Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency Clinical Trial
— SPARTA-OLEOfficial title:
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
| Verified date | March 2024 |
| Source | Grifols Therapeutics LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Enrolling by invitation |
| Enrollment | 290 |
| Est. completion date | February 2029 |
| Est. primary completion date | September 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 72 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Adelaide Hospital | Adelaide | |
| Australia | The Prince Charles Hospital | Chermside | |
| Australia | St Vincent's Hospital Sydney | Darlinghurst | New South Wales |
| Australia | St Vincent's Hospital Melbourne | Fitzroy | |
| Australia | Institute for Respiratory Health Inc | Nedlands | |
| Canada | Queen Elizabeth II Health Sciences Centre | Halifax | |
| Canada | Inspiration Research Limited | Toronto | |
| Denmark | Arhus Universitetshospital | Arhus C | |
| Denmark | Gentofte Hospital | Hellerup | |
| Estonia | North Estonia Medical Centre Foundation | Tallinn | |
| Finland | Turun yliopistollinen keskussairaala | Turku | |
| France | CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel | Bron cedex | Rhone |
| New Zealand | NZ Respiratory and Sleep Institute | Auckland | |
| New Zealand | Christchurch Hospital NZ | Christchurch | |
| New Zealand | Waikato Hospital | Hamilton | |
| Poland | SPZOZ Szpital Uniwersytecki w Krakowie | Krakow | |
| Poland | Instytut Gruzlicy i Chorob Pluc w Warszawie | Warszawa | |
| Russian Federation | SBEI HPE Altai State Medical University of MoH and SD | Barnaul | |
| Sweden | Sahlgrenska Sjukhuset | Göteborg | |
| Sweden | Skånes Universitetssjukhus, Malmö | Malmö | |
| Sweden | Karolinska Trial Allicance, KTA Prim | Stockholm | |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | University Of Miami Hospital, Doctors Office West Building | Miami | Florida |
| United States | St. Joseph's Hospital and Medical Center | Phoenix | Arizona |
| United States | Oregon Health & Science University | Portland | Oregon |
| United States | University of Texas Health Center at Tyler | Tyler | Texas |
| United States | Accellacare | Wilmington | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Grifols Therapeutics LLC |
United States, Australia, Canada, Denmark, Estonia, Finland, France, New Zealand, Poland, Russian Federation, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adverse events (AEs) | Monitoring of AEs | Week 1 through Week 108 | |
| Primary | Serious AEs (SAEs) | Monitoring of SAEs | Week 1 through Week 108 | |
| Primary | Discontinuations from the study due to AEs | Monitoring of discontinuations due to AEs | Week 1 through Week 108 | |
| Secondary | Change from baseline in whole lung PD15 (15th percentile point) | Whole lung PD15 measured by computed tomography scans | Week 1 through Week 104 | |
| Secondary | Change from baseline in carbon monoxide diffusing capacity (DLco) | DLco performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines | Week 52 and Week 104 | |
| Secondary | Changes from baseline in forced expiratory volume in 1 second (FEV1) | FEV1 performed according to ATS/ERS guidelines | Week 52 and Week 104 | |
| Secondary | Change from baseline in Saint George's Respiratory Questionnaire | Health-related quality of life assessment tool | Week 52 and Week 104 | |
| Secondary | Incidence and severity of Chronic Obstructive Pulmonary Disease (COPD)exacerbations | Severe COPD exacerbations as defined by ATS/ERS guidelines | Week 2 through Week 108 | |
| Secondary | Change from baseline in the EQ-5D-5L Questionnaire | Heath-related quality of life assessment tool | Week 52 and Week 104 |