NCT02005848

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2014

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

2.8 years

First QC Date

November 27, 2013

Last Update Submit

October 10, 2018

Conditions

New Onset Type-1 Diabetes

Keywords

Type-1 DiabetesT1DDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Beta cell function

    Beta cell function (measured by C peptide)

    12 months from baseline

Secondary Outcomes (5)

  • Glycemic control

    12 months from baseline

  • Beta cell function

    12 months from baseline

  • Insulin dose

    12 months from baseline

  • Hypoglycemic episodes

    12 months from baseline

  • Safety parameters

    12 months from baseline

Study Arms (3)

Alpha1 Antitrypsin (Glassia)

EXPERIMENTAL

60 mg/kg body weight

Biological: Alpha-1 Antitrypsin

Alpha-1 Antitrypsin (Glassia)

EXPERIMENTAL

120 mg/kg body weight

Biological: Alpha-1 Antitrypsin

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Alpha-1 AntitrypsinBIOLOGICAL
Also known as: Humman Alpha-1 Antitrypsin, Alpha-1 Proteinase Inhibitor, API, AAT
Alpha-1 Antitrypsin (Glassia)Alpha1 Antitrypsin (Glassia)
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age8 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Soroka Medical Center

Beersheba, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Schneider Children's Medical Center

Pethach Tikva, Israel

Location

Assaf Harofe Medical Center

Ẕerifin, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

alpha 1-Antitrypsin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

GlycoproteinsGlycoconjugatesCarbohydratesSerpinsPeptidesAmino Acids, Peptides, and ProteinsAcute-Phase ProteinsBlood ProteinsProteinsAlpha-GlobulinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2013

First Posted

December 9, 2013

Study Start

April 1, 2014

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

October 11, 2018

Record last verified: 2018-10

Locations

IL(4)