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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: Completed Phase 3 study, sponsored by Bio Products Laboratory.
NCT01963143 is a Phase 3 study that has completed, run by Bio Products Laboratory. The registered enrollment target is 48 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01963143 record still lists
NCT01963143 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Gammaplex (5%) is the first listed.
NCT01963143 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01963143's enrollment target sits among peer trials
48 1862nd of 2000 higher than 134 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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