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Completed

NCT Number: NCT00308438

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

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

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vancouver General Hospital, Vancouver, British Columbia, Canada

Loading trial locations.

About this study

The study is sixteen weeks in duration and there are twelve weeks of once-daily injections into your abdomen or thigh. There are a total of five visits.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Teduglutide (ALX-0600)

Drug

0.1 mg/kg injected subcutaneously daily

Other names: teduglutide

Primary outcomes

  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

  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

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

An Open Label Extension Study of the Safety and Efficacy of ALX-0600 in Subjects With Crohn's Disease Who Completed the Pilot Study Protocol CL0600-008

Important dates

Study start
2004
Primary completion
2005
Study completion
2006
First posted
Mar 29, 2006
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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