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Trial · Interventional

CompletedPhase 2Registry data

Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008

NCTNCT00308438 (opens ClinicalTrials.gov in a new tab)Other idCL0600-009
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
67 participants (actual)
Sponsor
Shire · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
2 countries

United States, Canada

Start
1 Mar 2004
Primary completion
1 Nov 2005
Completion
1 Jun 2006
First posted
29 Mar 2006 (estimated)
Last update posted
14 May 2021
Conditions
Crohn's Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2004200520062007
  1. Ph 2

    Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008

    NCT00308438

    1 Mar 2004 to 1 Jun 2006

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.

Interventions

  • Teduglutide (ALX-0600)Drug

Arms1

  • Experimental

    1

    All subjects in the study dosed at 0.1 mg/kg teduglutide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. The percentage of subjects who are in remission (CDAI score less than 150) at week 12 of this study.

    Time frame · 12 weeks after start of study

Secondary outcomes(2)

  1. The percentage of subjects (of those who achieved response in CL0600-008) who, at week 12 of this study, maintain the response they previously achieved.

    Time frame · 12 weeks after study start

  2. The percentage of subjects who did not respond in CL0600-008 who do respond at week 12 in this study

    Time frame · 12 weeks after study start

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2010

7 results

Teduglutide, a novel mucosally active analog of glucagon-like peptide-2 (GLP-2) for the treatment of moderate to severe Crohn's disease.

Buchman et al. 2010Inflammatory bowel diseasescited by 109

PMID 19821509DOI 10.1002/ibd.21117PUB-19821509

Full text at the publisher7 results
Publisher pageSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Subjects must have completed participation in the Pilot Active Crohn's Disease Study. * Subjects must continue to meet all inclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions: * CDAI score greater than 220 * Stool samples not required * C-reactive protein levels are not an exclusion criterion Exclusion Criteria: * Subject must continue to meet all exclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions: * Participation in a clinical study of an experimental drug or device within 30 days before signing consent.

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