Alpha 1-Antitrypsin Deficiency Clinical Trial
Official title:
A Phase 1 Study of Inhaled KB408 for the Treatment of Alpha-1 Antitrypsin Deficiency
The Sponsor is developing KB408, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human SERPINA1 to the airways of people with alpha-1 antitrypsin deficiency (AATD) via nebulization. This study is designed to evaluate safety and pharmacodynamics of KB408 in adults with AATD with a PI*ZZ or PI*ZNull genotype. Three planned dose levels of KB408 will be evaluated in single dose escalation cohorts. Subjects taking intravenous AAT augmentation therapy are not required to wash out from IV AAT in the low and mid dose cohorts. At the high dose, two cohorts will be conducted in parallel to evaluate patients on and off IV augmentation therapy.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05687474 -
Baby Detect : Genomic Newborn Screening
|
||
| Recruiting |
NCT03285100 -
The Effects of Discontinuation of Vitamin K Antagonists on the Rate of Elastin Degradation
|
N/A | |
| Completed |
NCT03636347 -
A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo.
|
Phase 2 | |
| Completed |
NCT00396006 -
Efficacy and Safety Study of Augmentation Therapy With ARALAST Fraction IV-1 (Human Alpha 1 - Proteinase Inhibitor)
|
Phase 4 | |
| Completed |
NCT04174118 -
Study of DCR-A1AT in Healthy Adult Volunteers
|
Phase 1 | |
| Completed |
NCT05579431 -
A Phase 1, First-in-human Study of VX-634
|
Phase 1 | |
| Recruiting |
NCT05856331 -
Study of INBRX-101 Compared to Plasma-derived A1PI Therapy in Adults With AATD Emphysema
|
Phase 2 | |
| Suspended |
NCT00571272 -
Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis (LOGIC)
|
||
| Completed |
NCT02168686 -
Safety Dose Finding Study of ADVM-043 Gene Therapy to Treat Alpha-1 Antitrypsin (A1AT) Deficiency
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04204252 -
Evaluate Efficacy and Safety of "Kamada-AAT for Inhalation" in Patients With AATD
|
Phase 3 | |
| Completed |
NCT00067756 -
4-PBA: Will it Increase the Level of Alpha 1-Antitrypsin(AAT) in Persons With AAT Deficiency?
|
Phase 2 | |
| Not yet recruiting |
NCT06389877 -
A Study to Evaluate the Safety and Efficacy of BEAM-302 in Adult Patients With Alpha-1 Antitrypsin Deficiency (AATD)
|
Phase 1/Phase 2 | |
| Completed |
NCT00295061 -
Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults
|
Phase 3 | |
| Completed |
NCT00001462 -
Characterization of the Pathobiology of Early Lung Destruction in Alpha 1-Antitrypsin Deficient Individuals
|
N/A | |
| Active, not recruiting |
NCT05297812 -
Alpha-1 Antitrypsin Disease Cohort: Longitudinal Biomarker Study of Disease
|
||
| Completed |
NCT03114020 -
Efficacy/Safety of HA Inhalation Solution for Hereditary Emphysema in Patients With Alpha-1 Antitrypsin Deficiency
|
Phase 2 | |
| Completed |
NCT00460096 -
Phase II/III Study of an Alpha-1 Proteinase Inhibitor (Kamada-API) in Individuals With Alpha-1 Antitrypsin Deficiency
|
Phase 2/Phase 3 | |
| Completed |
NCT00377416 -
Experimental Gene Transfer Procedure to Treat Alpha 1-Antitrypsin Deficiency
|
Early Phase 1 | |
| Terminated |
NCT00005098 -
Study of Genotype and Phenotype in Patients With Alpha 1-Antitrypsin Deficiency
|
N/A | |
| Completed |
NCT03362242 -
Study of ARO-AAT in Normal Adult Volunteers
|
Phase 1 |