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A Research Trial of Aralast in New Onset Diabetes (RETAIN)

NCT01183468 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2018-06-13

Study results available
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Summary

The drug Alpha-1 Antitrypsin (AAT, Aralast NP) is being tested in this study as an anti-inflammatory drug (a medication that decreases inflammation, which is part of the body's normal ability to fight infection and respond to injuries) that affects the cells thought to be involved in the development of type 1 diabetes mellitus (T1DM, T1D).

All subjects enrolled in this study have new-onset T1DM (diagnosis of T1DM within 100 days of Visit 0; T1DM diagnosis fulfilling American Diabetes Association standard T1DM criteria). The focus of Part I of this trial (NCT01183468) is pharmacokinetics (PK), pharmacodynamics (PD) and safety. Upon completion of Part I, including a satisfactory safety review, enrollment in Part II (NCT01183455, Phase II Clinical Trial) will begin.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BIOLOGICAL

Aralast NP 45 mg dose

\- 45 mg/kg/week

BIOLOGICAL

Aralast NP 90 mg dose

\- 90 mg/kg/week

BIOLOGICAL

Aralast NP 180 mg dose

\- 180 mg/kg/week

Sponsors & Collaborators

  • Immune Tolerance Network (ITN)

    collaborator NETWORK

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Gordon Weir, MD · Joslin Diabetes Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01183468 on ClinicalTrials.gov