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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01175213
• Date of registration: 03/08/2010
• Prospective Registration: No
• Primary sponsor: Baxalta now part of Shire
• Public title: Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID
• Scientific title: 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
• Date of first enrolment: July 28, 2010
• Target sample size: 66
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01175213
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Study Director
• Affiliation: Shire

Key inclusion & exclusion 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



Age minimum: 2 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Primary Immunodeficiency Diseases (PID)

Intervention(s)

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

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

Biological: IV treatment with IGSC, 10%

Primary Outcome(s)

Annual Rate of Serious Bacterial Infections [Time Frame: Throughout the efficacy period only (from 60 to 729 days)]

Trough Levels of IgG Maintained During the Study Period in Relation to Dose Frequency [Time Frame: Throughout the efficacy period only (from 60 to 729 days)]

Annual Rate of All Infections [Time Frame: Throughout the efficacy period only (from 60 to 729 days)]

Secondary Outcome(s)

Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). [Time Frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.]

Number of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 [Time Frame: Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)]

Number of Participants With AEs Related to Anti-rHuPH20 Titers [Time Frame: Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)]

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") [Time Frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.]

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") [Time Frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.]

Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (G-M). [Time Frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.]

Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (G-M). [Time Frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.]

Percentage of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Interrupted or Stopped for Tolerability Concerns or for AEs [Time Frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.]

Percentage of Participants With AEs Related to Anti-rHuPH20 Titers [Time Frame: Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)]

Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (A-F). [Time Frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.]

Percentage of Infusions Associated With One or More Local AEs (Including and Excluding Infections), at Any Time During the Study [Time Frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.]

Rate of AEs Per Infusion (Including and Excluding Infections) Temporarily Associated With the Infusion [Time Frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.]

Rate of AEs Per Participant (Including and Excluding Infections) Temporarily Associated With the Infusion [Time Frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.]

Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). [Time Frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.]

Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). [Time Frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.]

The Annual Rate of Serious Adverse Events (SAEs), Related and Not Related to Study Drugs [Time Frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.]

Number of All AEs Categorized by MedDRA Preferred Terms, Seriousness, Relatedness to the Study Drug, and Severity (N-Z). [Time Frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.]

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 [Time Frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.]

Rate of All AEs Per Infusion Categorized by MedDRA Preferred Terms, Seriousness and Severity (A-F). [Time Frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.]

Rate of All AEs Per Participant Categorized by MedDRA Preferred Terms, Seriousness and Severity (N-Z). [Time Frame: Throughout entire study period (up to 3 years). Duration of participation for each participant is variable depending on date of enrollment and their anti-rHuPH20 binding antibody titer.]

Percentage of Participants Who Develop Antibodies and Neutralizing Antibodies to rHuPH20 [Time Frame: Throughout entire study period for 160603 (1 year 11 months) and 160902 (2 years 11 months)]

Secondary ID(s)

160902

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/05/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01175213