Tolerability and Safety of Immune Globulin Subcutaneous Solution and rHuPH20 in Primary Immunodeficiency Diseases (PID)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT01175213
First received: August 3, 2010
Last updated: March 6, 2013
Last verified: March 2013

August 3, 2010
March 6, 2013
July 2010
July 2015   (final data collection date for primary outcome measure)
Long-term tolerability and safety of IGSC given subcutaneously after a subcutaneous administration of recombinant human hyaluronidase (rHuPH20) in subjects with PID [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
To evaluate the long-term tolerability and safety of IGSC given SC after an SC administration of recombinant human hyaluronidase (rHuPH20) in subjects with PID [ Time Frame: 21 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01175213 on ClinicalTrials.gov Archive Site
Long-term efficacy of IGSC given subcutaneously after an administration of rHuPH20 in subjects with PID [ Time Frame: 21 months ] [ Designated as safety issue: No ]
To monitor the long-term efficacy of IGSC given subcutaneously after an administration of rHuPH20 in subjects with PID [ Time Frame: 21 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Tolerability and Safety of Immune Globulin Subcutaneous Solution and rHuPH20 in Primary Immunodeficiency Diseases (PID)
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 purpose of the study is to assess the long-term safety, tolerability, and practicability of the subcutaneous treatment with Immune Globulin Subcutaneous (IGSC) facilitated with recombinant human hyaluronidase (rHuPH20) in subjects with Primary Immunodeficiency Diseases (PID) who have completed Baxter Clinical Study Protocol No. 160603

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Immunodeficiency Diseases (PID)
Biological: Immune Globulin Subcutaneous Solution (IGSC)
Subjects will continue on the same doses of IGSC, adjusted for body weight, and rHuPH20 that were used for the last infusions in Study epoch 2 of Study 160603.
Experimental: Treatment with IGSC
Intervention: Biological: Immune Globulin Subcutaneous Solution (IGSC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
October 2015
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject has completed or is about to complete Baxter Clinical Study Protocol No. 160603. Subjects 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.
  • Subject/caretaker has reviewed, signed and dated informed consent
  • Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

  • Subject has a serious medical condition such that the subject's safety or medical care would be impacted by participation in Study 160902
  • Subject 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, subject is pregnant or has a positive pregnancy test and does not agree to employ adequate birth control measures for the duration of the study
Both
4 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01175213
160902
No
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Not Provided
Study Director: Richard Schiff, MD Baxter Healthcare Corporation
Baxter Healthcare Corporation
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP