BridgeMD
A Study with an active treatment to Assess the Long-term Safety of Weekly Intravenous Product in Subjects with Pulmonary Emphysema due to Alpha1-Antitrypsin Deficiency
EU CTIS ID: 2024-513962-20-00
What this study is testing
The primary objective of this study is to obtain an additional 2 years of safety data for intravenously administered Alpha-1 MP 60 mg/kg/week in subjects with AATD.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- a. Has completed participation in Study GTi1201 (ie, completed Week 156 and Week 160/End-of-Study Visit) Or b. Has experienced a decline in FEV1 at the annualized rate of ≥134.4 mL/year at or after the Week 104 Visit in GTi1201.
- Is willing and able to provide informed consent.
You likely can't join if
- Is unable to physically or mentally undergo a CT scan (eg, unable to fit inside the CT scanner, claustrophobic).
- Has a history of anaphylaxis or severe systemic response to any plasma-derived alpha1-PI preparation or other blood product(s).
- In the opinion of the investigator, is likely to have compliance problems with the protocol and the procedures of the protocol.
- Has any medical condition that the investigator feels might confound the results of the study or pose an additional risk to the subject during study participation.
- Has severe concomitant disease including, but not limited to, congestive heart failure and liver cirrhosis.
- Has primary and/or secondary (metastatic disease) pulmonary malignancy or other current malignancy with <1 year predicted overall survival
See the full eligibility criteria
- a. Has completed participation in Study GTi1201 (ie, completed Week 156 and Week 160/End-of-Study Visit) Or b. Has experienced a decline in FEV1 at the annualized rate of ≥134.4 mL/year at or after the Week 104 Visit in GTi1201.
- Is willing and able to provide informed consent.
- Is unable to physically or mentally undergo a CT scan (eg, unable to fit inside the CT scanner, claustrophobic).
- Has a history of anaphylaxis or severe systemic response to any plasma-derived alpha1-PI preparation or other blood product(s).
- In the opinion of the investigator, is likely to have compliance problems with the protocol and the procedures of the protocol.
- Has any medical condition that the investigator feels might confound the results of the study or pose an additional risk to the subject during study participation.
- Has severe concomitant disease including, but not limited to, congestive heart failure and liver cirrhosis.
- Has primary and/or secondary (metastatic disease) pulmonary malignancy or other current malignancy with <1 year predicted overall survival
- Has a metal object (newly received since starting GTi1201) that might interfere with chest CT quality and quantification. Metal objects include, but are not limited to, cardiac pacemaker, defibrillator, metal prosthetic heart valve, metal projectile, metal weapon fragments, or metal shoulder prosthesis.
- Is a female who is pregnant, breastfeeding or, if of child-bearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; condom or occlusive cap with spermicidal foam/gel/film/cream/suppository; male sterilization; or abstinence) throughout the study.
- Has clinical signs and symptoms of viral infection requiring virus safety testing at the Week 160/End-of-Study Visit or Early Discontinuation Visit in Study GTi1201, and the virus safety test results are indicative of acute or chronic infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or parvovirus B19 (B19V). Note: If the virus safety test results are indicative of acute or chronic infection with HAV, HBV, HCV, HIV, or B19V, the subject will be considered a screen failure and must be withdrawn from the study.
- Has current evidence of smoking, which includes electronic/vapor cigarettes, or has a positive urine cotinine test at the Week 160/End-of-Study Visit in Study GTi1201 that is due to smoking.
- Has current evidence of chronic alcoholism or illicit drug abuse (addiction).
- Is currently participating in another investigational product (IP) study.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Canada
- Russian Federation
- United States
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Canada; Russian Federation; United States; New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.