Phase 3
Completed N=66
Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID
Primary Immunodeficiency Diseases (PID)
Source: ClinicalTrials.gov NCT01175213 ↗
Enrolled (actual)
66
Serious AEs
10.5%
Results posted
May 2016
Primary outcomePrimary: Annual Rate of Serious Bacterial Infections — 0.020 Estimated infections/year — p=<0.0001
◆ Published Evidence
Established
50citations · ~5 / year
Long-Term Tolerability, Safety, and Efficacy of Recombinant Human Hyaluronidase-Facilitated Subcutaneous Infusion of Human Immunoglobulin for Primary Immunodeficiency.
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.
Linked Publications (2)
-
Long-Term Tolerability, Safety, and Efficacy of Recombinant Human Hyaluronidase-Facilitated Subcutaneous Infusion of Human Immunoglobulin for Primary Immunodeficiency.
-
Infection rates and tolerability of three different immunoglobulin administration modalities in patients with primary immunodeficiency diseases.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annual Rate of Serious Bacterial Infections |
0.020 | <0.0001 sig |
| PRIMARY Annual Rate of All Infections |
2.86 | — |
| PRIMARY Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency |
10.900; 12.300; 9.760 | — |
| SECONDARY The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs |
0.0000; 0.0000; 0.0000; 0.0000; 0.0768; 0.0000 | — |
| SECONDARY Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs |
1.3; 0.3; 0.8; 0.2; 0.1; 0.2 | — |
| SECONDARY Percentage of Infusions Associated With One or More Moderate or Severe AEs (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of an Infusion |
3.4; 4.7; 2.9; 4.0 | — |
| SECONDARY Number of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 |
13; 0 | — |
| SECONDARY Percentage of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 |
19.7; 0 | — |
| SECONDARY Number of Participants With AEs Related to Anti-rHuPH20 Titers |
12 | — |
| SECONDARY Percentage of Participants With AEs Related to Anti-rHuPH20 Titers |
92.3 | — |
| SECONDARY Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). |
6; 0; 1; 0; 0; 1 | — |
| SECONDARY Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). |
1; 0; 1; 0; 3; 0 | — |
| SECONDARY Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). |
11; 5; 2; 0; 1; 0 | — |
| SECONDARY Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). |
0.095; 0; 0.016; 0; 0; 0.020 | — |
| SECONDARY Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). |
0.016; 0; 0.016; 0; 0.048; 0 | — |
| SECONDARY Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). |
0.175; 0.098; 0.032; 0; 0.016; 0 | — |
| SECONDARY Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). |
0.004; 0; 0.001; 0; 0.002; 0 | — |
| SECONDARY Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). |
0.001; 0; 0.001; 0; 0.002; 0 | — |
| SECONDARY Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). |
0.007; 0.008; 0.001; 0; 0.001; 0 | — |
| SECONDARY Rate of AEs Per Participant (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study ("Related") |
4.635; 2.137; 0.476; 0.392; 0.016; 0.059 | — |
| SECONDARY Rate of AEs Per Infusion (Including and Excluding Infections) Determined by the Investigator to be Related to the Study Drug That Occur at Any Time During the Study ("Related") |
0.183; 0.182; 0.019; 0.033; 0.001; 0.005 | — |
| SECONDARY Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion |
5.921; 2.275; 1.111; 0.647; 0.032; 0.059 | — |
| SECONDARY Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion |
0.233; 0.194; 0.044; 0.055; 0.001; 0.005 | — |
| SECONDARY Percentage of Infusions Associated With One or More Local AEs (Including and Excluding Infections), at Any Time During the Study |
8.8; 3.7; 8.7; 3.7 | — |
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
Data sourced from ClinicalTrials.gov (NCT01175213) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.