Trial · NCT01213043
Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency
NCT01213043, Phase 2, Completed, Grifols Therapeutics LLC; results first posted 2013-05-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency. Trials, record NCT01213043. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01213043
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency
- NCT number
- NCT01213043
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Grifols Therapeutics LLC
- Conditions
- Emphysema, Alpha 1-antitrypsin Deficiency (AATD)
- Interventions
- Prolastin-C, 60 mg/kg, Prolastin-C, 120 mg/kg
- First posted
- 2010-10-01
- Last updated
- 2013-05-20
- Results first posted
- 2013-05-20
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Subjects With Treatment-Emergent Adverse Events (TEAEs) | 22 weeks | Number of subjects experiencing at least one TEAE. TEAEs were defined as any adverse event (AE) during the study that began on or after the date of first dose of investigational product (i.e., Prolastin-C). |
| Primary | Subjects With Drug-Related TEAE(s) | 22 weeks | Number of subjects with at least one TEAE that was determined by the Investigator to be either "possibly related" or "related" to the investigational product (i.e., Prolastin-C). |
| Primary | Subjects With Treatment-Emergent Serious Adverse Events (SAEs) | 22 weeks | Number of subjects who experienced at least one treatment-emergent SAE. |
| Primary | Subjects Withdrawn Due to an AE(s) | 22 weeks | Number of subjects who were withdrawn from the study due to at least one AE. |
| Primary | Subjects With Treatment-Emergent Pulmonary Exacerbation(s) | 22 weeks | Number of subjects with at least one treatment-emergent pulmonary exacerbation |
| Primary | Subjects With Severe TEAE(s) or Pulmonary Exacerbation(s) | 22 weeks | Number of subjects who experienced at least one severe TEAE or pulmonary exacerbation. |
| Primary | Number of TEAEs | 22 Weeks | Total number of TEAEs reported. |
| Primary | Number of Drug-related TEAEs | 22 Weeks | Total number of drug-related TEAEs reported |
| Primary | Number of Treatment-Emergent Pulmonary Exacerbations | 22 Weeks | Total number of treatment-emergent pulmonary exacerbations. |
| Secondary | AUC0-7days | Week 8 and Week 18 at the following timepoints: 0 (pre-infusion), completion of first infusion bag, completion of 2nd infusion bag, and 15 min, 30 min, and 1, 2, 4, 8, 24, 48, 120, and 168 hours post-dose | Area Under the Alpha-1 PI Concentration-Time Curve from Day 0 to Day 7 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Subjects With Treatment-Emergent Adverse Events (TEAEs) | 22 weeks | All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C). | participants | NUMBER |
| SECONDARY | AUC0-7days | Week 8 and Week 18 at the following timepoints: 0 (pre-infusion), completion of first infusion bag, completion of 2nd infusion bag, and 15 min, 30 min, and 1, 2, 4, 8, 24, 48, 120, and 168 hours post-dose | Pharmacokinetic (PK) Population, which consisted of all subjects who received investigational product (Prolastin-C) and had sufficient and valid serum concentration data to facilitate calculation of PK parameters. | h*mg/mL | MEAN |
| PRIMARY | Subjects With Drug-Related TEAE(s) | 22 weeks | All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C). | participants | NUMBER |
| PRIMARY | Subjects With Treatment-Emergent Serious Adverse Events (SAEs) | 22 weeks | All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C). | participants | NUMBER |
| PRIMARY | Subjects Withdrawn Due to an AE(s) | 22 weeks | All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C). | participants | NUMBER |
| PRIMARY | Subjects With Treatment-Emergent Pulmonary Exacerbation(s) | 22 weeks | All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C). | participants | NUMBER |
| PRIMARY | Subjects With Severe TEAE(s) or Pulmonary Exacerbation(s) | 22 weeks | All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C). | participants | NUMBER |
| SECONDARY | Mean Trough | Single measurment immediately prior to infusion at Weeks 6, 7, 8, 9 and Weeks 16, 17, 18, 19 | PK Population, which consisted of all subjects who received investigational product (Prolastin-C) and had sufficient and valid serum concentration data to facilitate calculation of PK parameters. | μM | MEAN |
| PRIMARY | Number of TEAEs | 22 Weeks | All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C). | Events | NUMBER |
