Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01828294 · ClinicalTrials.gov registry record · Phase 1
Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis
A Phase 1 study, sponsored by St. Louis University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT01828294: Clinical Trial Phase 1 study, sponsored by St. Louis University.
NCT01828294 is a Phase 1 study that was terminated before completion, run by St. Louis University. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01828294, a Phase 1 study, was terminated before completion, sponsored by St. Louis University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
The study is being done with patients with Myasthenia Gravis (MG), age 18-80 years, positive acetylcholine receptor antibody, receiving greater than 30mg of prednisone daily. Patients may or may not be receiving anticholinesterase agents. A common treatment for patients with this disease includes the administration of intravenous immunoglobulin (IVIG), which is a plasma protein that is given to help maintain adequate antibody levels to prevent infections and decrease the symptoms of the disease of Myasthenia Gravis. This study is being done to test if giving this medication in a subcutaneous form (into the fat of the abdomen, legs and thighs) will be better tolerated for patients with Myasthenia Gravis.
Primary Outcome
To evaluate feasibility and tolerability of IGSC as a maintenance treatment of generalized MG as measured by treatment adherence and adverse events experienced by the patient. Patients will be asked if they have experienced any of the most commonly known side effects of Hizentra. A case report form detailing any adverse events will be included with every study visit and reviewed with the patient at each visit.
Interventions
- DRUG Subcutaneous immunoglobulins
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2011-10 |
| Est. Completion | 2017-12 |
| Phase | Phase 1 |
Why NCT01828294 stopped before completion
NCT01828294 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Subcutaneous immunoglobulins is the first listed.
NCT01828294 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01828294 about?
NCT01828294 is a clinical study titled "Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis". The study is being done with patients with Myasthenia Gravis (MG), age 18-80 years, positive acetylcholine receptor antibody, receiving greater than 30mg of prednisone daily. Patients may or may not be receiving anticholinesterase agents. A common treatment for patients with this disease includes th...
What is the current status of trial NCT01828294?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2011-10. Estimated completion is 2017-12.
What interventions are being tested in trial NCT01828294?
The interventions under investigation include: Subcutaneous immunoglobulins (DRUG).
Who is sponsoring clinical trial NCT01828294?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01828294's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia