Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hepatic Encephalopathy

In brief

The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul® in subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).

Key facts

Study ID

NCT00597909

Run by

Amgen

People needed

1

Starts

2007-12-01

Expected to finish

2008-09-01

Last updated by the study team

2024-12-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female between the ages of 18 and 75 years
• Signed written informed consent by subject's representative
• Current diagnosis of chronic liver disease with cirrhosis
• West Haven score of Grade 3 or 4 Hepatic Encephalopathy
• Weight between 45 and 150 kg
• Elevated venous ammonia concentration, defined as a value above the normal range at the local laboratory
• Estimated creatinine clearance of > 30 mL/min/1.73m², calculated using the Cockcroft-Gault formula, or serum creatinine < 2.5 mg/dL [Cockcroft-Gault formula: creatinine clearance = (140 - age) x weight in kg divided by (72 x serum creatinine in mg/dL); multiply result by 0.85 for females]
• Adequate urinary output of ≥ 30 mL/hour for the last 2 hours if estimated creatinine clearance is < 50 mL/min/1.73 m²
• Negative pregnancy test or documented sterilization procedure (tubal ligation or hysterectomy) or 5 years post-menopausal

You may not qualify if…

• Major gastrointestinal bleeding (hematemesis, melena, or hematochezia) requiring blood transfusion within the last 24 hours
• Uncontrolled sepsis, as defined by hemodynamic instability requiring vasopressor agents (renal-dosed dopamine allowed)
• Current diagnosis of acute hepatic failure
• Alcohol ingestion during last 24 hours
• Post liver transplant
• Serum sodium < 120 mEq/L
• Serum potassium ≤ 3.5 mEq/L
• Use of probenecid, valproate, penicillin or its derivatives, or corticosteroids (oral or IV) within the last 24 hours
• Use of any sedatives, benzodiazepines, or any neuro- or psycho-active drugs in the last 6 hours and a positive urinary drug screen
• Subjects who received any mind-altering agents (such as barbiturates, propofol, opioids, or benzodiazepines) to assist with intubation are not eligible while the effects of the drug are still apparent
• Congestive heart failure (New York Heart Association Class III or IV)
• Seizures, dementia, or any neurologic or psychiatric condition within the last 72 hours that may interfere with the assessment of the mental state
• Current diagnosis of major aspiration pneumonia or pulmonary edema accompanied by an oxygen saturation of ≤ 90% while breathing supplemental oxygen
• Laboratory test abnormalities determined to be clinically significant by the investigator
• Enrollment in another experimental (interventional) protocol within the last 30 days or 5 half-lives of the experimental drug, whichever s longer
• Any medical condition, which in the opinion of the investigator would constitute a contraindication to enrollment in the study

Where it is running

• UCSF-Fresno University — Fresno, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Permian Research Foundation — Odessa, Texas, United States

Full record on ClinicalTrials.gov

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