Study of the Efficacy of AT1001 (Larazotide Acetate) to Treat Celiac Disease
This study has been completed.
Sponsor:
Alba Therapeutics
Information provided by (Responsible Party):
Alba Therapeutics
ClinicalTrials.gov Identifier:
NCT00889473
First received: April 27, 2009
Last updated: July 12, 2012
Last verified: January 2010
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Purpose
This study will look at one dose of AT1001 for efficacy and safety for the treatment of celiac disease.
The primary efficacy outcome is the rate of response to gluten.
| Condition | Intervention | Phase |
|---|---|---|
|
Celiac Disease |
Drug: Larazotide acetate (AT1001) Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase IIb, Randomized, Double-blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of AT-1001 in Celiac Disease Subjects During a Gluten Challenge |
Resource links provided by NLM:
Genetics Home Reference related topics:
celiac disease
MedlinePlus related topics:
Celiac Disease
U.S. FDA Resources
Further study details as provided by Alba Therapeutics:
Primary Outcome Measures:
- Response to gluten [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Anti-transglutaminase [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 42 |
| Study Start Date: | April 2009 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AT1001 Active |
Drug: Larazotide acetate (AT1001)
One capsule TID given with gluten or gluten placebo
|
| Placebo Comparator: Placebo |
Drug: Placebo
One capsule TID given with gluten or gluten placebo
|
Detailed Description:
This is an outpatient, randomized, double-blind multicenter study. Subjects will remain on their gluten-free diet throughout the duration of the trial. Study drug or drug placebo capsules will be administered TID 15 minutes before each meal (breakfast, lunch, and dinner). Gluten or gluten placebo capsules will be taken TID with each meal.
Eligibility| Ages Eligible for Study: | 18 Years to 72 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age between 18 and 72 years, inclusive
- Diagnosed with Celiac Disease for more than 12 months
- Anti-tissue Transglutaminase (anti-tTG) less than 10 EU
- On a gluten-free diet for at least 12 months
- BMI between 18.5 and 38, inclusive
Exclusion Criteria:
- Current smoker
- Has chronic active GI disease other than Celiac Disease (e.g., Crohn's, colitis)
- Has diabetes (Type 1 or Type 2)
- Participated in any clinical drug study within the past 30 days or has had previous exposure to AT-1001
- Presents with or has a history of dermatitis herpetiformis
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889473
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889473
Locations
| United States, California | |
| Study Site | |
| Orange, California, United States | |
| United States, Kansas | |
| Study Site | |
| Topeka, Kansas, United States | |
| United States, Kentucky | |
| Study Site | |
| Lexington, Kentucky, United States | |
| United States, Maryland | |
| Study Site | |
| Hagerstown, Maryland, United States | |
| Study Site | |
| Silver Spring, Maryland, United States | |
| United States, Michigan | |
| Study Site | |
| Chesterfield, Michigan, United States | |
| Study Site | |
| Troy, Michigan, United States | |
| United States, Minnesota | |
| Study Site | |
| Rochester, Minnesota, United States | |
| United States, New York | |
| Study Site | |
| New York, New York, United States | |
| United States, Oklahoma | |
| Study Site | |
| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
| Study Site | |
| Paoli, Pennsylvania, United States | |
| Study Site | |
| Philadelphia, Pennsylvania, United States | |
| Study Site | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Tennessee | |
| Study Site | |
| Franklin, Tennessee, United States | |
| Canada, Alberta | |
| Study Site | |
| Edmonton, Alberta, Canada | |
Sponsors and Collaborators
Alba Therapeutics
Investigators
| Study Director: | Francisco Leon, MD, PhD | Alba Therapeutics Inc |
More Information
| Responsible Party: | Alba Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00889473 History of Changes |
| Other Study ID Numbers: | CLIN1001-006 Part B |
| Study First Received: | April 27, 2009 |
| Last Updated: | July 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Alba Therapeutics:
|
Celiac Disease Gluten |
Additional relevant MeSH terms:
|
Celiac Disease Malabsorption Syndromes Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases |
ClinicalTrials.gov processed this record on September 29, 2016