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Alpha 1-Antitrypsin Deficiency clinical trials

View clinical trials related to Alpha 1-Antitrypsin Deficiency.

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NCT ID: NCT02722304 Terminated - Clinical trials for Chronic Obstructive Pulmonary Disease

Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency

Start date: November 2, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to conduct a pilot study to evaluate the safety and efficacy of weekly administration of Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy in subjects with A1PI deficiency and emphysema/ chronic obstructive pulmonary disease (COPD).

NCT ID: NCT02691611 Active, not recruiting - Clinical trials for Alpha 1-Antitrypsin Deficiency

Epigenetic Regulation of Immunity in Alpha-1 Anti-trypsin Deficiency

AATD_Epi
Start date: December 2015
Phase:
Study type: Observational

The investigators hypothesize that environmentally influenced histone modifications regulate AM mediated inflammation, contributing to a variable clinical course of AATD, and may also influence or be influenced by the activity of AAT augmentation therapy.

NCT ID: NCT02547532 Completed - Clinical trials for Alpha-1 Antitrypsin Deficiency

Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency

AATD
Start date: September 2015
Phase:
Study type: Observational

In the context of the increasing evidence of the pathogenetic role of microbiome in COPD, our aim is to determine the total and specific bacterial and viral load in sputa from patients with COPD due to AATD and to correlate these findings with cellular, biochemical and immunological characteristics of sputa. These quantitative data obtained from sputum will be analyzed in the context of the clinical and physiological parameters of the patients.

NCT ID: NCT02525861 Completed - Clinical trials for Alpha1-antitrypsin Deficiency

GLASSIA Safety, Immunogenicity, and Bronchoalveolar Lavage Study

Start date: March 8, 2016
Phase: Phase 3
Study type: Interventional

The purpose of the study is 2-fold: (1) to evaluate the safety and potential immunogenicity of GLASSIA following intravenous (IV) administration via in-line filtration; and (2) to assess the effects of GLASSIA augmentation therapy on the levels of A1PI and various biomarkers in the epithelial lining fluid (ELF) following intravenous (IV) administration at a dosage of 60 milligrams per kilogram (mg/kg) Body weight (BW)/week active alpha1-proteinase inhibitor (A1PI) protein for 25 weeks in participants with emphysema due to congenital A1PI deficiency.

NCT ID: NCT02503683 Terminated - Clinical trials for Antitrypsin Deficiency Liver Disease

A Study of an Investigational Drug, ALN-AAT, in Healthy Adult Subjects and Patients With ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease

Start date: July 9, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered ALN-AAT in Healthy Adult Subjects and Patients with ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease.

NCT ID: NCT02502201 Terminated - Clinical trials for Chronic Obstructive Pulmonary Disease

Environment Effect on Six-Minute Walk Test Performance

6MWTAATD
Start date: October 2015
Phase: N/A
Study type: Interventional

The purpose of this research study is to determine the effect of the environment on six-minute walk test performance in individuals with chronic obstructive pulmonary disease due to alpha-1 antitrypsin deficiency. The aim of the study is to determine the environmental impact on physical performance in this population to determine if any factors influence quality of life. This study was developed to evaluate the efficacy of the using the indoor six-minute walk test to determine eligibility for ambulatory oxygen therapy.

NCT ID: NCT02363946 Terminated - Clinical trials for Alpha-1 Antitrypsin Deficiency

A Study of ARC-AAT in Healthy Volunteer Subjects and Patients With Alpha-1 Antitrypsin Deficiency (AATD)

Start date: February 2015
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the safety and tolerability of escalating doses of ARC-AAT and to evaluate the pharmacokinetics of ARC-AAT and the effect of ARC-AAT on circulating levels of alpha-1 antitrypsin (AAT). The study will consist of two parts, Part A (conducted in healthy volunteers) and Part B (conducted in AATD patients) at up to 9 escalating dose levels with 6 participants per dose level.

NCT ID: NCT02282527 Completed - Clinical trials for Alpha1-antitrypsin Deficiency

A Study to Assess Safety and PK of Liquid Alpha1-Proteinase Inhibitor (Human) in Treating Alpha1-Antitrypsin Deficiency

Start date: October 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Grifols Therapeutics Inc. is conducting a multi-center, randomized, double-blind, crossover study to evaluate the safety, immunogenicity, and pharmacokinetics (PK) of Liquid Alpha1-PI compared to the currently licensed product, Prolastin-C, in subjects with Alpha1-Antitrypsin Deficiency (AATD).

NCT ID: NCT02273349 Withdrawn - Emphysema Clinical Trials

Lung Volume Reduction Coils for Emphysema in Alpha-1 Antitrypsin Deficiency

LuReCAA
Start date: October 2014
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and effectiveness of the RePneu Lung Volume Reduction Coil (LVRC) in patients with Alpha-1-Antitrypsin deficiency (AATD) caused emphysema. The hypothesis is that emphysema in AATD patients shows similar tissue destruction profile was well as symptoms and thus will respond favorably to LVRC treatment, demonstrating improvement in lung function, exercise capacity, and quality of life relative to their baseline status.

NCT ID: NCT02168686 Completed - Clinical trials for Alpha 1-Antitrypsin Deficiency

Safety Dose Finding Study of ADVM-043 Gene Therapy to Treat Alpha-1 Antitrypsin (A1AT) Deficiency

ADVANCE
Start date: November 28, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The ADVANCE study is being conducted by Adverum Biotechnologies, Inc. as an open-label, multicenter, dose-escalation study in order to assess the safety and protein expression of ADVM-043 following a single intravenous or intrapleural administration.