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NCT00295061 · ClinicalTrials.gov registry record · Phase 3
Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults
A Phase 3 study, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
NCT00295061 is a Phase 3 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 24 participants.
The verdict
NCT00295061, a Phase 3 study, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this clinical study (ChAMP - Comparability pharmacokinetics of Alpha-1 Modified Process) is to compare the pharmacokinetic, safety and tolerability of Alpha-1 Proteinase Inhibitor (Human), modified process (Alpha-1 MP) and Prolastin in adult Alpha1-antitrypsin deficient patients. Patients will be infused intravenously with study drug on a weekly schedule for 24 weeks.
Interventions
- DRUG alpha-1 proteinase inhibitor (human)
- DRUG Alpha-1 MP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2006-05 |
| Est. Completion | 2007-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00295061
The ClinicalTrials.gov registry entry for NCT00295061 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 24 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 alpha-1 proteinase inhibitor (human) is the first listed.
NCT00295061 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00295061 about?
NCT00295061 is a clinical study titled "Comparison of Pharmacokinetic, Safety, Tolerability of Alpha-1 MP and Prolastin In Alpha1-antitrypsin Deficient Adults". The purpose of this clinical study (ChAMP - Comparability pharmacokinetics of Alpha-1 Modified Process) is to compare the pharmacokinetic, safety and tolerability of Alpha-1 Proteinase Inhibitor (Human), modified process (Alpha-1 MP) and Prolastin in adult Alpha1-antitrypsin deficient patients. Pati...
What is the current status of trial NCT00295061?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2006-05. Estimated completion is 2007-02.
What interventions are being tested in trial NCT00295061?
The interventions under investigation include: alpha-1 proteinase inhibitor (human) (DRUG), Alpha-1 MP (DRUG).
Who is sponsoring clinical trial NCT00295061?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
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