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NCT03919773 · ClinicalTrials.gov registry record · Phase 1
IVIG (Gamunex-C) Treatment Study for POTS Subjects
A Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03919773: Completed Phase 1 study, sponsored by University of Texas Southwestern Medical Center.
NCT03919773 is a Phase 1 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03919773, a Phase 1 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this trial is to evaluate the symptomatic benefits of immunomodulatory treatment with IVIG for POTS (postural tachycardia syndrome) patients with evidence of autoimmunity.
Primary Outcome
Primary outcome was change in autonomic symptom burden, assessed by total COMPASS-31 (sum of scaled subscores), comparing assessment at week 13 (2 weeks after final infusion) minus the assessment at baseline. This questionnaire generates a weighted score from 0 to 100, and questions fall into one of six domains: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor function. A COMPASS-31 (Composite Autonomic Symptom Score-31) score of ≥20 suggests moderate
Interventions
- DRUG IVIG
- DRUG Albumin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-10-29 |
| Est. Completion | 2023-12-01 |
| Phase | Phase 1 |
What the finished NCT03919773 record still lists
NCT03919773 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which IVIG is the first listed.
NCT03919773 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03919773 about?
NCT03919773 is a clinical study titled "IVIG (Gamunex-C) Treatment Study for POTS Subjects". The purpose of this trial is to evaluate the symptomatic benefits of immunomodulatory treatment with IVIG for POTS (postural tachycardia syndrome) patients with evidence of autoimmunity.
What is the current status of trial NCT03919773?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2018-10-29. Estimated completion is 2023-12-01.
What interventions are being tested in trial NCT03919773?
The interventions under investigation include: IVIG (DRUG), Albumin (DRUG).
Who is sponsoring clinical trial NCT03919773?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03919773's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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
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