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Clinical Trials in the USA / NCT02796937
Enrolling by invitation Phase 3

Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency

NCT02796937 · tracked via the Priya Life Science USA tracker
Sponsor
Grifols Therapeutics LLC
Phase
Phase 3
Started
2016-07
Last updated
2026-06-23

Condition(s) studied

Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency

Investigational drug(s) / intervention(s)

Alpha-1 MP

Alpha-1 MP: Alpha-1 MP 60 mg/kg/week for up to 104 weeks

Study summary

This is a 2-year open-label, multicenter extension of the double-blind, placebo-controlled GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data for intravenously administered Alpha1-MP 60 mg/kg/week in subjects with alpha1-antitrypsin deficiency (AATD).

Eligibility

Sex
ALL
Min age
20 Years
Max age
72 Years
Healthy volunteers
No
Inclusion Criteria: * Has completed participation in Study GTi1201 (ie, completed Week 156 and Week 160/End-of-Study Visit) OR 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 Exclusion Criteria: * Is unable to physically or mentally undergo a CT scan (eg, unable to fit inside the CT scanner, claustrophobic). * 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. * 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.

Primary outcome measure(s)

Trial sites (28)

FacilityCityRegionStatus
Grifols Investigative Site Phoenix Arizona
Grifols Investigative Site Miami Florida
Grifols Investigative Site Wilmington North Carolina
Grifols Investigative Site Portland Oregon
Grifols Investigative Site Charleston South Carolina
Grifols Investigative Site Tyler Texas
Grifols Investigative Site Darlinghurst New South Wales
Grifols Investigative Site Adelaide Australia
Grifols Investigative Site Chermside Australia
Grifols Investigative Site Fitzroy Australia
Grifols Investigative Site Nedlands Australia
Grifols Investigative Site Halifax Canada
Grifols Investigative Site Toronto Canada
Grifols Investigative Site Arhus C Denmark
Grifols Investigative Site Hellerup Denmark
Grifols Investigative Site Tallinn Estonia
Grifols Investigative Site Turku Finland
Grifols Investigative Site Bron Rhone
Grifols Investigative Site Chisinau Moldova
Grifols Investigative Site Auckland New Zealand
Grifols Investigative Site Christchurch New Zealand
Grifols Investigative Site Hamilton New Zealand
Grifols Investigative Site Krakow Poland
Grifols Investigative Site Warsaw Poland
Grifols Investigative Site Barnaul Russia
Grifols Investigative Site Gothenburg Sweden
Grifols Investigative Site Malmö Sweden
Grifols Investigative Site Stockholm Sweden

More Grifols Therapeutics LLC trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02796937 on ClinicalTrials.gov ↗ ← All trials in the USA