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

NCT03037359 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-02-01

No results posted yet for this study

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.

Conditions

  • Primary Immune Deficiency Disorder

Interventions

BIOLOGICAL

Bivigam

Human immune globulin

BIOLOGICAL

Other

Human immune globulin

Sponsors & Collaborators

  • ADMA Biologics, Inc.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2022-12-31
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03037359 on ClinicalTrials.gov