Trial record 7 of 7 for:
"alba therapeutics"
Safety and Tolerability Study of AT1001 in Celiac Disease Subjects
This study has been completed.
Sponsor:
Alba Therapeutics
Information provided by:
Alba Therapeutics
ClinicalTrials.gov Identifier:
NCT00362856
First received: August 8, 2006
Last updated: November 12, 2007
Last verified: February 2007
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
There are no therapeutic products on the market for celiac disease today. Current treatment is limited to gluten free foods and a gluten-free diet.
The main purpose of this study is to test how safe, efficacious and tolerable the study drug AT1001 is in subjects with diagnosed celiac disease.
A second purpose is to study how your body responds to the drug when you ingest gluten. This response is determined by testing your urine, and by capturing your daily and weekly gastrointestinal symptoms associated with celiac disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Celiac Disease |
Drug: AT1001 |
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 2a, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of AT-1001 in Celiac Disease Subjects During 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:
- To demonstrate the safety and tolerability of multiple, oral doses of AT-1001 in celiac disease subjects that maintain a gluten-free diet.
Secondary Outcome Measures:
- To evaluate the efficacy of multiple dose levels of AT-1001 in preventing intestinal permeability changes induced by gluten challenge
- to evaluate the effects of multiple dose levels of AT-1001 in preventing the induction of celiac disease signs and symptoms resulting from gluten challenge.
| Estimated Enrollment: | 79 |
| Study Start Date: | August 2006 |
| Study Completion Date: | March 2007 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must have been diagnosed with celiac disease by biopsy for ≥ 6 months (attending physician confirmation will be accepted in lieu of a biopsy report).
- Have a Anti-Tissue Transglutaminase (tTG) ≤ 10 EU as measured by serology.
- Must be on a gluten-free diet for at least the past 6 months.
Exclusion Criteria:
- Have any chronic active GI disease other than celiac disease (e.g., IBS, Crohn's, Colitis).
- Have diabetes (Type 1 or Type 2).
- Chronically consumes non-steroidal anti-inflammatory agents ("NSAIDs") or takes proton-pump inhibitors.
- Consuming oral corticosteroids or immune suppressants.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362856
Locations
| United States, Arizona | |
| Research Site | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, California | |
| San Diego, California, United States, 92123 | |
| United States, Massachusetts | |
| Research Site | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| Research Site | |
| Rochester, Minnesota, United States, 55905 | |
| United States, New Jersey | |
| Morristown, New Jersey, United States, 07960 | |
| United States, North Dakota | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Pennsylvania | |
| Research Site | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| United States, Virginia | |
| Research Site | |
| Richmond, Virginia, United States, 23298 | |
Sponsors and Collaborators
Alba Therapeutics
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00362856 History of Changes |
| Other Study ID Numbers: | CLIN1001-004 |
| Study First Received: | August 8, 2006 |
| Last Updated: | November 12, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Celiac Disease Malabsorption Syndromes Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013