Status:
UNKNOWN
An Open-Label Study to Evaluate the Efficacy of High-Dose Gammaplex in Children on the Autism Spectrum
Lead Sponsor:
Isaac Melamed
Collaborating Sponsors:
Bio Products Laboratory
Conditions:
Autism
Autistic Disorder
Eligibility:
All Genders
4-12 years
Phase:
PHASE4
Brief Summary
If autism is the consequence of a chronic inflammatory process preventing the infant brain from forming the proper neural connections, then treatment that reduces inflammation might have a positive im...
Detailed Description
We have come to believe that an immature immune system with abnormal signaling and altered apoptotic pathways may result in a process of neuroinflammation with a clinical presentation of Autism Spectr...
Eligibility Criteria
Inclusion
- The subject is between the ages of or equal to 4 and 12 years of age, of either gender, and belonging to any ethnic group.
- The subject has a diagnosis, for a minimum of 6 months prior to screening, of either autistic disorder, Asperger disorder, or pervasive developmental disorder (PDD).
- Normal physical test results.
- Immunological lab results showing reduced levels of activated CD40L or abnormal lymphocyte stimulation, or T or B cell dysfunction (hypgammaglobulinemia, primary immunodeficiency (PIDD), or common variable immune deficiency (CVID).
Exclusion
- A diagnosis of isolated IGA deficiency
- Allergic reactions to blood products
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02199925
Start Date
June 1 2013
End Date
July 1 2015
Last Update
April 16 2015
Active Locations (1)
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1
IMMUNOe International Research Centers
Centennial, Colorado, United States, 80112