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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Teduglutide (ALX-0600)
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn Disease, Crohn's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Advanced Clinical Therapeutics
  • Rocky Mountain Gastroenterology
  • Rx Trials
  • Clinical Trials Management of Boca Raton
  • Clinical Research of West Florida
  • Venture Research
  • Pinnacle Trials
  • Saint Joseph's Health System
  • Northwestern University School of Medicine
  • University of Chicago
  • University of Louisville
  • Long Island Clinical Research Associates
  • Asher Kornbluth, MD, PC
  • Wake Research Associates
  • Cleveland Clinic Foundation
  • Lynn Health Science Institute
  • Atilla Ertan
  • University of Utah
  • McGuire DVAMC
  • Dean Foundation Research Center
  • Vancouver General Hospital
  • Health Sciences Center
  • Queen Elizabeth II Health Sciences
  • Life Screening Centres

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
May 12, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT00308438
Brief Title
Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2004 (Actual)
Primary Completion Date
November 1, 2005 (Actual)
Study Completion Date
June 1, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn Disease, Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
All subjects in the study dosed at 0.1 mg/kg teduglutide
Intervention Type
Drug
Intervention Name(s)
Teduglutide (ALX-0600)
Other Intervention Name(s)
teduglutide
Intervention Description
0.1 mg/kg injected subcutaneously daily
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Clinical Therapeutics
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Rocky Mountain Gastroenterology
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Rx Trials
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Clinical Trials Management of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Venture Research
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Pinnacle Trials
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Saint Joseph's Health System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northwestern University School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60619
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Long Island Clinical Research Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Asher Kornbluth, MD, PC
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Atilla Ertan
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
McGuire DVAMC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Dean Foundation Research Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L5
Country
Canada
Facility Name
Health Sciences Center
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Life Screening Centres
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2A5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19821509
Citation
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.
Results Reference
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Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008

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