AST-120 Used to Treat Mild Hepatic Encephalopathy

Phase 2

Completed

• Conditions: Mild Hepatic Encephalopathy
• Interventions: Drug: AST-120

• Registration Number: NCT00867698
• Lead Sponsor: Ocera Therapeutics

Brief Summary

The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-20
• Study First Submitted QC: 2009-03-20
• Study First Posted: 2009-03-24
• Primary Completion: 2010-04
• Study Completion: 2010-06
• Disposition First Submitted: 2013-07-26
• Status Verified: 2014-06
• Disposition First Submitted QC: 2014-06-02
• Last Update Submitted: 2014-06-02
• Disposition First Posted: 2014-06-18
• Last Update Posted: 2014-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

1. Confirmed cirrhosis of any cause
2. Abnormal RBANS global summary score
3. Grade 0 or 1 hepatic encephalopathy by West-Haven Scale
4. MELD score < or = 25
5. Females must be postmenopausal, surgically incapable of bearing children or practicing a reliable method of birth control

Exclusion Criteria

1. Previous participation in any trial involving AST-120
2. History of TIPS or surgically created portocaval shunt
3. Treatment for overt HE within the past 3 months
4. Use of lactulose, rifaximin, neomycin or other antibiotics in the past 7 days
5. Active alcohol abuse
6. Psychosis or organic brain syndromes due to alcohol or other causes
7. Use of interferon and sedating or cognition-altering drugs
8. Undergoing chemotherapy or radiotherapy for the treatment of cancer
9. Active GI bleeding within the past 3 months
10. Presence of an active infection
11. Presence of signs and symptoms of severe dehydration
12. Other major physical or major psychiatric illness within the past 6 months
13. Pregnant, breast feeding, or planning to become pregnant during the study
14. Using hormonal contraception as the only method of birth control

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AST-120 (6g)	AST-120	2 grams TID
Placebo A	AST-120	2 grams TID
AST-120 (12g)	AST-120	4 grams TID
Placebo B	AST-120	4 grams TID

Primary Outcome Measures

Name	Time	Method
Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline.	8 weeks

Trial Locations

Locations (37)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States

UCSF - Fresno Community Regional Medical Center; 🇺🇸 Fresno, California, United States

UCSD Medical Center; 🇺🇸 San Diego, California, United States

Scripps Clinic; 🇺🇸 San Diego, California, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

University of Florida College of Medicine; 🇺🇸 Gainesville, Florida, United States

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

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