| PRIMARY | Number of Drug-related TEAEs | 22 Weeks | All safety analyses were performed on the safety population, which comprised of all subjects who were randomized and received at least one dose of investigational product (Prolastin-C). | Events | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Subjects With Treatment-Emergent Adverse Events (TEAEs) | 60 mg/kg Prolastin-C | 23 | participants | ||
| Subjects With Treatment-Emergent Adverse Events (TEAEs) | 120 mg/kg Prolastin-C | 18 | participants | ||
| AUC0-7days | 60 mg/kg Prolastin-C | 203.6 | Standard Deviation 20.48 | h*mg/mL | |
| AUC0-7days | 120 mg/kg Prolastin-C | 344.8 | Standard Deviation 46.53 | h*mg/mL | |
| Subjects With Drug-Related TEAE(s) | 60 mg/kg Prolastin-C | 3 | participants | ||
| Subjects With Drug-Related TEAE(s) | 120 mg/kg Prolastin-C | 1 | participants | ||
| Subjects With Treatment-Emergent Serious Adverse Events (SAEs) | 60 mg/kg Prolastin-C | 0 | participants | ||
| Subjects With Treatment-Emergent Serious Adverse Events (SAEs) | 120 mg/kg Prolastin-C | 0 | participants | ||
| Subjects Withdrawn Due to an AE(s) | 60 mg/kg Prolastin-C | 0 | participants | ||
| Subjects Withdrawn Due to an AE(s) | 120 mg/kg Prolastin-C | 0 | participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 | STARTED | 60 mg/kg - 120 mg/kg Prolastin-C Treatment Sequence | 15 | |
| Treatment Period 1 | STARTED | 120 mg/kg - 60 mg/kg Prolastin-C Treatment Sequence | 15 | |
| Treatment Period 1 | COMPLETED | 60 mg/kg - 120 mg/kg Prolastin-C Treatment Sequence | 15 | |
| Treatment Period 1 | COMPLETED | 120 mg/kg - 60 mg/kg Prolastin-C Treatment Sequence | 15 | |
| Treatment Period 1 | NOT COMPLETED | 60 mg/kg - 120 mg/kg Prolastin-C Treatment Sequence | 0 | |
| Treatment Period 1 | NOT COMPLETED | 120 mg/kg - 60 mg/kg Prolastin-C Treatment Sequence | 0 | |
| Washout Period | STARTED | 60 mg/kg - 120 mg/kg Prolastin-C Treatment Sequence | 15 | |
| Washout Period | STARTED | 120 mg/kg - 60 mg/kg Prolastin-C Treatment Sequence | 15 | |
| Washout Period | COMPLETED | 60 mg/kg - 120 mg/kg Prolastin-C Treatment Sequence | 15 | |
| Washout Period | COMPLETED | 120 mg/kg - 60 mg/kg Prolastin-C Treatment Sequence | 15 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | 60 mg/kg Prolastin-C | 7 | 30 | 9 |
| other | COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | 120 mg/kg Prolastin-C | 5 | 30 | 6 |
| other | Urinary Tract Infection | Infections and infestations | 60 mg/kg Prolastin-C | 3 | 30 | 4 |
| other | Urinary Tract Infection | Infections and infestations | 120 mg/kg Prolastin-C | 0 | 30 | 0 |
| other | Contusion | Injury, poisoning and procedural complications | 60 mg/kg Prolastin-C | 1 | 30 | 1 |
| other | Contusion | Injury, poisoning and procedural complications | 120 mg/kg Prolastin-C | 2 | 30 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | 60 mg/kg Prolastin-C | 2 | 30 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | 120 mg/kg Prolastin-C | 0 | 30 | 0 |
| other | Proteinuria | Renal and urinary disorders | 60 mg/kg Prolastin-C | 2 | 30 | 2 |
| other | Proteinuria | Renal and urinary disorders | 120 mg/kg Prolastin-C | 1 | 30 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 60 mg/kg Prolastin-C | ||
| Total, all-cause mortality | 120 mg/kg Prolastin-C | ||
| Total, other adverse events | 60 mg/kg Prolastin-C | 15 | 30 |
| Total, other adverse events | 120 mg/kg Prolastin-C | 10 | 30 |
| Total, serious adverse events | 60 mg/kg Prolastin-C | 0 | 30 |
| Total, serious adverse events | 120 mg/kg Prolastin-C | 0 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 60 mg/kg Prolastin-C vs 120 mg/kg Prolastin-C: Subjects Withdrawn Due to an AE(s) | Trial comparisons |
| 60 mg/kg Prolastin-C vs 120 mg/kg Prolastin-C: Subjects With Treatment-Emergent Pulmonary Exacerbation(s) | Trial comparisons |
| 60 mg/kg Prolastin-C vs 120 mg/kg Prolastin-C: Subjects With Severe TEAE(s) or Pulmonary Exacerbation(s) | Trial comparisons |
| 60 mg/kg Prolastin-C vs 120 mg/kg Prolastin-C: Subjects With Drug-Related TEAE(s) | Trial comparisons |
| 60 mg/kg Prolastin-C vs 120 mg/kg Prolastin-C: Subjects With Treatment-Emergent Serious Adverse Events (SAEs) | Trial comparisons |
| 60 mg/kg Prolastin-C vs 120 mg/kg Prolastin-C: Subjects With Treatment-Emergent Adverse Events (TEAEs) | Trial comparisons |
| 60 mg/kg Prolastin-C vs 120 mg/kg Prolastin-C: serious adverse events | Trial comparisons |
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/NCT01213043
GET https://conductscience.org/api/trials/v1/NCT01213043/results?page=2