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 2, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Mild Hepatic Encephalopathy
Drug: AST-120
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 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

Resource links provided by NLM:


Further study details as provided by Ocera Therapeutics:

Primary Outcome Measures:
  • 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 ]

Enrollment: 148
Study Start Date: March 2009
Study Completion Date: June 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AST-120 (6g)
2 grams TID
Drug: AST-120
AST-120
Other Name: Spherical carbon adsorbent
Placebo Comparator: Placebo A
2 grams TID
Drug: AST-120
AST-120
Other Name: Spherical carbon adsorbent
Experimental: AST-120 (12g)
4 grams TID
Drug: AST-120
AST-120
Other Name: Spherical carbon adsorbent
Placebo Comparator: Placebo B
4 grams TID
Drug: AST-120
AST-120
Other Name: Spherical carbon adsorbent

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00867698

  Show 38 Study Locations
Sponsors and Collaborators
Ocera Therapeutics
Investigators
Study Director: Jeff Bornstein, MD Ocera Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Jeff Bornstein, MD, Ocera Therapeutics
ClinicalTrials.gov Identifier: NCT00867698     History of Changes
Other Study ID Numbers: AST-MHE201
Study First Received: March 20, 2009
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ocera Therapeutics:
Hepatic encephalopathy
Mild hepatic encephalopathy
HE
MHE
Cognitive impairment
Cognitive dysfunction
Liver Disease
Cirrhosis

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Brain Diseases, Metabolic
Central Nervous System Diseases
Digestive System Diseases
Hepatic Insufficiency
Liver Diseases
Liver Failure
Metabolic Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 29, 2014