Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease
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|ClinicalTrials.gov Identifier: NCT00620451|
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : September 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Celiac Disease||Drug: larazotide acetate Drug: placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized, parallel- group, double-blind, multicenter|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase IIb, Randomized, Double-Blind, Placebo Controlled Study for the Treatment of Active Celiac Disease With Larazotide Acetate (AT-1001)|
|Actual Study Start Date :||February 2008|
|Primary Completion Date :||July 2009|
|Study Completion Date :||December 2009|
Experimental: Larazotide acetate 4 mg
larazotide acetate capsules 4 mg TID
Drug: larazotide acetate
Experimental: Larazotide acetate 8 mg
Larazotide acetate capsules 8 mg TID
Drug: larazotide acetate
Placebo Comparator: Placebo
- Assess the efficacy of larazotide acetate in inducing remission in subjects with active celiac disease [ Time Frame: duodeno-jejunal biopsies were performed at Baseline and Day 56 ]Remission was defined as an improvement in the Villous Height to Crypt Depth (Vh:Cd) ratio obtained by duodeno-jejunal biopsy.
- Assess the safety and tolerability of larazotide acetate [ Time Frame: Up to 8 weeks ]Safety endpoints assessed in this study were adverse events, vital signs, physical examination results, clinical laboratory test results and ECG results. Plasma larazotide acetate and metabolites, as well as potential serum antibodies against larazotide acetate, were also determined.
- To prospectively validate the components of a composite weighted index of Celiac Disease activity (Celiac Disease Activity Rating Score, CeDARS), individually and as a whole. [ Time Frame: Up to 8 weeks ]Candidate components of the CeDARS Index measured in this study were GSRS, anti-tTG antibodies, LAMA ratio, Hb, ferritin, body weight, triceps skin fold thickness, BMI, urinary nitrates
- To compare the CeDARS against the Clinician Global Assessment of disease (CGA), Psychological Well Being Index (PWBI) and the Short Form 12 version 2 (SF-12v2) health survey. [ Time Frame: CGA, PWBI and SF-12v2 were collected at Visits 2, 3 and 4. ]The CGA was completed by the PI or designee; the PWBI and SF-12v2 were completed by the subject.
- To assess the effects of larazotide acetate on inflammatory markers in subjects with active celiac disease subjects [ Time Frame: Blood draws occurred at Visits 1, 2, 3, 4 and 5. ]Blood for serum was drawn for potential future determination of inflammatory mediators that might be involved in the response of Celiac Disease to larazotide acetate, such as cytokines (e.g. TNF-α,IFN-γ) or the putative permeability factor "zonulin".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00620451
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|Study Director:||Francisco Leon, MD, Ph.D||Alba Therapeutics|