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NCT04786262 · ClinicalTrials.gov registry record · Phase 3

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

A Phase 3 study of Diabetes Mellitus, Type 1 and Severe Hypoglycemia, sponsored by Vertex Pharmaceuticals Incorporated.

Recruiting
Registry status
Phase 3
Development phase
52
Enrollment target
20
Study locations

NCT04786262 is a Phase 3 study of Diabetes Mellitus, Type 1 and Severe Hypoglycemia that is actively recruiting participants, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 52 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT04786262, a Phase 3 study of Diabetes Mellitus, Type 1 and Severe Hypoglycemia, is actively recruiting participants, sponsored by Vertex Pharmaceuticals Incorporated.

RECRUITING
Registry status
Phase 3
Development phase
52 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.

Conditions Studied

Diabetes Mellitus, Type 1 Severe Hypoglycemia Impaired Hypoglycemic Awareness

Interventions

  • BIOLOGICAL VX-880

Study Locations (20)

Other

  • University of Alberta, Edmonton - Edmonton
  • McGill University Health Centre - Montreal
  • Toronto General Hospital (TGH) - Toronto
  • Vancouver General Hospital - Vancouver
  • CHU Lille - Lille
  • Centre de recherche en Biomédecine de Strasbourg - Strasbourg
  • Dresden Center for Islet Transplantation - Dresden
  • IRCCS Ospedale San Raffaele - Milan

California

  • City of Hope - Duarte
  • University of California San Francisco - San Francisco

Illinois

  • Northwestern Organ Transplant Center - Chicago
  • University of Chicago - Chicago

Pennsylvania

  • Hospital of the University of Pennsylvania - Philadelphia
  • University of Pittsburgh Medical Center Montefiore - Pittsburgh

Florida

  • UHealth Diabetes Research Institute - Miami

Maryland

  • Johns Hopkins University - Baltimore

Massachusetts

  • Massachusetts General Hospital - Boston

Texas

  • Baylor Scott and White Research Institute - Dallas

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2021-03-29
Est. Completion 2030-06-30
Phase Phase 3

Sponsor

Vertex Pharmaceuticals Incorporated

191 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04786262

The ClinicalTrials.gov registry entry for NCT04786262 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (96% lower). The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 1 intervention - of which VX-880 is the first listed.

NCT04786262 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Illinois.

Frequently Asked Questions

What is clinical trial NCT04786262 about?

NCT04786262 is a clinical study titled "A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes". This study will evaluate the safety, tolerability and efficacy of VX-880 infusion in participants with Type 1 diabetes (T1D) and impaired awareness of hypoglycemia (IAH) and severe hypoglycemia.

What is the current status of trial NCT04786262?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 52 participants. The study started on 2021-03-29. Estimated completion is 2030-06-30.

What conditions does trial NCT04786262 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Type 1, Severe Hypoglycemia, Impaired Hypoglycemic Awareness.

What interventions are being tested in trial NCT04786262?

The interventions under investigation include: VX-880 (BIOLOGICAL).

Who is sponsoring clinical trial NCT04786262?

This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04786262 being conducted?

This trial has 20 study locations across California, Florida, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.