Trial record 2 of 103 for:    new onset type 1 diabetes

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

This study is currently recruiting participants.
Verified March 2014 by Kamada, Ltd.
Sponsor:
Information provided by (Responsible Party):
Kamada, Ltd.
ClinicalTrials.gov Identifier:
NCT02005848
First received: November 27, 2013
Last updated: March 30, 2014
Last verified: March 2014
  Purpose

A Pivotal, Phase II-III, 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.

A sample size of 192 patients is planned, with 64 patients randomized to each of the three study groups.

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.

Condition Intervention Phase
New Onset Type-1 Diabetes
Biological: Alpha-1 Antitrypsin
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase II-III Study to Evaluate the Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in the Treatment of New Onset Type-1 Diabetes

Resource links provided by NLM:


Further study details as provided by Kamada, Ltd.:

Primary Outcome Measures:
  • Beta cell function [ Time Frame: 12 months from baseline ] [ Designated as safety issue: No ]
    Beta cell function (measured by C peptide)


Secondary Outcome Measures:
  • Glycemic control [ Time Frame: 24 months from baseline ] [ Designated as safety issue: No ]
    Glycemic control expressed in HbA1c level

  • Beta cell function [ Time Frame: 24 months from baseline ] [ Designated as safety issue: No ]
  • Insulin dose [ Time Frame: 24 months from baseline ] [ Designated as safety issue: No ]
  • Hypoglycemic episodes [ Time Frame: 24 months from baseline ] [ Designated as safety issue: No ]
  • Safety parameters [ Time Frame: 24 months from baseline ] [ Designated as safety issue: Yes ]
    Adverse events, vital signs, physical examination


Estimated Enrollment: 192
Study Start Date: March 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alpha1 Antitrypsin (Glassia)
60 mg/kg body weight
Biological: Alpha-1 Antitrypsin
Other Names:
  • Humman Alpha-1 Antitrypsin
  • Alpha-1 Proteinase Inhibitor
  • API
  • AAT
Experimental: Alpha-1 Antitrypsin (Glassia)
120 mg/kg body weight
Biological: Alpha-1 Antitrypsin
Other Names:
  • Humman Alpha-1 Antitrypsin
  • Alpha-1 Proteinase Inhibitor
  • API
  • AAT
Placebo Comparator: Placebo
Placebo
Other: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   8 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02005848

Locations
Israel
Soroka Medical Center Not yet recruiting
Beer Sheva, Israel
Contact: Eli Hershkovitz, MD         
Principal Investigator: Eli Hershkovitz         
Rambam Medical Center Not yet recruiting
Haifa, Israel
Contact: Naim Shehadeh, Prof.         
Principal Investigator: Naim Shehadeh, Prof., MD         
Schneider Children's Medical Center Not yet recruiting
Pethach Tikva, Israel
Contact: Yael Lebenthal, MD         
Principal Investigator: Yael Lebenthal, MD         
Assaf Harofe Medical Center Recruiting
Zerifin, Israel
Contact: Marianna Rachmiel, MD       rmarianna@gmail.com   
Principal Investigator: Marianna Rachmiel, MD         
Sponsors and Collaborators
Kamada, Ltd.
  More Information

No publications provided

Responsible Party: Kamada, Ltd.
ClinicalTrials.gov Identifier: NCT02005848     History of Changes
Other Study ID Numbers: Kamada-AAT(IV)-011
Study First Received: November 27, 2013
Last Updated: March 30, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Kamada, Ltd.:
Type-1 Diabetes
T1D
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Alpha 1-Antitrypsin
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Protein C Inhibitor
Protease Inhibitors
Trypsin Inhibitors
Serine Proteinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014