AST-120 Used to Treat Mild Hepatic Encephalopathy

(ASTUTE Trial)

Recruiting in Palo Alto (17 mi)

+37 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Ocera Therapeutics

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Jeff Bornstein, MD

Principal Investigator

Ocera Therapeutics, Inc.

Eligibility Criteria

Inclusion Criteria

Confirmed cirrhosis of any cause

Abnormal RBANS global summary score

Grade 0 or 1 hepatic encephalopathy by West-Haven Scale

Treatment Details

Interventions

• AST-120 (Adsorbent)

Participant Groups

Group I: AST-120 (6g) Experimental Treatment 1 Intervention

2 grams TID

Group II: AST-120 (12g) Experimental Treatment 1 Intervention

4 grams TID

Group III: Placebo B Placebo Group 1 Intervention

4 grams TID

Group IV: Placebo A Placebo Group 1 Intervention

2 grams TID

Who Is Running the Clinical Trial?

Ocera Therapeutics

Lead Sponsor

Trials

9

Recruited

590+