Therapeutics
Gamunex
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Overview
Name: Gamunex
Synonyms: Intravenous Immunoglobulin, Human Albumin Combined With Flebogamma
Therapy Type: Combination, Immunotherapy (passive) (timeline)
Target Type: Amyloid-Related (timeline), Inflammation (timeline)
Condition(s): Alzheimer's Disease
U.S. FDA Status: Alzheimer's Disease (Phase 2/3)
Company: Grifols Biologicals Inc.
Approved for: Immunodeficiency, chronic inflammatory demyelinating neuropathy
Background
This immunoglobulin preparation is used in obstetric indications to prevent and treat blood conditions related to rhesus factor incompatibility. It is one of several IVIg products being tested clinically as an Alzheimer's treatment following Phase 1 and 2 results for Baxter Healthcare's IVIg product, Gammagard™.
Findings
A multicenter Phase 2/3 trial being conducted in Spain is comparing three doses of 5 percent human albumin plus 5 percent immunoglobulin to placebo delivered intravenously in 350 people with mild to moderate Alzheimer's disease. The primary outcome is change on the ADAS-Cog after 14 months of treatment. See clinicaltrials.gov.
Clinical Trial Timeline
- Phase 2/3
- Study completed / Planned end date
- Planned end date unavailable
- Study aborted
| Sponsor | Clinical Trial | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | 2031 | 2032 | 2033 | 2034 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grifols Biologicals Inc. | NCT01561053 |
N=350
|
Last Updated: 03 Oct 2023
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