EUCTR2013-002290-21-HU
Active, not recruiting
Phase 1
A Phase III, Multicenter, Open-label, Randomized, Two-Period, Crossover Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases - Study to compare Gammaplex 10% & 5% in Primary Immunodeficiency
ConditionsPrimary immunodeficiency diseasesMedDRA version: 17.0Level: PTClassification code 10064859Term: Primary immunodeficiency syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
DrugsGammaplex
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Primary immunodeficiency diseases
- Sponsor
- Bio Products Laboratory Limited
- Enrollment
- 48
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult cohort: The subject is aged 16 to 55 years inclusive, is of either sex, and belongs to any ethnic group.
- •Pediatric cohort: The subject is aged 2 to 15 years inclusive, is of either sex, weighs at least 10 kg, and belongs to any ethnic group.
- •2\. The subject has primary immunodeficiency disease, e.g. common variable immunodeficiency, X\-linked and autosomal forms of agammaglobulinemia, hyper\-IgM syndrome. Isolated deficiency of a single IgG subclass or of specific antibodies without hypogammaglobulinemia per se, does not qualify for inclusion.
- •3\. The subject is currently receiving a licensed IGIV (or investigational stage III, IIIb IGIV) at a dose that has not changed by ± 50% of the mean dose for at least three months before study entry and is between 300 and 800 mg/kg/infusion. The infusion interval must be either every 21 or every 28 days.
- •4\. The subject must have a trough level \= 6 g/L (600 mg/dL). At least one documented trough level must be available from the three months before Screening.
- •5\. The subject must have documentation from the last three consecutive routine IGIV infusions for the following, before the first infusion in this study: dose of IGIV, treatment intervals, and trade name (or identity) of the IGIV treatment.
- •6\. Female subjects of childbearing potential must have a negative result on an HCG\-based pregnancy test at Screening.
- •7\. Females who are or become sexually active must practice contraception using a method of proven reliability for the study duration.
- •8\. The subject is willing to comply with all aspects of the protocol for the duration of the study.
- •9\. The subject has signed an informed consent form and assent form (if applicable).
Exclusion Criteria
- •1\. The subject has a history of any severe anaphylactic reaction to blood or any blood\-derived product.
- •2\. The subject has selective IgA deficiency, history of reaction to products containing IgA, or has a history of antibodies to IgA.
- •3\. The subject has cellular or innate impaired immunity (i.e. only subjects with humoral impaired immunity may be included).
- •4\. The subject has evidence of an active infection at the time of enrolment.
- •5\. The subject has previously completed or withdrawn from this study.
- •6\. The subject is currently receiving, or has received, any investigational agent other than an IGIV within the prior three months.
- •7\. The subject is pregnant or is nursing.
- •8\. The subject has positive results for any of the following at Screening: Serological test for HIV 1 and 2, HCV, or HBsAg
- •NAT for HCV
- •NAT for HIV
Outcomes
Primary Outcomes
Not specified
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