A Phase 3 interventional study of Alpha-1 MP and 0.9% Sodium Chloride for Injection, USP in Pulmonary Emphysema in Alpha-1 PI Deficiency, sponsored by Grifols Therapeutics LLC. Completed at 52 sites in 17 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Grifols Therapeutics LLC (part of Grifols) · Phase 3, Interventional, and Treatment
This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered weekly by IV infusion for 156 weeks. The study consists of an optional pre-screening phase, Screening Phase, a 156-week Treatment Phase, and an End of Study Visit at Week 160.
64 studies on the registry are indexed under Pulmonary Emphysema; 7 are open to participants now.
This study's enrollment of 345 is above the median of 33 across 49 interventional studies indexed under Pulmonary Emphysema.
Browse Pulmonary Emphysema studies →Grifols Therapeutics LLC is the lead sponsor of 46 studies on the registry; 4 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 13 (100%) have results posted.
First submitted after Grifols Therapeutics LLC became part of Grifols.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Alpha-1 MP 60 mg/kg administered weekly by IV infusion for 156 weeks
Biological: Alpha-1 MP
Alpha-1 MP 120 mg/kg administered weekly by IV infusion for 156 weeks
Biological: Alpha-1 MP
0.9% Sodium Chloride for Injection, USP, administered weekly by IV infusion for 156 weeks
Other: 0.9% Sodium Chloride for Injection, USP
Also known as: Prolastin-C
Also known as: Saline
Change from Baseline in Whole lung PD15 (15th percentile point)
Whole lung PD15 measured by CT scan
Time frame: Week -3 (baseline measure), Week 52, Week 104, Week 130, Week 156
Adverse Events (AEs)
Monitoring of AEs
Time frame: Week -3 through Week 160
Serious Adverse Events (SAEs)
Monitoring of SAEs
Time frame: Week -3 through Week 160
Discontinuations from the study due to AEs
Monitoring of discontinuations due to AEs
Time frame: Week -3 through Week 160
Severe COPD Exacerbations
Severe COPD exacerbations as defined by American Thoracic Society/European Respiratory Society (ATS/ERS) criteria (i.e., COPD exacerbations requiring hospitalization)
Time frame: Week -3 through Week 160
Change from Baseline in PD15 of the basal lung region
PD15 of the basal lung region measure by CT scan
Time frame: Week -3 (baseline measure), Week 52, Week 104, Week 130, Week 156
Change from baseline in carbon monoxide diffusing capacity (DLco)
DLco performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
Time frame: Weeks 26, 52, 78, 104, 130 and 156
Changes from baseline in forced expiratory volume in 1 second (FEV1)
FEV1 performed according to ATS/ERS guidelines
Time frame: Weeks 26, 52, 78, 104, 130 and 156
Change from baseline in Saint George's Respiratory Questionnaire: Minimum value = 0, maximum value = 100, higher scores indicate worse condition
Health-related quality of life assessment tool
Time frame: Weeks 26, 52, 78, 104, 130 and 156
Change from baseline in the EuroQoL (Quality of Life)- 5 Dimension- 5 Level (EQ-5D-5L): Minimum value (for each one of the 5 levels) = 1, maximum value (for each one of the 5 levels) = 5, higher scores indicate worse condition
Heath-related quality of life assessment tool
Time frame: Weeks 26, 52, 78, 104, 130 and 156
Ran from Apr 2014 to primary completion in Jul 2026, 147 months.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 1, 2026: start Nov 2013 → Apr 2014, primary completion Aug 2026 → Jul 2026 and completion Jan 2027 → Aug 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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