-955-9782
UC San Diego *Not yet recruiting*
San Diego, California, 92123
United States
Not yet recruiting Sarah Holland 858-966-8153
University of Florida *Recruiting*
Gainesville, Florida, 32610
United States
Recruiting Marg Humphries 352-846-2286
University of Colorado-The Childrens Hospital *Recruiting*
Denver, Colorado, 80209
United States
Recruiting Sarah Brayshaw 303-398-1263
University of Nebraska *Recruiting*
Omaha, Nebraska, 68198
United States
Recruiting Dee Acquazzino 402-559-6275
Stanford University Medical Center *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Zoe Davies 650-498-5315
University of Pittsburgh Medical Center *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Elizbeth Hartigan 412-692-7060
Washington University, St. Louis *Not yet recruiting*
St. Louis, Missouri, 63110
United States
Not yet recruiting Mary Boyle 314-454-4069
The Minnesota CF Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Brooke Noren 612-625-7995
Additional Information:
Study ID Numbers: 25E01; RAC-0301-569
Study Start Date: June 2003
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073463
Other Cystic Fibrosis Studies:
1. Weight Gain in CF
2. A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children with Cystic Fibrosis
3. Phase I Randomized Study of Adeno-Associated Virus-CFTR Vector in Patients with Cystic Fibrosis
4. Study of Interferon gamma-1b by injection for the treatment of patients with cystic fibrosis
5. Study of Ibuprofen to Preserve Lung Function in Patients with Cystic Fibrosis
Related Studies:
Other Cystic Fibrosis Clinical Trials
Other Florida Clinical Trials
Other Gainesville Clinical Trials
Safety and Efficacy of Recombinant Adeno-Associated Virus containing CFTR in the treatment of Cystic Fibrosis
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