Skip to main content

WAVE T1D

  • Status
    Accepting Candidates
  • Age
    9 Years - 20 Years
  • Sexes
    All
  • Healthy Volunteers
    No
I'm interested
Share this study

Objective

This multi-center randomized controlled trial will assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to

Description

The primary objective of this study is to assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons with T1D. The secondary objectives are to assess metabolic and safety endpoints at 2 years and at timepoints between baseline and two years.

Details

Full study title A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) with Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes (WAVE T1D)
Protocol number OCR49198
ClinicalTrials.gov ID NCT07061574
Phase Phase 1/Phase 2

Eligibility

Key Inclusion Criteria:

Recent-onset stage 3 T1D diagnosed by standard ADA criteria, with the ability to be

randomized within 6 months from the date of T1D diagnosis and within 37 days of Screening

Visit.

  • At least one positive T1D auto-antibody.

  • If clearly positive (≥20% above local lab's ULN) at screening, repeat antibody testing for central lab is not required.

  • Insulin auto-antibodies are only considered if exogenous insulin use is

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.