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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 is a Phase 3 study that has completed, run by Octapharma. The registered enrollment target is 21 participants.
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.
Interventions
- BIOLOGICAL NewGam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01313507
The ClinicalTrials.gov registry entry for NCT01313507 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Octapharma, which has 43 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NewGam is the first listed.
NCT01313507 reports 0 study locations.
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.
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