Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID

Baxalta

Status and phase: Completed; Phase 3

Conditions: Primary Immunodeficiency Diseases (PID)

Treatments: Biological: SC treatment with IGSC, 10% with rHuPH20 followed by IV/IGSC, 10% only (safety); Biological: SC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety); Biological: IV treatment with IGSC, 10%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01175213

160902

Details and patient eligibility

About

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.

Full description

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

Enrollment: 66 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 3 patient groups

SC/IGSC, 10% with rHuPH20 followed by SC of IGSC, 10% (safety)

Experimental group

Description:

Efficacy and safety of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20) followed by Safety of SC of IGSC, 10% only (safety follow-up)

Treatment:

Biological: SC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety)

SC/IGSC, 10% with rHuPH20 followed by IV of IGSC, 10% (safety

Experimental group

Description:

Efficacy and safety of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20) followed by Safety of intravenous (IV) administration of IGSC, 10% only (safety follow-up)

Treatment:

Biological: SC treatment with IGSC, 10% with rHuPH20 followed by IV/IGSC, 10% only (safety)

IV treatment with IGSC, 10% only

Experimental group

Description:

Partial efficacy (trough levels of immunoglobulin G \[IgG\] only) and safety of intravenous (IV) administration of IGSC, 10% only. This was for participants enrolled in the study who had anti-rHuPH20 andibody titer from study160603

Treatment:

Biological: IV treatment with IGSC, 10%