NCT00308438

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2004

Geographic Reach
2 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

May 14, 2021

Status Verified

May 1, 2021

Enrollment Period

1.7 years

First QC Date

September 13, 2005

Last Update Submit

May 12, 2021

Conditions

Crohn's Disease

Keywords

Crohn DiseaseCrohn's Disease

Outcome Measures

Primary Outcomes (1)

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

    12 weeks after start of study

Secondary Outcomes (2)

  • 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.

    12 weeks after study start

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

    12 weeks after study start

Study Arms (1)

1

EXPERIMENTAL

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

Drug: Teduglutide (ALX-0600)

Interventions

Teduglutide (ALX-0600)DRUG

0.1 mg/kg injected subcutaneously daily

Also known as: teduglutide
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have completed participation in the Pilot Active Crohn's Disease Study.
  • CDAI score greater than 220
  • Stool samples not required

You may not qualify if:

  • Participation in a clinical study of an experimental drug or device within 30 days before signing consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Advanced Clinical Therapeutics

Tucson, Arizona, 85712, United States

Location

Rocky Mountain Gastroenterology

Lakewood, Colorado, 80401, United States

Location

Rx Trials

Washington D.C., District of Columbia, 20010, United States

Location

Clinical Trials Management of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

Venture Research

North Miami Beach, Florida, 33162, United States

Location

Pinnacle Trials

Atlanta, Georgia, 30329, United States

Location

Saint Joseph's Health System

Atlanta, Georgia, 30342, United States

Location

Northwestern University School of Medicine

Chicago, Illinois, 60619, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Long Island Clinical Research Associates

Great Neck, New York, 11021, United States

Location

Asher Kornbluth, MD, PC

New York, New York, 10128, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Atilla Ertan

Houston, Texas, 77005, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

McGuire DVAMC

Richmond, Virginia, 23249, United States

Location

Dean Foundation Research Center

Madison, Wisconsin, 53715, United States

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1L5, Canada

Location

Health Sciences Center

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Queen Elizabeth II Health Sciences

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Life Screening Centres

Toronto, Ontario, M5S 2A5, Canada

Location

Related Publications (1)

  • Buchman AL, Katz S, Fang JC, Bernstein CN, Abou-Assi SG; Teduglutide Study Group. Teduglutide, a novel mucosally active analog of glucagon-like peptide-2 (GLP-2) for the treatment of moderate to severe Crohn's disease. Inflamm Bowel Dis. 2010 Jun;16(6):962-73. doi: 10.1002/ibd.21117.

    PMID: 19821509BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Interventions

teduglutideALX-0600

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

September 13, 2005

First Posted

March 29, 2006

Study Start

March 1, 2004

Primary Completion

November 1, 2005

Study Completion

June 1, 2006

Last Updated

May 14, 2021

Record last verified: 2021-05

Locations

US(20)CA(4)