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NCT00220766 · ClinicalTrials.gov registry record · Phase 3
Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients
A Phase 3 study, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
NCT00220766 is a Phase 3 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 100 participants.
The verdict
NCT00220766, a Phase 3 study, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
Study Summary
The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% caprylate/chromatography (IGIV-C)purified is similar when infused at two different infusion rates. The primary objective is to compare the incidence and severity of all infusion related adverse events when IGIV-C, 10% is administered at a rate of 0.14 mL/kg/min compared to a rate of 0.08 mL/kg/min after a single daily infusion.
Interventions
- DRUG Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
- DRUG Dextrose, 5% in Water
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2002-08 |
| Est. Completion | 2004-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00220766
The ClinicalTrials.gov registry entry for NCT00220766 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 100 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 Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified is the first listed.
NCT00220766 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00220766 about?
NCT00220766 is a clinical study titled "Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients". The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% caprylate/chromatography (IGIV-C)purified is similar when infused at two different infusion rates. The primary objective is to compare the incidence and severity of all infusion rel...
What is the current status of trial NCT00220766?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2002-08. Estimated completion is 2004-03.
What interventions are being tested in trial NCT00220766?
The interventions under investigation include: Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified (DRUG), Dextrose, 5% in Water (DRUG).
Who is sponsoring clinical trial NCT00220766?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
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