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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Kamada, Ltd.
Sponsor:
Information provided by (Responsible Party):
Kamada, Ltd.
ClinicalTrials.gov Identifier:
NCT02005848
First received: November 27, 2013
Last updated: July 30, 2014
Last verified: July 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: April 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: April 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005848

Locations
Israel
Soroka Medical Center Recruiting
Beer Sheva, Israel
Contact: Eli Hershkovitz, MD       elih@bgu.ac.il   
Principal Investigator: Eli Hershkovitz         
Rambam Medical Center Recruiting
Haifa, Israel
Contact: Naim Shehadeh, Prof.       n_shehadeh@rambam.health.gov.il   
Principal Investigator: Naim Shehadeh, Prof., MD         
Schneider Children's Medical Center Recruiting
Pethach Tikva, Israel
Contact: Yael Lebenthal, MD       Yaell@clalit.org.il   
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: July 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, Type 1
Diabetes Mellitus
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 September 16, 2014