Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-24 @ 5:37 PM
NCT ID:
NCT00430768
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with AAT deficiency
* Forced expiratory volume in one second (FEV1) greater than 24% of predicted value (post bronchodilator)
* Willing to discontinue AAT protein replacement 4 weeks (Group 1) and 8 weeks (Groups 2 and 3) prior to study entry, and to resume 11 weeks after rAAV1-CB-hAAT has been administered
* Willing to discontinue aspirin, aspirin-containing products, and other drugs that may alter platelet function 7 days prior to study entry, and to resume 24 hours after rAAV1-CB-hAAT has been administered
* Willing to use contraception throughout the study
Exclusion Criteria:
* Required antibiotic therapy for a respiratory infection in the 28 days prior to rAAV1-CB-hAAT administration
* Required oral or systemic corticosteroids in the 28 days prior to rAAV1-CB-hAAT administration
* Liver disease
* Currently receiving or has received an investigational study agent in the 30 days prior to study entry
* Received gene transfer agents in the 6 months prior to study entry
* Currently smokes cigarettes or uses illegal drugs
* History of immune response to human AAT replacement
* History of platelet dysfunction
* Abnormal ECG, heart disease, pulmonary edema, or embolism in the 6 months prior to study entry
* Current or recent facial or chest trauma that makes it medically impossible to perform pulmonary function tests (PFTs)
* Any other medical condition that the investigator deems unsuitable for study participation
* Pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00430768
Study Brief:
Protocol Section:
NCT00430768