Trial Outcomes & Findings for Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy (NCT NCT00597909)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Time to Grade 2 or less sustaining for 4 hours or longer

Results posted on

2024-12-17

Participant Flow

One participant was enrolled but did not receive drug or was randomized.

Participant milestones

Participant milestones
Measure	Arm 1 sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)	Arm 2 sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)	Arm 3 placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
Overall Study STARTED	0	0	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Time to Grade 2 or less sustaining for 4 hours or longer

Population: One participant enrolled but did not receive drug or was randomized.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 hours of treatment and follow-up

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 hours of treatment and follow-up

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 hours of treatment and follow-up

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 hours of treatment and follow-up

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 96 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 hours of treatment and follow-up

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 96 hours of treatment and follow-up

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 24 hours during treatment period of 96 hours

Outcome measures

Outcome data not reported

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bruce Scharschmidt, MD

Horizon Pharma plc

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER