Trial · NCT03919773

IVIG (Gamunex-C) Treatment Study for POTS Subjects

NCT03919773, Phase 1, Phase 2, Completed, University of Texas Southwestern Medical Center; results first posted 2024-09-19

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. IVIG (Gamunex-C) Treatment Study for POTS Subjects. Trials, record NCT03919773. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03919773

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: IVIG (Gamunex-C) Treatment Study for POTS Subjects
NCT number: NCT03919773
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 30 participants, actual
Lead sponsor: University of Texas Southwestern Medical Center
Conditions: Postural Tachycardia Syndrome
Interventions: IVIG, Albumin
First posted: 2019-04-18
Last updated: 2024-09-19
Results first posted: 2024-09-19

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Symptoms Measured by Change in COMPASS-31 Score (After Initial Treatment Phase)	Baseline,13 weeks	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-to-severe autonomic dysfunction. Higher scores indicate more severe symptoms. A reduction in score (negative change over time) indicates better outcome or response to treatment.
Secondary	Number of Participants With Clinical Improvement	13 weeks	The count of participants with clinical improvement at 13 weeks is being reported here. Clinical improvement was defined as a reduction of the COMPASS-31 total score by 20% or more. Lower scores are associated with improvement and a 20% reduction was used as a meaningful change in previous studies of POTS

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Symptoms Measured by Change in COMPASS-31 Score (After Initial Treatment Phase)	Baseline,13 weeks	The primary outcome measure was assessed only during the first treatment phase and hence, only 15 participants who received IVIG treatment and 13 participants who received Albumin treatment were analyzed for this primary outcome measure. The 1 patient (Albumin- First intervention group) who was a protocol violation was included in the analysis. The 2 patients (1 each from IVIG and Albumin- first intervention groups) with SAEs were not included in the analysis since lost to follow-up.	score on a scale	MEDIAN
SECONDARY	Number of Participants With Clinical Improvement	13 weeks	The secondary outcome measure was assessed only for the first treatment phase and hence, only 15 participants who received IVIG treatment and 13 participants who received Albumin treatment were analyzed for this outcome measure. The 1 patient (Albumin- First intervention group) who was a protocol violation was included in this analysis . The 2 patients (1 each from IVIG and Albumin- first intervention groups) with SAEs were not included in the analysis since lost to follow-up.	participants	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Symptoms Measured by Change in COMPASS-31 Score (After Initial Treatment Phase)	Treatment IVIG Arm	-5.5	Full Range -27 to 21	score on a scale
Change in Symptoms Measured by Change in COMPASS-31 Score (After Initial Treatment Phase)	Treatment Albumin Arm	-10.6	Full Range -28 to 2	score on a scale
Number of Participants With Clinical Improvement	Treatment IVIG Arm	7		participants
Number of Participants With Clinical Improvement	Treatment Albumin Arm	5		participants

Source ClinicalTrials.gov

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention- (12 Weeks)	STARTED	IVIG First, Then Albumin	16
First Intervention- (12 Weeks)	STARTED	Albumin First, Then IVIG	14
First Intervention- (12 Weeks)	COMPLETED	IVIG First, Then Albumin	15
First Intervention- (12 Weeks)	COMPLETED	Albumin First, Then IVIG	12
First Intervention- (12 Weeks)	NOT COMPLETED	IVIG First, Then Albumin	1
First Intervention- (12 Weeks)	NOT COMPLETED	Albumin First, Then IVIG	2
Washout (6 Weeks)	STARTED	IVIG First, Then Albumin	15
Washout (6 Weeks)	STARTED	Albumin First, Then IVIG	12
Washout (6 Weeks)	COMPLETED	IVIG First, Then Albumin	12
Washout (6 Weeks)	COMPLETED	Albumin First, Then IVIG	12

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Treatment IVIG Arm	18	28	18
other	Headache	Nervous system disorders	Treatment Albumin Arm	14	26	14
other	Fatigue	General disorders	Treatment IVIG Arm	8	28	8
other	Fatigue	General disorders	Treatment Albumin Arm	9	26	9
other	Pain	General disorders	Treatment IVIG Arm	8	28	8
other	Pain	General disorders	Treatment Albumin Arm	8	26	8
other	Rash	Skin and subcutaneous tissue disorders	Treatment IVIG Arm	8	28	8
other	Rash	Skin and subcutaneous tissue disorders	Treatment Albumin Arm	2	26	2
other	gastrointestinal symptom	Gastrointestinal disorders	Treatment IVIG Arm	6	28	6
other	gastrointestinal symptom	Gastrointestinal disorders	Treatment Albumin Arm	5	26	5

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Treatment IVIG Arm	0	28
Total, all-cause mortality	Treatment Albumin Arm	0	26
Total, other adverse events	Treatment IVIG Arm	25	28
Total, other adverse events	Treatment Albumin Arm	22	26
Total, serious adverse events	Treatment IVIG Arm	2	28
Total, serious adverse events	Treatment Albumin Arm	2	26

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28644253	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Treatment IVIG Arm vs Treatment Albumin Arm: deaths from any cause	Trial comparisons
Treatment IVIG Arm vs Treatment Albumin Arm: Number of Participants With Clinical Improvement	Trial comparisons
Treatment IVIG Arm vs Treatment Albumin Arm: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03919773

GET https://conductscience.org/api/trials/v1/NCT03919773/registered

API reference For AI assistants