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Ingested Interferon Alpha in Newly Diagnosed Type 1 Diabetes
NCT00005665Phase 2
Key facts
- Status
- Unknown
- Countries
- 1
- Sponsor
- National Center for Research Resources
- Modality
- Cytokines & Interferons
- Drugs
- interferon alfa
- Conditions
- type 1 diabetes mellitus (T1D)
01
Overview
Phase 2, randomised, double-blind trial in type 1 diabetes mellitus (T1D) comparing Interferon alpha with Placebo (2 arms). Primary endpoint: C-peptide levels released after Sustacal stimulation at 12 months. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Interferon alpha
30,000 units ingested human recombinant interferon-alpha
Placebo
Ingested placebo
03
Who it enrols
Newly diagnosed type 1 diabetes patients aged 3 to 25, excluding those on immunosuppressive/immunostimulatory medications, with history of alcoholism, or significant organ disease.
04
Endpoints
Primary
C-peptide levels released after Sustacal stimulation
Secondary
Islet cell antibodies titers
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