A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) with a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE) Save

Date Added
May 12th, 2020
PRO Number
Pro00096200
Researcher
Tatsiana Beiko

List of Studies

Silhouette
Keywords
Lung, Pulmonary
Summary

Benralizumab is a drug that can potentially reduce the number of exacerbations (attacks of restricted breathing) for people with chronic obstructive pulmonary disease (COPD). Benralizumab is given as an injection under the skin. Eligible participants will have a 50% chance of being placed in the treatment group (Benralizumab 100mg/mL) or a placebo (inactive substance). The study is double blind so neither the treatment team nor the participant will know what treatment they received. The study will take place for a minimum of one year, but can last up to three years. The study will officially end when every participant has completed one year of treatment.

Institution
MUSC
Recruitment Contact
Rachel Millan
8437920260
rmillan@musc.edu

An Open-Label, Multicenter Study to Evaluate the Long-Term Safety of Weekly Intravenous Alpha1-Proteinase Inhibitor (Human), Modified Process 60 mg/kg in Subjects With Pulmonary Emphysema Due to Alpha1-Antitrypsin Deficiency Save

Date Added
July 23rd, 2019
PRO Number
Pro00090675
Researcher
Tatsiana Beiko

List of Studies

Silhouette
Keywords
Lung, Pulmonary, Rare Diseases
Summary

Individuals with alpha-1 antitrypsin (AAT) deficiency, emphysema and who have been enrolled in the SPARTA trial will be invited to participate in this study. This is a two year extension of the SPARTA trial for subjects who did not receive the study drug (Alpha 1 Proteinase Inhibitor) and for those who complete the SPARTA trial. Participants will all receive weekly infusions of Alpha-1 MP 60mg/kg either at MUSC or at home with a home health nurse. All participants will have blood work, pulmonary function test and CT scans done as part of this study. Safety and side effects of all therapies will be monitored.

Institution
MUSC
Recruitment Contact
M. Gwen Blanton
843-792-8438
blantonm@musc.edu

Protocol GTi1201: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Two Dose Regimens (60 mg/kg and 120 mg/kg) of Weekly Intravenous Alpha1-Proteinase Inhibitor (Human) in Subjects with Pulmonary Emphysema due to Alpha1-Antitrypsin Deficiency Save

Date Added
September 9th, 2014
PRO Number
Pro00033459
Researcher
Tatsiana Beiko

List of Studies

Silhouette
Keywords
Breathing, Lung, Pulmonary, Rare Diseases, Shortness of Breath
Summary

Individuals with alpha-1 antitrypsin (AAT) deficiency (AAT blood level lower than 11 micro-moles) and emphysema will be invited to participate in this study. This study will determine the impact of IV Alpha-1 proteinase inhibitor (Alpha-1 MP) on the progression of emphysema in patients with AAT deficiency. A participant in this study would receive any one of the following three therapies: 1) Alpha-1 MP dosed at 60mg/Kg, 2) Alpha-1 MP dosed at 120mg/Kg, or 3) Placebo. Once a subject is enrolled into this study, he/she will be randomly selected to receive only one of the above three therapies. Neither the study investigators nor the participants will know the actual therapy being given to the participants. All the study participants will receive serial chest CT scans to determine if their emphysema progresses over the following 3 years. Participants will have the IV therapies given to them weekly, with some infusions given at MUSC and some at home. Safety and side effects of all therapies will be monitored.

Institution
MUSC
Recruitment Contact
Mary Blanton
843-792-8438
blantonm@musc.edu

Change_preferences

-- OR --

Create_login