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| Sponsored by: |
Alba Therapeutics |
|---|---|
| Information provided by: | Alba Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00620451 |
Purpose
The purpose of this research study is to look at how effective and safe larazotide acetate (AT-1001) is when it is given to subjects who have active Celiac Disease. A "leaky gut" is often found in Celiac Disease patients, and it is thought that the leakiness contributes to the disease, possibly by letting more gluten enter the body. Larazotide acetate (AT-100l) is an experimental drug that may possibly reduce gut leakiness and is being investigated to see if it can help people with Celiac disease along with a gluten free diet.
| Condition | Intervention | Phase |
|---|---|---|
|
Celiac Disease |
Drug: larazotide acetate (AT-1001) Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase IIb, Randomized, Double-Blind, Placebo Controlled Study for the Treatment of Active Celiac Disease With AT-1001 |
| Estimated Enrollment: | 150 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: larazotide acetate (AT-1001)
4 mg three times a day for 8 weeks
|
| 2: Experimental |
Drug: larazotide acetate (AT-1001)
8 mg three times a day for 8 weeks
|
| 3: Placebo Comparator |
Drug: placebo
placebo three times a day for 8 weeks
|
This will be an outpatient, randomized, parallel-group, double-blind, multicenter, 8-week study with the following treatment arms:
Subjects will be required to have a baseline/screening biopsy and a follow-up biopsy at Day 56. Subjects will be required to adhere to a gluten free diet for the duration of the study.
Primary Outcome:
* To assess the efficacy of larazotide acetate (AT-1001) versus placebo in inducing remission in subjects with active Celiac Disease. Improvement is defined by changes (Villous Height to Crypt Depth (Vh:Cd) ratio),measured by duodenal-jejunal biopsy.
Secondary Outcome:
*To assess safety and tolerability of larazotide acetate (AT-1001) in subjects with active Celiac Disease.
Estimated Enrollment 150 subjects Estimated Study Start Date: February 2008 Estimated Study Completion Date: December 2008
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Francisco Leon, MD, Ph.D | 1-877-415-3282 | clintrials@albatherapeutics.com |
| Contact: Kate Huber, MBA | 1-877-415-3282 | clintrials@albatherapeutics.com |
Show 34 Study Locations| Study Director: | Francisco Leon, MD, Ph.D | Alba Therapeutics |
More Information
| Responsible Party: | Alba Therapeutics ( Francisco Leon, MD, Ph.D/Study Director ) |
| Study ID Numbers: | AT1001-011 |
| Study First Received: | February 7, 2008 |
| Last Updated: | January 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00620451 |
| Health Authority: | United States: Food and Drug Administration |
|
Treatment Active Celiac Remission Induction |
|
Metabolic Diseases Digestive System Diseases Gastrointestinal Diseases Malabsorption Syndromes |
Celiac Disease Metabolic disorder Intestinal Diseases |
