Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03037359
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Biotest Pharmaceuticals Corporation

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.

Condition or disease Intervention/treatment
Primary Immune Deficiency Disorder Biological: Bivigam Biological: Other

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Weeks
Official Title: 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
Actual Study Start Date : December 2016
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021


Group/Cohort Intervention/treatment
Bivigam
Patients with primary immunodeficiency disease treated with Bivigam™
Biological: Bivigam
Human immune globulin

Other IGIV
Patients with primary immunodeficiency disease treated with other IGIVs
Biological: Other
Human immune globulin




Primary Outcome Measures :
  1. Rate of Hypotension [ Time Frame: 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 Outcome Measures :
  1. Rate of Hepatic Impairment [ Time Frame: 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.

  2. Rate of Renal Impairment [ Time Frame: 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.

  3. Rates of Other Adverse Events [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary immunodeficiency disease treated IGIV products.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not meeting inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037359


Contacts
Layout table for location contacts
Contact: Gregory Osgood 561-989-5813 gosgood@biotestpharma.com
Contact: Shailesh Chavan, MD 561-989-5748 schavan@biotestpharma.com

Locations
Layout table for location information
United States, Colorado
Allergy and Clinical Research Group Recruiting
Centennial, Colorado, United States, 80112
Contact: Coordinator         
Sponsors and Collaborators
Biotest Pharmaceuticals Corporation

Additional Information:

Layout table for additonal information
Responsible Party: Biotest Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT03037359     History of Changes
Other Study ID Numbers: 017
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Biotest Pharmaceuticals Corporation:
PID

Additional relevant MeSH terms:
Layout table for MeSH terms
Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs