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AST-120 Used to Treat Mild Hepatic Encephalopathy (ASTUTE)

This study has been completed.
Sponsor:
Information provided by:
Ocera Therapeutics
ClinicalTrials.gov Identifier:
NCT00867698
First received: March 20, 2009
Last updated: June 22, 2010
Last verified: June 2010
History of Changes

March 20, 2009
June 22, 2010
March 2009
April 2010   (final data collection date for primary outcome measure)
Neurocognitive improvement, defined as the change in the global summary score of the RBANS at Week 8 compared to Baseline. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00867698 on ClinicalTrials.gov Archive Site
 
 
 
 
 
AST-120 Used to Treat Mild Hepatic Encephalopathy
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy, Safety and Tolerability of AST-120 (Spherical Carbon Adsorbent) for 8 Weeks in the Treatment of Mild Hepatic Encephalopathy

The purpose of this study is to determine whether AST-120 is safe and effective in the treatment of mild hepatic encephalopathy.
 
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Mild Hepatic Encephalopathy
Drug: AST-120
AST-120
Other Name: Spherical carbon adsorbent
  • Experimental: AST-120 (6g)
    2 grams TID
    Intervention: Drug: AST-120
  • Placebo Comparator: Placebo A
    2 grams TID
    Intervention: Drug: AST-120
  • Experimental: AST-120 (12g)
    4 grams TID
    Intervention: Drug: AST-120
  • Placebo Comparator: Placebo B
    4 grams TID
    Intervention: Drug: AST-120
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
148
June 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00867698
AST-MHE201
No
Jeff Bornstein, MD, Ocera Therapeutics
Ocera Therapeutics
 
Study Director: Jeff Bornstein, MD Ocera Therapeutics, Inc.
Ocera Therapeutics
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP