Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 30 participants.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01213043
The ClinicalTrials.gov registry entry for NCT01213043 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grifols Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Prolastin-C, 60 mg/kg is the first listed.
NCT01213043 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.