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NCT01963143 · ClinicalTrials.gov registry record · Phase 3
Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases
A Phase 3 study, sponsored by Bio Products Laboratory.
- Completed
- Registry status
- Phase 3
- Development phase
- 48
- Enrollment target
NCT01963143 is a Phase 3 study that has completed, run by Bio Products Laboratory. The registered enrollment target is 48 participants.
The verdict
NCT01963143, a Phase 3 study, has completed, sponsored by Bio Products Laboratory.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 48 participants
- Enrollment target
Study Summary
The primary objective is to demonstrate the bioequivalence of Gammaplex® 10 intravenous immunoglobulin (IGIV) and Gammaplex® 5% IGIV with respect to area under the curve within a 28-day dosing interval (AUC0-28) in a cohort of adult subjects. The secondary objectives are to demonstrate the bioequivalence of Gammaplex® 10 IGIV and Gammaplex® 5% IGIV with respect to area under the curve within a 21-day dosing interval (AUC0-21) in adult subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV and Gammaplex 5% IGIV including Immunoglobulin G (IgG) trough levels and to investigate the safety and tolerability of Gammaplex 10 IGIV and Gammaplex 5% IGIV in adults subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV including IgG trough levels and to investigate the safety and tolerability of Gammaplex 10 IGIV in pediatric subjects.
Interventions
- BIOLOGICAL Gammaplex (5%)
- BIOLOGICAL Gammaplex 10
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2014-02 |
| Est. Completion | 2016-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01963143
The ClinicalTrials.gov registry entry for NCT01963143 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bio Products Laboratory, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Gammaplex (5%) is the first listed.
NCT01963143 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01963143 about?
NCT01963143 is a clinical study titled "Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases". The primary objective is to demonstrate the bioequivalence of Gammaplex® 10 intravenous immunoglobulin (IGIV) and Gammaplex® 5% IGIV with respect to area under the curve within a 28-day dosing interval (AUC0-28) in a cohort of adult subjects. The secondary objectives are to demonstrate the bioequiv...
What is the current status of trial NCT01963143?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 48 participants. The study started on 2014-02. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01963143?
The interventions under investigation include: Gammaplex (5%) (BIOLOGICAL), Gammaplex 10 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01963143?
This trial is sponsored by Bio Products Laboratory, which has 9 total clinical trials registered on ClinicalTrials.gov.
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