CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
IVIG +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03919773
NCT03919773Phase 2Completed
CompareCT.gov

IVIG (Gamunex-C) Study of Treatment for Autoimmune Neuropathic Dysautonomia/Postural Tachycardia (POTS)

University of Texas Southwestern Medical Center·interventional·Posted Apr 18, 2019·Updated Sep 19, 2024

In Brief

A Phase 2 clinical trial evaluating IVIG and Albumin for Postural Tachycardia Syndrome. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostural Tachycardia Syndrome
CountriesUnited States
CollaboratorsGrifols Biologicals, LLC, Dysautonomia International

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 18, 2019
Enrollment StartOct 29, 2018
Primary CompletionJun 26, 2023
Study CompletionDec 1, 2023
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 7.2 years ago

Interventions

IVIGdrug

If you participate in this study there will be 18 scheduled treatment infusions during the 30 week study period. All the study visits and treatment visits will be outpatient visits. Once you qualify to participate in the study and begin treatment, there will be two 12 week treatment periods separated by a 6 week washout period. The infusion visits will take approximately 3-4 hours each.

Albumindrug

This will be the matching placebo used in the study.