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

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ClinicalTrials.gov Identifier: NCT02005848
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Kamada, Ltd.

Tracking Information
First Submitted Date  ICMJE November 27, 2013
First Posted Date  ICMJE December 9, 2013
Last Update Posted Date October 11, 2018
Study Start Date  ICMJE April 2014
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2013)
Beta cell function [ Time Frame: 12 months from baseline ]
Beta cell function (measured by C peptide)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02005848 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2016)
  • Glycemic control [ Time Frame: 12 months from baseline ]
    Glycemic control expressed in HbA1c level
  • Beta cell function [ Time Frame: 12 months from baseline ]
  • Insulin dose [ Time Frame: 12 months from baseline ]
  • Hypoglycemic episodes [ Time Frame: 12 months from baseline ]
  • Safety parameters [ Time Frame: 12 months from baseline ]
    Adverse events, vital signs, physical examination
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2013)
  • Glycemic control [ Time Frame: 24 months from baseline ]
    Glycemic control expressed in HbA1c level
  • Beta cell function [ Time Frame: 24 months from baseline ]
  • Insulin dose [ Time Frame: 24 months from baseline ]
  • Hypoglycemic episodes [ Time Frame: 24 months from baseline ]
  • Safety parameters [ Time Frame: 24 months from baseline ]
    Adverse events, vital signs, physical examination
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study to Evaluate the Efficacy and Safety of Glassia® in Type-1 Diabetes
Official Title  ICMJE Phase II Study to Evaluate the Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in the Treatment of New Onset Type-1 Diabetes
Brief Summary

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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE New Onset Type-1 Diabetes
Intervention  ICMJE
  • Biological: Alpha-1 Antitrypsin
    Other Names:
    • Humman Alpha-1 Antitrypsin
    • Alpha-1 Proteinase Inhibitor
    • API
    • AAT
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Alpha1 Antitrypsin (Glassia)
    60 mg/kg body weight
    Intervention: Biological: Alpha-1 Antitrypsin
  • Experimental: Alpha-1 Antitrypsin (Glassia)
    120 mg/kg body weight
    Intervention: Biological: Alpha-1 Antitrypsin
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2018)
70
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2013)
192
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02005848
Other Study ID Numbers  ICMJE Kamada-AAT(IV)-011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kamada, Ltd.
Study Sponsor  ICMJE Kamada, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kamada, Ltd.
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP