Trials / Completed
CompletedNCT00004287
Phase I Study of the Third Generation Adenovirus H5.001CBCFTR in Patients With Cystic Fibrosis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
OBJECTIVES: I. Assess the safety and feasibility of gene transfer with the third generation adenovirus H5.001CBCFTR in patients with cystic fibrosis.
Detailed description
PROTOCOL OUTLINE: H5.001CBCFTR, an adenovirus vector containing the cystic fibrosis transmembrane conductance regulator gene, is administered endobronchially. Cohort of 2 patients receive 1 of 6 H5.001CBCFTR concentrations. There is no intrapatient dose escalation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | H5.001CBCFTR |
Timeline
- Start date
- 1995-11-01
- First posted
- 1999-10-19
- Last updated
- 2005-06-24
Source: ClinicalTrials.gov record NCT00004287. Inclusion in this directory is not an endorsement.