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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: NCT05727800 Completed - Clinical trials for Alpha-1 Antitrypsin Deficiency

A Phase 1, First-in-human Study of VX-668

Start date: February 8, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VX-668 at various doses.

NCT ID: NCT05579431 Completed - Clinical trials for Alpha 1-Antitrypsin Deficiency

A Phase 1, First-in-human Study of VX-634

Start date: October 13, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VX-634 at various doses.

NCT ID: NCT04474197 Completed - Clinical trials for Alpha1-Antitrypsin Deficiency

Evaluation of the Efficacy and Safety of VX-864 in Subjects With the PiZZ Genotype

Start date: July 24, 2020
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-864 in PiZZ subjects.

NCT ID: NCT04174118 Completed - Clinical trials for Alpha 1-Antitrypsin Deficiency

Study of DCR-A1AT in Healthy Adult Volunteers

Start date: October 24, 2019
Phase: Phase 1
Study type: Interventional

This is a research study to test an experimental study drug (belcesiran, also known as DCR-A1AT). This drug is being tested to see if it helps people with a rare condition known as Alpha-1 Antitrypsin Deficiency, or A1ATD. Prior to initiation of this study belcesiran had not yet been tested in humans. All study participants will be randomly assigned to either receive the study drug or a placebo. This will allow for the sponsor to compare the effects of the study drug with that of the placebo. A placebo looks like the study drug but does not contain any of the study drug. The main purpose of the first part of the study is to evaluate the safety profile of the study drug in people who do not have A1ATD. This part of the study will also help find the dose of the study drug that has an acceptable safety profile for testing.

NCT ID: NCT03945292 Completed - Clinical trials for Alpha 1-Antitrypsin Deficiency

Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT)

SEQUOIA
Start date: August 7, 2019
Phase: Phase 2
Study type: Interventional

The purpose of AROAAT2001 (SEQUOIA) is to evaluate the safety, efficacy and tolerability of multiple doses of the investigational product, Fazirsiran Injection, administered subcutaneously to participants with alpha-1 antitrypsin deficiency (AATD).

NCT ID: NCT03815396 Completed - Clinical trials for Alpha-1 Antitrypsin Deficiency

Phase 1 Study to Assess the Safety, PK and PD of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency

rhAAT-Fc
Start date: July 19, 2019
Phase: Phase 1
Study type: Interventional

This is an open-label, 2-part, dose-escalating, Phase 1 study of INBRX-101 (rhAAT-Fc). Part 1 will consist of single ascending dose (SAD) administration of INBRX-101 and Part 2 will consist of multiple ascending dose (MAD) administrations of INBRX-101. The planned dosing schedule is IV every 3 to 4 weeks.

NCT ID: NCT03804021 Completed - Clinical trials for Alpha-1 Antitrypsin Deficiency

Long-Term Follow-up Study of ADVM-043

Start date: December 27, 2018
Phase:
Study type: Observational

ADVM-043-03 is a long-term follow-up (LTFU) study of subjects who participated in the ADVM-043-01 multi-center gene therapy clinical study (ADVANCE) that evaluated ADVM-043 for the treatment of Alpha-1 Antitrypsin (A1AT) deficiency.

NCT ID: NCT03679598 Completed - Emphysema or COPD Clinical Trials

Alvelestat (MPH966) for the Treatment of ALpha-1 ANTitrypsin Deficiency

ATALANTa
Start date: April 8, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, double-blind, randomized (1:1), placebo-controlled, 12-week, proof-of-concept study to evaluate the safety and tolerability as well as the mechanistic effect of oral administration of alvelestat (MPH966) in subjects with confirmed AATD defined as Pi*ZZ, Pi*SZ, Pi*null, or another rare phenotype/genotype known to be associated with either low (serum AAT level <11 μM or <57.2 mg/dL) or functionally impaired AAT including "F" or "I" mutations.

NCT ID: NCT03636347 Completed - COPD Clinical Trials

A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo.

ASTRAEUS
Start date: October 29, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the effect of alvelestat (an oral neutrophil elastase inhibitor) on blood and sputum biomarkers in patients with PiZZ, null or rare variant phenotype/genotype alpha-1 anti-trypsin deficient lung disease. Change in a number of different blood and sputum biomarkers related to lung damage, inflammation and elastase activity will be measured over a 12 week period. The effect on lung function and respiratory symptoms will also be measured.

NCT ID: NCT03459040 Completed - GVHD Clinical Trials

A Proof of Concept Pilot Trial of Alpha-1-Antitrypsin for Pre-Emption Of Steroid-Refractory Acute GVHD

Start date: August 17, 2018
Phase: Phase 2
Study type: Interventional

Bone marrow transplant (BMT) patients can develop graft-versus-host disease (GVHD), a serious and potentially fatal complication. The researchers have developed a blood test to identify patients most at risk for developing severe GVHD. Patients who consent to this study will have their blood tested up to two times after BMT to determine if they are at high risk for severe GVHD. The tests will be performed one week and two weeks after BMT. Patients who are high risk will be treated with a drug called alpha-1-antitrypsin (AAT) to see if it prevents the development of severe GVHD. Patients will receive 16 doses of AAT through a catheter placed into a blood vessel over eight weeks. AAT will be given either in the hospital or the outpatient clinic two times per week. Patients will be followed for the development of severe GVHD for up to four months from the BMT and will continue to be followed at routine clinic visits for up to one year after BMT.