Phase II Study to Evaluate the Efficacy and Safety of Glassia® in Type-1 Diabetes

Kamada

Status and phase: Completed; Phase 2

Conditions: New Onset Type-1 Diabetes

Treatments: Other: Placebo; Biological: Alpha-1 Antitrypsin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02005848

Kamada-AAT(IV)-011

Details and patient eligibility

About

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Study Evaluating the Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in the Treatment of New Onset Type-1 Diabetes.

The study objectives are:

• To assess the efficacy of intravenous AAT in treatment of new onset Type 1 Diabetes
• To assess the safety and tolerability of intravenous AAT in new onset Type 1 Diabetes pediatric and young adult population.

Enrollment: 70 patients

Sex: All

Ages: 8 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Subject (or parent/guardian) willing and able to sign an informed consent
• Age 8-25 (inclusive) years
• Recently diagnosed with T1DM
• Basal C-peptide ≥ 0.2 pmol/mL
• Positive for at least one diabetes-related autoantibody
• Ability and consent to comply with completion of patient diary
• No significant abnormalities in serum hematology, serum chemistry
• No significant abnormalities in urinalysis
• No significant abnormalities in ECG
• For women of child bearing potential, non-pregnant, non-lactating female patients

Main Exclusion Criteria:

• IgA deficient subjects
• Subjects who have received an active/ live virus vaccine within 4 weeks of the screening date
• Subjects who have received treatment with corticosteroid medication within 2 months prior to screening or any immunosuppressant or cytostatic agent within 6 months prior to screening
• Individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis, to plasma products
• Clinically significant intercurrent illnesses
• Pregnant or lactating women
• Current use of any medication known to influence glucose tolerance
• Current or prior (within the last 60 days prior to screening visit) use of metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors or amylin.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 3 patient groups, including a placebo group

Alpha1 Antitrypsin (Glassia)

Experimental group

Description:

60 mg/kg body weight

Treatment:

Biological: Alpha-1 Antitrypsin

Alpha-1 Antitrypsin (Glassia)

Experimental group

Description:

120 mg/kg body weight

Treatment:

Biological: Alpha-1 Antitrypsin

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo