A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products

A Multicenter, Non-interventional, Observational, Prospective Study to Assess Hypotension in Patients With Primary Immunodeficiency Disease Treated With Bivigam™ (Human 10%) or Other Commercial Human 10% Immune Globulin (Intravenous) (IGIV) Products During Infusion and up to 72 Hours Post Infusion

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03037359

Enrollment

200

Registered

2017-01-31

Start date

2016-12-31

Completion date

2023-06-30

Last updated

2023-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Immune Deficiency Disorder

Keywords

PID

Brief summary

This is a safety study to evaluate the risk of low blood pressure in subjects with Primary Immune Deficiency disorder (PID) treated with Bivigam™ or another commercial product under real world conditions. No study medication will be provided to subjects in this study. Study physicians will make all treatment decisions according to their usual practice and will provide prescriptions for his/her subjects, as appropriate. The only addition is the collection and structured documentation of data generated through usual practice.

Interventions

BIOLOGICALBivigam

Human immune globulin

BIOLOGICALOther

Human immune globulin

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients with PID diagnosis * Current subjects requiring treatment with an IGIV

Exclusion criteria

* Patients not meeting inclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Rate of Hypotension	During infusion and up to 72 hours post infusion.	The number of events of hypotension in subjects treated with Bivigam or other immune globulin intravenous (IGIV) products. Hypotension is defined as a systolic decrease of 30mmHG or a systolic blood pressure less than 90mmHG and clinical symptoms of hypotension including 1 or more of the following: dizziness, light-headedness, fainting (syncope), chest pain, or diaphoresis.

Secondary

Measure	Time frame	Description
Rate of Hepatic Impairment	Throughout the duration of study participation, up to approximately 140 days.	The number of events of hepatic impairment in subjects treated with Bivigam or other immune globulin intravenous products. The criterion for defining hepatic impairment is transaminases three times the upper limit of normal evaluated based upon medical history, treatment history and the presence of co-morbid conditions.
Rate of Renal Impairment	Throughout the duration of study participation, up to approximately 140 days.	The number of events of renal impairment in subjects treated with Bivigam or other immune globulin intravenous. The criterion for defining hepatic impairment is creatinine values greater than three times the upper limit of normal evaluated based upon medical history, treatment history and the presence of co-morbid conditions.
Rates of Other Adverse Events	Throughout the duration of study participation, up to approximately 140 days.	The rates of other adverse events in patients treated with Bivigam™ or other immune globulin intravenous products.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026