deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT00295165

Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease

Randomized, Double-Blind, Placebo-Controlled, Phase 3 Induction Study to Assess the Efficacy and Safety of 6µg Sargramostim (Leukine) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease

Sponsor: Genzyme, a Sanofi Company

Conditions Crohn Disease
Updated 7 times since 2017 Last updated: Dec 2, 2013 Started: Jan 31, 2006 Primary completion: Oct 31, 2006 Completion: Oct 31, 2006
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

This trial was terminated. No reason was provided.

A PHASE3 clinical study on Crohn Disease, this trial is terminated or withdrawn. The trial is conducted by Genzyme, a Sanofi Company and has accumulated 7 data snapshots since 2006. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotTerminated~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 12 months · monthly snapshotTerminated

Change History

7 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE3

  5. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE3

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Terminated PHASE3

  2. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE3

    First recorded

Jan 2006

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Genzyme, a Sanofi Company
Data source: Sanofi

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