Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID
Condition: Primary Immunodeficiency Diseases (PID)
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Intervention: SC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety); SC treatment with IGSC, 10% with rHuPH20 followed by IV/IGSC, 10% only (safety); IV treatment with IGSC, 10%
Intervention description: Participants are to continue on the same doses and treatment intervals of IGSC, 10% adjusted for body weight, and rHuPH20 that were used for the last infusions in Study epoch 2 of Study 160603 (NCT00814320).
After 3 infusions, participants are to change treatment to a 2-week interval, if agreed with participant and investigator.
During this safety follow-up period, participants are treated with IGSC, 10% via the SC route. Treatment occurred once every week. The dose was the weekly equivalent of the most recent IV dose (adjusted per body weight) and multiplied by 1.37.; Participants are to continue on the same doses and treatment intervals of IGSC, 10% adjusted for body weight, and rHuPH20 that were used for the last infusions in Study epoch 2 of Study 160603 (NCT00814320).
After 3 infusions, participants are to change treatment to a 2-week interval, if agreed with participant and investigator.
During this safety follow-up period, participants are treated with IGSC, 10% via the intravenous (IV) route. Treatment occurred once every 3-4 weeks. The weekly dose equivalent was 100% of the most recent IV dose.; During this safety follow-up period, participants are treated with IGSC, 10% via the intravenous (IV) route.
Intervention MeSH terms: Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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