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NCT01884311 · ClinicalTrials.gov registry record · Phase 3
Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases
A Phase 3 study, sponsored by Bio Products Laboratory.
- Completed
- Registry status
- Phase 3
- Development phase
- 38
- Enrollment target
NCT01884311: Completed Phase 3 study, sponsored by Bio Products Laboratory.
NCT01884311 is a Phase 3 study that has completed, run by Bio Products Laboratory. The registered enrollment target is 38 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01884311, a Phase 3 study, has completed, sponsored by Bio Products Laboratory.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 38 participants
- Enrollment target
Study Summary
The main objective of the study is to determine the pharmacokinetics profile of Subgam-VF. The secondary objectives are to assess the safety of Subgam-VF and refine the dose adjustment coefficient for Subgam-VF needed for subjects switching from prior intravenous immunoglobulin (IGIV) therapy.
Primary Outcome
Log transformed sAUC0-t, (AUC0-t standardized to one week) were analysed using a multiple linear regression model fitted including treatment, allowing for variability between treatment groups. The mean difference (Subgam-VF or Gammaplex IGIV 5%) between treatments with 90% Confidence Interval (CI) were back transformed to give an estimate of the ratio (Subgam-VF/ Gammaplex 5% IGIV) of sAUC(0-t). Data was collected at the following timepoints after week 21 of the clinical trial over a period of 1
Interventions
- BIOLOGICAL Subgam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2015-08-20 |
| Est. Completion | 2017-05-25 |
| Phase | Phase 3 |
What the finished NCT01884311 record still lists
NCT01884311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Subgam is the first listed.
NCT01884311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01884311 about?
NCT01884311 is a clinical study titled "Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases". The main objective of the study is to determine the pharmacokinetics profile of Subgam-VF. The secondary objectives are to assess the safety of Subgam-VF and refine the dose adjustment coefficient for Subgam-VF needed for subjects switching from prior intravenous immunoglobulin (IGIV) therapy.
What is the current status of trial NCT01884311?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 38 participants. The study started on 2015-08-20. Estimated completion is 2017-05-25.
What interventions are being tested in trial NCT01884311?
The interventions under investigation include: Subgam (BIOLOGICAL).
Who is sponsoring clinical trial NCT01884311?
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 NCT01884311's enrollment target sits among peer trials
38 1900th of 2000 higher than 100 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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