Trial · NCT01983241
Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)
NCT01983241, Phase 3, Completed, Grifols Therapeutics LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD). Trials, record NCT01983241. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01983241
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)
- NCT number
- NCT01983241
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 345 participants, actual
- Lead sponsor
- Grifols Therapeutics LLC
- Conditions
- Pulmonary Emphysema in Alpha-1 PI Deficiency
- Interventions
- Alpha-1 MP, 0.9% Sodium Chloride for Injection, USP
- First posted
- 2013-11-13
- Last updated
- 2026-10-01
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline in Whole lung PD15 (15th percentile point) | Week -3 (baseline measure), Week 52, Week 104, Week 130, Week 156 | Whole lung PD15 measured by CT scan |
| Secondary | Adverse Events (AEs) | Week -3 through Week 160 | Monitoring of AEs |
| Secondary | Serious Adverse Events (SAEs) | Week -3 through Week 160 | Monitoring of SAEs |
| Secondary | Discontinuations from the study due to AEs | Week -3 through Week 160 | Monitoring of discontinuations due to AEs |
| Secondary | Severe COPD Exacerbations | Week -3 through Week 160 | Severe COPD exacerbations as defined by American Thoracic Society/European Respiratory Society (ATS/ERS) criteria (i.e., COPD exacerbations requiring hospitalization) |
| Secondary | Change from Baseline in PD15 of the basal lung region | Week -3 (baseline measure), Week 52, Week 104, Week 130, Week 156 | PD15 of the basal lung region measure by CT scan |
| Secondary | Change from baseline in carbon monoxide diffusing capacity (DLco) | Weeks 26, 52, 78, 104, 130 and 156 | DLco performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines |
| Secondary | Changes from baseline in forced expiratory volume in 1 second (FEV1) | Weeks 26, 52, 78, 104, 130 and 156 | FEV1 performed according to ATS/ERS guidelines |
| Secondary | Change from baseline in Saint George's Respiratory Questionnaire: Minimum value = 0, maximum value = 100, higher scores indicate worse condition | Weeks 26, 52, 78, 104, 130 and 156 | Health-related quality of life assessment tool |
| Secondary | 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 | Weeks 26, 52, 78, 104, 130 and 156 | Heath-related quality of life assessment tool |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25727857 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01983241
GET https://conductscience.org/api/trials/v1/NCT01983241/registered