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NCT01313507 · ClinicalTrials.gov registry record · Phase 3
High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam)
A Phase 3 study, sponsored by Octapharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 21
- Enrollment target
NCT01313507: Completed Phase 3 study, sponsored by Octapharma.
NCT01313507 is a Phase 3 study that has completed, run by Octapharma. The registered enrollment target is 21 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01313507, a Phase 3 study, has completed, sponsored by Octapharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 21 participants
- Enrollment target
Study Summary
This was a prospective, open-label, non-controlled, non-randomized multicenter Phase III study of 2 multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks, continuing the patient's infusion interval in the main study NCT01012323 \[NGAM-01\]) for 3 months. The primary objective of the study was to assess the safety and tolerability of high infusion rates of NewGam.
Primary Outcome
An adverse event was considered to be causally related to the administration of the study drug if it judged to be probably or possibly related to the study drug, as assessed by the investigator.
Interventions
- BIOLOGICAL NewGam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-09 |
| Phase | Phase 3 |
What the finished NCT01313507 record still lists
NCT01313507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which NewGam is the first listed.
NCT01313507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01313507 about?
NCT01313507 is a clinical study titled "High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam)". This was a prospective, open-label, non-controlled, non-randomized multicenter Phase III study of 2 multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks, continuing the patient's infusion interval in the main study NCT01012323 \[NGAM-01\]) for 3 months. The primary objective of ...
What is the current status of trial NCT01313507?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 21 participants. The study started on 2011-05. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01313507?
The interventions under investigation include: NewGam (BIOLOGICAL).
Who is sponsoring clinical trial NCT01313507?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01313507's enrollment target sits among peer trials
21 1953rd of 2000 higher than 45 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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