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Clinical Trials/NCT01218438
NCT01218438CompletedPhase 2

A Clinical Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) for the Evaluation of Efficacy, Safety, Tolerability and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases (PIDD)

Baxalta now part of Shire18 sites in 2 countries86 target enrollmentStarted: January 28, 2013Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
86
Locations
18
Primary Endpoint
Rate of Acute Serious Bacterial Infections Per Year (ASBI)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation for the treatment of patients with primary immunodeficiency diseases (PIDD).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
2 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Documented diagnosis of a form of primary humoral immunodeficiency involving defective antibody formation and requiring gammaglobulin replacement as defined according to the IUIS Scientific Committee, 2011 and by diagnostic criteria according to Conley et al. (1999). The diagnosis must be confirmed by the Medical Director prior to first treatment with the investigational product (IP) in the study.
  • •Participant is 2 years or older at the time of screening, and has a minimum body weight of 13 kg.
  • •Written informed consent has been obtained from either the participant or the participant's legally authorized representative prior to any study-related procedures and study product administration
  • •Participant has been receiving a stable monthly equivalent dose of IgG at an average minimum dose equivalent to 300 mg/kg bodyweight (BW)/4 weeks and a maximum dose equivalent to 1.0 gram/kg BW/4 weeks, for a minimum of 12 weeks prior to first treatment with the IP in the study.
  • •Serum trough level of IgG > 500 mg/dL at screening
  • •Participant is willing and able to comply with the requirements of the protocol

Exclusion Criteria

  • •Participant has known history of or is positive at screening for one or more of the following: hepatitis B surface antigen (HBsAg), polymerase chain reaction (PCR) for Hepatitis C virus(HCV), PCR for human immunodeficiency virus (HIV) Type 1/2
  • •Abnormal laboratory values at screening meeting any one of the following criteria (abnormal tests may be repeated once to determine if they are persistent):
  • •Persistent alanine aminotransferase (ALT) and aspartate amino transferase(AST) > 2.5 times the upper limit of normal for the testing laboratory
  • •Persistent severe neutropenia (defined as an absolute neutrophil count [ANC] ≤500/mm^3)
  • •Creatinine clearance (CLcr) value that is < 60% of normal for age and gender either measured, or calculated according to the Cockcroft-Gault formula
  • •Malignancy (other than adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix), unless the disease-free period prior to screening exceeds 5 years
  • •Participant is receiving anti-coagulation therapy (low dose aspirin at ≤325 mg/day is permitted) or has a history of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) or sickle cell disease with crisis within 12 months prior to screening or a history of thrombophilia
  • •Abnormal protein loss (protein losing enteropathy, nephrotic syndrome)
  • •Anemia that would preclude phlebotomy for laboratory studies according to standard practice at the site
  • •Acute serious bacterial infection within 3 months prior to screening
  • •Ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following intravenous immunoglobulin, subcutaneous immunoglobulin, and/or Immune Serum Globulin (ISG) infusions
  • •Severe immunoglobulin A (IgA) deficiency (less than 0.07g/L) with known anti-IgA antibodies and a history of hypersensitivity
  • •Participant is on continuous systemic antibacterial antibiotics at doses sufficient to treat or prevent bacterial infections, and, in the opinion of the investigator, cannot stop these for the duration of the study without putting the patient at risk of increased infections
  • •Participant has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening
  • •Bleeding disorder or thrombocytopenia with a platelet count less than 20,000/μL, or who, in the opinion of the investigator, would be at significant risk of increased bleeding or bruising as a result of subcutaneous therapy
  • •Total protein > 9 g/dL or myeloma or macroglobulinemia (IgM) or paraproteinemia
  • •Severe dermatitis that would preclude adequate sites for safe product administration
  • •Women of childbearing potential meeting any one of the following criteria:
  • •Participant presents with a positive pregnancy test
  • •Participant is breast feeding
  • •Participant intends to begin nursing during the course of the study
  • •Participant does not agree to employ adequate birth-control measures (e.g. intrauterine device, diaphragm or condom [for male partner] with spermicidal jelly or foam, or birth control pills/patches) throughout the course of the study
  • •Participation in another clinical study and exposure to an investigational product or device within 30 days prior to study enrollment (exception: treatment in a previous Baxter immunoglobulin study)
  • •Participant is scheduled to participate in another (non-Baxter) non-observational (interventional) clinical study involving an investigational product or device during the course of the study

Arms & Interventions

Study Epochs 1-4

Experimental

Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.

Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.

Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.

Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.

Intervention: Immune Globulin Intravenous (Human), 10% Solution (Biological)

Study Epochs 1-4

Experimental

Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.

Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.

Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.

Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.

Intervention: Immune Globulin Subcutaneous (Human), 20% Solution (Drug)

Outcomes

Primary Outcomes

Rate of Acute Serious Bacterial Infections Per Year (ASBI)

Time Frame: 1 year

Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per participant. The observation period for each participant starts with the day of the first subcutaneous (SC) infusion in Study Epoch 2 and ends with the day of the End of Study visit.

