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Immunoglobulin

An Open-Label Study to Evaluate the Efficacy of High-Dose Gammaplex in Children on the Autism Spectrum

Phase 4
Waitlist Available
Led By Isaac Melamed, MD
Research Sponsored by Isaac Melamed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether giving children with autism a treatment called IGIV, which involves antibodies given through an IV, can help reduce inflammation in their brains. The idea is that reducing this inflammation might improve autism symptoms. The treatment works by calming down the immune system with extra antibodies. Intravenous immunoglobulin (IGIV) has been used in various autoimmune and inflammatory diseases, showing potential benefits in reducing symptoms and modulating the immune system.

Eligible Conditions
  • Pervasive Developmental Disorder
  • Autism
  • Asperger's Syndrome
  • Autism Spectrum Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The primary objective is to assess the efficacy of Gammaplex as an immunomodulatory therapy in autistic children with evidence of immune dysfunction.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Gammaplex 5% IGIVExperimental Treatment1 Intervention
Gammaplex 5% IGIV administered intravenously

Find a Location

Who is running the clinical trial?

Bio Products LaboratoryOTHER
27 Previous Clinical Trials
448 Total Patients Enrolled
Isaac MelamedLead Sponsor
Isaac Melamed, MDPrincipal InvestigatorIMMUNOe International Clinical Research Centers
4 Previous Clinical Trials
71 Total Patients Enrolled
~2 spots leftby Dec 2025
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