Trial Outcomes & Findings for Tolvaptan to Reduce Length of Stay in Hospitalized Patients With Cirrhosis and Hyponatremia (NCT NCT01890694)

NCT ID: NCT01890694

Last Updated: 2017-12-11

Results Overview

Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 2 participants
• Primary outcome timeframe: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
• Results posted on: 2017-12-11

Participant Flow

Participant milestones

Measure	Placebo Subjects will receive placebo once daily.	Tolvaptan Subjects will receive 15 mg Tolvaptan once daily.
Overall Study STARTED	1	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tolvaptan to Reduce Length of Stay in Hospitalized Patients With Cirrhosis and Hyponatremia

Baseline characteristics by cohort

Measure	Total n=2 Participants Total of all reporting groups	Placebo n=1 Participants Subjects will receive placebo once daily.	Tolvaptan n=1 Participants Subjects will receive 15 mg Tolvaptan once daily.
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=5 Participants	1 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=5 Participants	1 Participants n=7 Participants

PRIMARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Population: Data were not collected due to premature termination of the trial

Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 2

Population: Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.

Change from baseline of Hepatic Encephalopathy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 4

Population: Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.

Change from baseline of Hepatic Encephalopathy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 6

Population: Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.

Change from baseline of Hepatic Encephalopathy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 8

Population: Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.

Change from baseline of Hepatic Encephalopathy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Population: Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.

Change from baseline of Hepatic Encephalopathy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 1-4 Post-discharge

Population: Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.

Change from baseline of Hepatic Encephalopathy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Months 2-6 post-discharge

Population: Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.

Change from baseline of Hepatic Encephalopathy

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 to Post-discharge (6 months)

Population: Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.

Improved control of ascites

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 to Post-discharge (6 months)

Population: Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.

Improved renal function from baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post-Discharge (6 months)

Population: Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.

Lower readmission rate

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Post-discharge (6 months)

Population: Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.

Improved chances of survival when receiving Tolvaptan vs. standard of care

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 to Post-discharge (6 months)

Population: Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.

Improved neutrophil function from baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 until Discharge (participants will be followed for the duration of hospital stay, an expected average of 2 weeks)

Population: Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.

Improved ability to tolerate diuretic therapy, as evidenced by reduced adverse events to diuretic therapy and reduced risk of re-hospitalization.

Outcome measures

Outcome data not reported

Adverse Events

Tolvaptan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Office of Clinical Trials

NYU Langone Medical Center

Phone: 646-754-7431

Email: clinicaltrials@nyumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place