Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 2 - Any |
| Updated: | 12/29/2018 |
| Start Date: | July 28, 2010 |
| End Date: | August 6, 2013 |
Long-Term Tolerability and Safety of Immune Globulin Subcutaneous (IGSC) Solution Administered Subcutaneously Following Administration of Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Primary Immunodeficiency Diseases
The original purpose of the study is to assess the long-term safety, tolerability, and
practicability of the subcutaneous (SC) treatment with Immune Globulin Subcutaneous Solution
(IGSC), 10% facilitated with recombinant human hyaluronidase (rHuPH20) in participants with
Primary Immunodeficiency Diseases (PID) who have completed Baxter Clinical Study Protocol No.
160603.
Following a discussion with the FDA, all participants still active in the study stopped
treatment with rHuPH20 to assure safety of the participants participating in the study and
went into a safety follow-up.
During this safety follow-up period, participants underwent either intravenous (IV) or SC
treatment with IGSC, 10%. The IV or SC administration route was at the discretion of the
participant and the investigator.
practicability of the subcutaneous (SC) treatment with Immune Globulin Subcutaneous Solution
(IGSC), 10% facilitated with recombinant human hyaluronidase (rHuPH20) in participants with
Primary Immunodeficiency Diseases (PID) who have completed Baxter Clinical Study Protocol No.
160603.
Following a discussion with the FDA, all participants still active in the study stopped
treatment with rHuPH20 to assure safety of the participants participating in the study and
went into a safety follow-up.
During this safety follow-up period, participants underwent either intravenous (IV) or SC
treatment with IGSC, 10%. The IV or SC administration route was at the discretion of the
participant and the investigator.
IGSC, 10% is the same product as IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% (IGIV, 10%) quoted
in study 160603.
IGSC, 10% is abbreviated to IGI, 10% [IMMUNE GLOBULIN INFUSION (HUMAN), 10%]
In the US the product is licensed (trade name GAMMAGARD LIQUID) for the intravenous (IV) and
SC replacement therapy of antibody deficiency in patients with PID.
In the EU this product is licensed (trade name KIOVIG)
IGSC, 10% with rHuPH20 established name is Innume Glubulin Infusion 10% (Human) with
Recombinant Human Hyualuronidase.
US trade name is HYQVIA EU trade name is HyQvia
in study 160603.
IGSC, 10% is abbreviated to IGI, 10% [IMMUNE GLOBULIN INFUSION (HUMAN), 10%]
In the US the product is licensed (trade name GAMMAGARD LIQUID) for the intravenous (IV) and
SC replacement therapy of antibody deficiency in patients with PID.
In the EU this product is licensed (trade name KIOVIG)
IGSC, 10% with rHuPH20 established name is Innume Glubulin Infusion 10% (Human) with
Recombinant Human Hyualuronidase.
US trade name is HYQVIA EU trade name is HyQvia
Inclusion Criteria:
- Participant has completed or is about to complete Baxter Clinical Study Protocol No.
160603. Participants who have discontinued rHuPH20 and reverted to intravenous or
subcutaneous treatment due to an anti-rHuPH20 antibody also may enroll for long-term
safety monitoring.
- Participant/caretaker has reviewed, signed and dated informed consent
- Participant is willing and able to comply with the requirements of the protocol
Exclusion Criteria:
- Participant has a serious medical condition such that the participant's safety or
medical care would be impacted by participation in Study 160902
- Participant is scheduled to participate in another non-Baxter clinical study involving
an investigational product or investigational device during the course of this study
- If female of childbearing potential, participant is pregnant or has a negative
pregnancy test and does not agree to employ adequate birth control measures for the
duration of the study
We found this trial at
11
sites
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