deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT01119833

Study of GMI-1070 for the Treatment of Sickle Cell Pain Crisis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of GMI-1070, A Pan-Selectin Inhibitor, In Subjects Hospitalized For Sickle Cell Vaso-Occlusive Crisis

Sponsor: GlycoMimetics Incorporated

Interventions GMI-1070 Placebo
Updated 11 times since 2017 Last updated: May 7, 2020 Started: May 31, 2010 Primary completion: Dec 31, 2012 Completion: Dec 31, 2013
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01119833, this PHASE2 trial focuses on Pain Crisis and Sickle Cell Disease and remains completed. Sponsored by GlycoMimetics Incorporated, it has been updated 11 times since 2010, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

Patients being admitted to the hospital for pain crisis may be eligible for this study. In addition, patients should be 12-60 years old and have sickle cell types SS or S-beta-thalassemia. People who take part in the study will be evaluated and then randomly assigned to receive either GMI-1070 or a placebo by IV, in addition to all other usual treatments for their pain crisis. During the hospital stay for pain crisis, GMI-1070 or placebo will be given twice a day, and patients will be asked about their pain severity (pain score) at the beginning of the study and every few hours during their hospital stay. Their general health, vital signs, lab tests, and pain medications will also be checked on a regular basis through the hospital stay. When a patient is feeling well enough to go home, the study drug (GMI-1070 or placebo) will be stopped, and the patient may go home. Participants will be asked to come back to clinic for a check-up a few days after leaving the hospital, and one month after leaving the hospital.

Patients being admitted to the hospital for pain crisis may be eligible for this study. In addition, patients should be 12-60 years old and have sickle cell types SS or S-beta-thalassemia. People who take part in the study will be evaluated and then randomly assigned to receive either GMI-1070 or a placebo by IV, in addition to all other usual treatments for their pain crisis.

During the hospital stay for pain crisis, GMI-1070 or placebo will be given twice a day, and patients will be asked about their pain severity (pain score) at the beginning of the study and every few hours during their hospital stay. Their general health, vital signs, lab tests, and pain medications will also be checked on a regular basis through the hospital stay. When a patient is feeling well enough to go home, the study drug (GMI-1070 or placebo) will be stopped, and the patient may go home. Participants will be asked to come back to clinic for a check-up a few days after leaving the hospital, and one month after leaving the hospital.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshotCompleted~Oct 2018 – ~Jun 2020 · 20 months · monthly snapshotCompleted~Jun 2020 – ~Jan 2021 · 7 months · monthly snapshotCompleted~Jan 2021 – ~Apr 2022 · 15 months · monthly snapshotCompleted~Apr 2022 – ~Jul 2024 · 27 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2

  2. Sep 2025 — Present [monthly]

    Completed PHASE2

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  5. Apr 2022 — Jul 2024 [monthly]

    Completed PHASE2

Show 6 earlier versions
  1. Jan 2021 — Apr 2022 [monthly]

    Completed PHASE2

  2. Jun 2020 — Jan 2021 [monthly]

    Completed PHASE2

  3. Oct 2018 — Jun 2020 [monthly]

    Completed PHASE2

  4. Jun 2018 — Oct 2018 [monthly]

    Completed PHASE2

  5. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE2

  6. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

May 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • GlycoMimetics Incorporated
Data source: GlycoMimetics Incorporated

For direct contact, visit the study record on ClinicalTrials.gov .