EUCTR2016-003438-26-GRActive, not recruitingPhase 1
Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects with Primary Immunodeficiency Diseases
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Baxalta US Inc.
- Enrollment
- 42
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Subject must have a documented diagnosis of a form of primary humoral immunodeficiency involving a defect in antibody formation and requiring
- •gammaglobulin replacement, as defined according to the IUIS (International Union of Immunological Societies) Scientific Committee 2015 1 prior to enrollment. The diagnosis must be confirmed by the sponsor Medical Director prior to first treatment with IP in the study.
- •2. Subject is at least two and below 18 years of age at the time of screening.
- •3. Subject has been receiving a consistent dose of IgG, administered in compliance with the respective product information for a period of at least three months prior to screening. The average minimum pre-study dose over that interval was equivalent to 300 mg/kg BW/four weeks and a maximum dose equivalent to 1000 mg/kg BW/4 weeks.
- •4. Subject has a serum trough level of IgG > 5 g/L at screening.
- •5. If female of childbearing potential, subject presents with a negative pregnancy test and agrees to employ adequate birth control measures for the duration of the study.
- •6. Subject/legally authorized representative is willing and able to comply with the requirements of the protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Subject has a 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.
- •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):
- •a. Persistent alanine aminotransferase (ALT) and aspartate amino transferase (AST) >2.5 times the upper limit of normal (ULN) for the testing laboratory b. Persistent severe neutropenia (defined as an absolute neutrophil count [ANC] = 500/mm3)
- •3. Subject has anemia that would preclude phlebotomy for laboratory studies, according to standard practice at the site.
- •4. Subject has an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IV immunoglobulin, SC immunoglobulin, and/or Immune Serum Globulin (ISG) infusions.
- •5. Subject has severe immunoglobulin A (IgA) deficiency (less than 7.0 mg/dL) with known anti-IgA antibodies and a history of hypersensitivity. .
- •6. Subject has a known allergy to hyaluronidase.
- •7. Subject has active infection and is receiving antibiotic therapy for the treatment of infection at the time of screening.
- •8. Subject has a bleeding disorder or 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 SC therapy.
- •9. Subject has severe dermatitis that would preclude adequate sites for safe product administration in the opinion of the investigator.
- •10. Subject has participated in another clinical study involving an IP or investigational device within 30 days prior to enrollment or is scheduled to
- •participate in another clinical study involving an IP or investigational device during the course of this study.
- •11. Subject is a family member or employee of the investigator.
- •12. If female, subject is pregnant or lactating at the time of enrollment.
Investigators
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