Trial record 2 of 3 for:    larazotide

Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate (AT-1001) in Active Celiac Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alba Therapeutics
ClinicalTrials.gov Identifier:
NCT00620451
First received: February 7, 2008
Last updated: July 12, 2012
Last verified: January 2010
  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 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 Study for the Treatment of Active Celiac Disease With AT-1001

Resource links provided by NLM:


Further study details as provided by Alba Therapeutics:

Primary Outcome Measures:
  • Villous Height to Crypt Depth (Vh:Cd) ratio [ Time Frame: Baseline and at Day 56 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of larazotide acetate (AT-1001) [ Time Frame: From Randomization to Follow-up ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: larazotide acetate (AT-1001)
4 mg three times a day for 8 weeks
Experimental: 2 Drug: larazotide acetate (AT-1001)
8 mg three times a day for 8 weeks
Placebo Comparator: 3 Drug: placebo
placebo three times a day for 8 weeks

Detailed Description:

This will be an outpatient, randomized, parallel-group, double-blind, multicenter, 8-week study with the following treatment arms:

  1. larazotide acetate (AT-1001) 4 mg (three times a day)
  2. larazotide acetate (AT-1001) 8 mg (three times a day)
  3. placebo (three times a day)

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 106 subjects Estimated Study Start Date: February 2008 Estimated Study Completion Date: December 2009

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age is 18 to 75 years, inclusive
  • Female subjects should be post-menopausal, surgically sterile or women of child bearing potential with a negative serum beta hCG pregnancy test
  • Is diagnosed with Celiac Disease by duodenal/jejunal biopsy or by capsule endoscopy plus positive anti-tTG
  • Is willing to comply with a gluten-free diet for the duration of the study

Exclusion Criteria:

  • Has Refractory Celiac Disease or sever complications of Celiac Disease (e.g. Enteropathy-associated T cell Lymphoma - EATL-, ulcerative jejunitis, perforation)
  • Is suspected to have lymphoma or any other serious complication of Celiac Disease
  • Has chronic active GI disease other than Celiac Disease
  • Has diabetes (Type 1 or Type 2) or other autoimmune disease that might interfere with the conduct of the study
  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: NCT00620451

  Hide Study Locations
Locations
United States, California
Study Site
Orange, California, United States, 92868
Study Site
San Francisco, California, United States, 94115
United States, Connecticut
Study Site
Torrington, Connecticut, United States, 06790
United States, Florida
Study Site
Jacksonville, Florida, United States, 32207
United States, Kansas
Study Site
Topeka, Kansas, United States, 66606
United States, Kentucky
Study Site
Lexington, Kentucky, United States, 40536
United States, Maryland
Study Site
Hagerstown, Maryland, United States, 21740
Study Site
Silver Spring, Maryland, United States, 20901
United States, Michigan
Study Site
Chesterfield, Michigan, United States, 48047
Study Site
Troy, Michigan, United States, 48084
United States, Minnesota
Study Site
Rochester, Minnesota, United States, 55905
United States, North Carolina
Study Site
Asheville, North Carolina, United States, 28801
Study Site
Harrisburg, North Carolina, United States, 28075
United States, Ohio
Study Site
Gallipolis, Ohio, United States, 45631
United States, Pennsylvania
Study Site
Paoli, Pennsylvania, United States, 19301
Study Site
Philadelphia, Pennsylvania, United States, 19014
Study Site
Pittsburg, Pennsylvania, United States, 15243
United States, South Dakota
Study Site
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Study Site
Franklin, Tennessee, United States, 37067
United States, Texas
Study Site
Houston, Texas, United States, 77030
Canada, Alberta
Study Site
Edmonton, Alberta, Canada, T6G2X8
Canada, British Columbia
Study Site
Abbotsford, British Columbia, Canada, V5ZIH2
Study Site
Kelowna, British Columbia, Canada, V1Y2H4
Canada, Ontario
Study Site
Richmond Hill, Ontario, Canada, L4B3PB
Spain
Study Site
Barcelona, Spain, 08028
Study Site
Huesca, Spain, 22004
Study Site
Leon, Spain, 24005
Study Site
Madrid, Spain, 28034
Study site
Madrid, Spain, 28040
Study Site
Madrid, Spain, 28007
Study Site
Palma de Mallorca, Spain, 07014
Study Site
Reus, Spain, 43201
Study Site
Valladolid, Spain, 47005
Sponsors and Collaborators
Alba Therapeutics
Investigators
Study Director: Francisco Leon, MD, Ph.D Alba Therapeutics
  More Information

Additional Information:
Publications:
Responsible Party: Alba Therapeutics
ClinicalTrials.gov Identifier: NCT00620451     History of Changes
Other Study ID Numbers: AT1001-011
Study First Received: February 7, 2008
Last Updated: July 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alba Therapeutics:
Treatment
Active
Celiac
Remission
Induction

Additional relevant MeSH terms:
Celiac Disease
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014