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Trial · NCT00206661

Safety and Efficacy Study in the Treatment of Pediatric Crohn's Disease

NCT00206661, Phase 1, Phase 2, Terminated, Genzyme, a Sanofi Company

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Safety and Efficacy Study in the Treatment of Pediatric Crohn's Disease. Trials, record NCT00206661. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00206661

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Safety and Efficacy Study in the Treatment of Pediatric Crohn's Disease
NCT number
NCT00206661
Status
Terminated
Phases
Phase 1, Phase 2
Enrollment
22 participants, actual
Lead sponsor
Genzyme, a Sanofi Company
Conditions
Crohn Disease
Interventions
Sargramostim (Leukine), Sargramostim (Leukine)
First posted
2005-09-21
Last updated
2013-12-04

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryCharacterize the safety profile of sargramostim treatment with concomitant corticosteroid induction therapy12 weeks
SecondaryCharacterize the pharmacokinetic, pharmacodynamics properties of sargramostim treatment with concomitant corticosteroid induction therapyWeek 0, 1, and 2
Secondary
Evaluate the efficacy of sargramostim treatment with concomitant corticosteroids as measured by the Pediatric Crohn's Disease Activity Index (PCDAI), Physician's Global Assessment (PGA), and IMPACT-III Questionnaire
PCDAI, PGA: Week -1 to EOS; IMPACT-II: Week 0, 8 and EOS

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00206661

GET https://conductscience.org/api/trials/v1/NCT00206661/registered