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NCT01213043 · ClinicalTrials.gov registry record · Phase 2
Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency
A Phase 2 study, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT01213043: Completed Phase 2 study, sponsored by Grifols Therapeutics.
NCT01213043 is a Phase 2 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01213043, a Phase 2 study, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a study to assess the safety and pharmacokinetics of weekly infusions of 120 mg/kg of Prolastin-C (alpha1-proteinase inhibitor \[alpha1-PI\] \[Human\]), compared to weekly infusions of 60 mg/kg of Prolastin-C in patients with alpha 1-antitrypsin deficiency (AATD).
Primary Outcome
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).
Interventions
- BIOLOGICAL Prolastin-C, 60 mg/kg
- BIOLOGICAL Prolastin-C, 120 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-01 |
| Phase | Phase 2 |
What the finished NCT01213043 record still lists
NCT01213043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Prolastin-C, 60 mg/kg is the first listed.
NCT01213043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01213043 about?
NCT01213043 is a clinical study titled "Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency". This is a study to assess the safety and pharmacokinetics of weekly infusions of 120 mg/kg of Prolastin-C (alpha1-proteinase inhibitor \[alpha1-PI\] \[Human\]), compared to weekly infusions of 60 mg/kg of Prolastin-C in patients with alpha 1-antitrypsin deficiency (AATD).
What is the current status of trial NCT01213043?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2010-11. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01213043?
The interventions under investigation include: Prolastin-C, 60 mg/kg (BIOLOGICAL), Prolastin-C, 120 mg/kg (BIOLOGICAL).
Who is sponsoring clinical trial NCT01213043?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01213043's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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