Secondary Outcomes

  • Bioavailability of IGSC, 20% as Measured by the Ratio of the Geometric Means of Immunoglobulin G (IgG) AUCSC (Epoch 4) to IgG AUCIV,0-τ (Standardized to 1 Week) (Epoch 1) Adjusted for Dose and Dosing Frequency (Participants ≥12 Years Old)(Epoch 1: 3 week IV administration interval: Week 10, 11, 12, 13. Epoch 1: 4 week IV interval: Week 9, 10, 11, 12, 13. Epoch 4 Subcutaneous administration weeks 17, 18)
  • Annual Rate of Sinus Infections Per Participant(1 year)
  • Annual Rate of Days on Antibiotics Per Participant(1 year)
  • Annual Rate of Hospitalizations for Illness or Infection Per Participant(1 year)
  • Annual Rate of Days of Hospitalizations for Illness or Infection Per Participant(1 year)
  • Trough Levels of Anti-Tetanus Antibody(Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2))
  • Trough Levels of Anti-Hepatitis B Antibody(Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2))
  • Pharmacokinetics Parameters for Immunoglobulin G (IgG): Area Under the Curve (AUC)(Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18)
  • Pharmacokinetics Parameters for Immunoglobulin G (IgG): Dose Per Weight-adjusted Area Under the Curve (AUC)(Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18)
  • Annual Rate of All Infections Per Participant(1 year)
  • Annual Rate of Fever Episodes Per Participant(1 year)
  • Annual Rate of Days Off School/Work or Days Unable to Perform Normal Daily Activities Due to Illness or Infection Per Participant(1 year)
  • Annual Rate of Acute (Urgent or Unscheduled) Physician Visits, or Visits to the Emergency Room for Illness or Infection Per Participant(1 year)
  • Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals(Epoch 1: 3 week IV interval- weeks 0, 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 0, 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2))
  • Pharmacokinetics Parameters for Immunoglobulin G (IgG): Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance for Immune Globulin Administered Subcutaneously (IGSC)(Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18)
  • Pharmacokinetics Parameters for Immunoglobulin G (IgG): Minimum Concentration (Cmin)(Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18)
  • Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Area Under the Curve (AUC)(Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18)
  • Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance (CL/F) for Immune Globulin Administered Subcutaneously(Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18)
  • Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Maximum Concentration (Cmax)(Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18)
  • Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Dose Per Weight-adjusted Area Under the Curve (AUC)(Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18)
  • Trough Levels of Anti-Haemophilus Influenza B Antibody(Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2))
  • Pharmacokinetics Parameters for Immunoglobulin G (IgG): Maximum Concentration (Cmax)(Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18)
  • Pharmacokinetics Parameters for Immunoglobulin G (IgG): Time to Maximum Concentration (Tmax)(Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18)
  • Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Time to Maximum Concentration (Tmax)(Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18)
  • Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant(Up to 20 months per subject (throughout entire study))
  • Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant(Within 24 hours of completion of infusion)
  • Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant(Up to 20 months per subject (throughout entire study))
  • Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion(Within 1 hour of completion of infusion)
  • Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Minimum Concentration (Cmin)(Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18)
  • Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table)(29 weeks)
  • Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion(Up to 20 months per subject (throughout entire study))
  • Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant(Within 72 hours of completion of infusion)
  • Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion(Within 72 hours of completion of infusion)
  • Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion(Within 24 hours of completion of infusion)
  • Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant(Within 1 hour of completion of infusion)
  • Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion(Within 72 hours post infusion for Temporally Associated AEs; End of each Study Epoch (Epoch 1, Epoch 2, Epoch 3, and Epoch 4) for Causally Related AEs)
  • Percentage of Infusions Associated With One or More Local Non-serious Adverse Events (Non-SAEs)(Up to 20 months (throughout entire study))
  • Percentage of Participants Reporting One or More Local Non-serious Adverse Events (Non-SAEs)(Up to 20 months (throughout entire study))
  • Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion(Up to 20 months per subject (throughout entire study))
  • Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs(Up to 20 months (throughout entire study))
  • Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs(Up to 20 months (throughout entire study))
  • Percentage of Infusions Tolerated With Intravenous or Subcutaneous Administration(Up to 20 months (throughout entire study))
  • Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age(Up to 20 months (throughout entire study))
  • Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3(Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion)
  • Treatment Satisfaction Questionnaire for Medication (TSQM) - 2 to 12 Years Old(Up to 20 months per subject (throughout entire study))
  • Number of Participants With Laboratory Confirmed Hemolysis That Occurred Following Investigational Product Administration(Epoch 1: 3 week IV interval- weeks 0, 10. Epoch 1: 4 week IV interval- weeks 0, 9. Epoch 3: Subcutaneous (SC) week 9. Epoch 4: SC weeks 17, 18, 40)
  • Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years(Up to 20 months (throughout entire study))
  • Quality of Life- Short-Form 36v2 (SF-36v2) for the Age Group 14 Years and Older(Up to 20 months (throughout entire study))
  • Treatment Satisfaction Questionnaire for Medication (TSQM) - 13 Years and Older(Up to 20 months per subject (throughout entire study))
  • Life Quality Index - 2 to 12 Years Old(Up to 20 months (throughout entire study))
  • Life Quality Index - 13 Years and Older(Up to 20 months per subject (throughout entire study))

Investigators

Sponsor
Baxalta now part of Shire
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (18)

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