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

Phase 2
Waitlist Available
Research Sponsored by Ocera Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved

Summary

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

Eligible Conditions
  • Liver Brain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2011 Phase 3 trial • 1020 Patients • NCT00500682
11%
Oedema peripheral
11%
Hypertension
11%
Anaemia
9%
Nausea
9%
Renal failure chronic
8%
Constipation
7%
Hyperkalaemia
7%
Urinary tract infection
6%
Diarrhoea
5%
Gout
5%
Bronchitis
5%
Vomiting
5%
Upper respiratory tract infection
4%
Arthralgia
4%
Back pain
4%
Metabolic acidosis
4%
Headache
4%
Hyperphosphataemia
4%
Influenza
4%
Nasopharyngitis
4%
Cough
4%
Arteriovenous fistula operation
4%
Dyspnoea
3%
Muscle spasms
3%
Hyperglycaemia
3%
Pneumonia
3%
Oedema
3%
Pruritus
3%
Cataract
3%
Abdominal distension
3%
Asthenia
3%
Gastroenteritis
3%
Respiratory tract infection
3%
Pain in extremity
3%
Fatigue
3%
Abdominal pain upper
2%
Hyperparathyroidism
2%
Hypoglycaemia
2%
Decreased appetite
2%
Abdominal pain
2%
Hyperparathyroidism secondary
2%
Dyspepsia
2%
Vitamin D deficiency
2%
Renal impairment
2%
Dizziness
2%
Renal failure acute
2%
Angina pectoris
2%
Osteoarthritis
2%
Hypotension
2%
Hyperlipidaemia
2%
Cardiac failure congestive
2%
Pharyngitis
2%
Blood creatine phosphokinase increased
2%
Dyslipidaemia
2%
Hypercalcaemia
2%
Insomnia
1%
Acidosis
1%
Flatulence
1%
Blood creatinine increased
1%
Hypertensive crisis
1%
Pyrexia
1%
Bradycardia
1%
Epistaxis
1%
Rash
1%
Acute myocardial infarction
1%
Cardiac failure
1%
Myocardial infarction
1%
Gastritis
1%
Musculoskeletal pain
1%
Renal failure
1%
Hypocalcaemia
1%
Hypercholesterolaemia
1%
Hyperuricaemia
1%
Iron deficiency anaemia
1%
Depression
1%
Coronary artery disease
1%
Cellulitis
1%
Cerebrovascular accident
1%
Erysipelas
1%
Herpes zoster
1%
Pyelonephritis chronic
1%
Rhinitis
1%
Ligament sprain
1%
Vitamin D decreased
1%
Dehydration
1%
Fluid overload
1%
Azotaemia
1%
Sinusitis
1%
Myalgia
1%
Acute coronary syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
AST-120

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: AST-120 (6g)Experimental Treatment1 Intervention
2 grams TID
Group II: AST-120 (12g)Experimental Treatment1 Intervention
4 grams TID
Group III: Placebo BPlacebo Group1 Intervention
4 grams TID
Group IV: Placebo APlacebo Group1 Intervention
2 grams TID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Activated charcoal
FDA approved

Find a Location

Who is running the clinical trial?

Ocera TherapeuticsLead Sponsor
8 Previous Clinical Trials
440 Total Patients Enrolled
Jeff Bornstein, MDStudy DirectorOcera Therapeutics, Inc.
4 Previous Clinical Trials
78 Total Patients Enrolled
~9 spots leftby Jan 2026
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