Emphysema Clinical Trial
Official title:
A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter, International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients With Emphysema
This is a randomised , placebo controlled, double blind , multicentre, Phase II/III study evaluating the safety and efficacy of Kamada AAT for inhalation in patients with Emphysema caused by Alpha-1 Antitrypsin (AAT) deficiency.
Alpha-1 Antitrypsin Deficiency, also called Alpha-1-Proteinase Inhibitor (API) deficiency, is
a genetic disorder characterized by the production of an abnormal amount of AAT protein and
reduced circulating levels of this protein. Subjects with AAT deficiency are at increased
risk for developing Emphysema. It is believed that this is the result of the chronic activity
of elastase released by cells continually present in the lungs in low numbers.
Three blinded interim analyses have shown that there are no safety issues and no concerns
regarding tolerability.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05825261 -
Exploring Novel Biomarkers for Emphysema Detection
|
||
| Completed |
NCT02999685 -
Home-based Health Management of Chronic Obstructive Lung Disease (COPD) Patients
|
N/A | |
| Completed |
NCT02914340 -
REACH SVS Control Patient Cross-Over Study
|
N/A | |
| Completed |
NCT02232841 -
Electrical Impedance Imaging of Patients on Mechanical Ventilation
|
N/A | |
| Completed |
NCT02238327 -
Longitudinal Evaluation of HIV-associated Lung Disease Phenotypes
|
||
| Withdrawn |
NCT01908933 -
Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema
|
Phase 3 | |
| Completed |
NCT01615484 -
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability
|
N/A | |
| Completed |
NCT01476995 -
Prognostic Indicators as Provided by the EPIC ClearView
|
N/A | |
| Completed |
NCT01710449 -
Evaluation of Regional Ventilation Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen
|
Phase 1 | |
| Suspended |
NCT00523094 -
Vibration Response Imaging (VRI) in Patients That Are Candidates for Undergoing Pulmonary Operation Procedure
|
N/A | |
| Completed |
NCT00475007 -
Clinical Trial to Evaluate the Safety and Effectiveness of the IBV® Valve System for the Treatment of Severe Emphysema
|
N/A | |
| Recruiting |
NCT00129350 -
Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation
|
Phase 1 | |
| Completed |
NCT01953523 -
Safety and Clinical Outcomes Study: SVF Deployment for Orthopedic, Neurologic, Urologic, and Cardio-pulmonary Conditions
|
N/A | |
| Completed |
NCT00000621 -
Feasibility of Retinoic Acid Treatment in Emphysema (FORTE)
|
Phase 2 | |
| Completed |
NCT00005292 -
Alpha1-antitrypsin Deficiency Registry
|
N/A | |
| Recruiting |
NCT04537182 -
Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema
|
N/A | |
| Active, not recruiting |
NCT02713347 -
Advancing Symptom Alleviation With Palliative Treatment
|
N/A | |
| Recruiting |
NCT04302272 -
STRIVE Post-Market Registry Study
|
||
| Completed |
NCT04435327 -
Lung Damage Caused by SARS-CoV-2 Pneumonia (COVID-19)
|
||
| Completed |
NCT03636347 -
A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo.
|
Phase 2 |