Trial Outcomes & Findings for Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding (NCT NCT00966355)

NCT ID: NCT00966355

Last Updated: 2018-03-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 1034 participants
• Primary outcome timeframe: 5 days after enrollment
• Results posted on: 2018-03-19

Participant Flow

Patients with liver cirrhosis presenting with either hematemesis or melena between October 1, 2006 and May 31, 2010 at eleven medical centers distributed throughout Korea.

failure to fulfill inclusion criteria, no cirrhosis, prior endoscopic therapy within 2 weeks, enrolled within 6 weeks before index bleed, severe cardiovascular diseases, chronic renal failure, hepatocellular carcinoma invading portal vein, other malignancy, pregnancy, HIV-positive, hypersensitivity to the study drugs, or refusal to participate.

Participant milestones

Measure	Octreotide treat with octreotide IV for 5 days and endoscopic treatment Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days	Somatostatin treat with somatostatin IV for 5 days and endoscopic treatment Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days	Terlipressin treat with terlipressin IV for 5 days and endoscopic treatment Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days
Overall Study STARTED	344	345	345
Overall Study COMPLETED	260	259	261
Overall Study NOT COMPLETED	84	86	84

Reasons for withdrawal

Measure	Octreotide treat with octreotide IV for 5 days and endoscopic treatment Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days	Somatostatin treat with somatostatin IV for 5 days and endoscopic treatment Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days	Terlipressin treat with terlipressin IV for 5 days and endoscopic treatment Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days
Overall Study non-variceal bleeding on endoscopy	68	70	71
Overall Study newly diagnosed advanced HCC	11	12	10
Overall Study Lost to Follow-up	5	4	3

Baseline Characteristics

Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding

Baseline characteristics by cohort

Measure	Octreotide n=260 Participants treat with octreotide IV for 5 days and endoscopic treatment Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days	Somatostatin n=259 Participants treat with somatostatin IV for 5 days and endoscopic treatment Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days	Terlipressin n=261 Participants treat with terlipressin IV for 5 days and endoscopic treatment Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days	Total n=780 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	220 Participants n=5 Participants	218 Participants n=7 Participants	223 Participants n=5 Participants	661 Participants n=4 Participants
Age, Categorical >=65 years	40 Participants n=5 Participants	41 Participants n=7 Participants	38 Participants n=5 Participants	119 Participants n=4 Participants
Age, Continuous	53.8 years STANDARD_DEVIATION 10.0 • n=5 Participants	53.1 years STANDARD_DEVIATION 9.7 • n=7 Participants	52.9 years STANDARD_DEVIATION 9.2 • n=5 Participants	53.3 years STANDARD_DEVIATION 9.6 • n=4 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	43 Participants n=7 Participants	38 Participants n=5 Participants	114 Participants n=4 Participants
Sex: Female, Male Male	227 Participants n=5 Participants	216 Participants n=7 Participants	223 Participants n=5 Participants	666 Participants n=4 Participants
Region of Enrollment Korea, Republic of	260 participants n=5 Participants	259 participants n=7 Participants	261 participants n=5 Participants	780 participants n=4 Participants

PRIMARY outcome

Timeframe: 5 days after enrollment

Outcome measures

Measure	Octreotide n=260 Participants treat with octreotide IV for 5 days and endoscopic treatment Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days	Somatostatin n=259 Participants treat with somatostatin IV for 5 days and endoscopic treatment Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days	Terlipressin n=261 Participants treat with terlipressin IV for 5 days and endoscopic treatment Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days
5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death)	218 participants	216 participants	225 participants

SECONDARY outcome

Timeframe: 5 days after enrollment

at least one of the three criteria

Outcome measures

Measure	Octreotide n=260 Participants treat with octreotide IV for 5 days and endoscopic treatment Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days	Somatostatin n=259 Participants treat with somatostatin IV for 5 days and endoscopic treatment Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days	Terlipressin n=261 Participants treat with terlipressin IV for 5 days and endoscopic treatment Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days
Active Bleeding During the First Endoscopic Exam, Needing Blood Transfusion for 5 Days, Experiencing Adverse Effects	113 participants	115 participants	114 participants

Adverse Events

Octreotide

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Somatostatin

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Terlipressin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Octreotide n=260 participants at risk treat with octreotide IV for 5 days and endoscopic treatment Octreotide : loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days	Somatostatin n=259 participants at risk treat with somatostatin IV for 5 days and endoscopic treatment Somatostatin : loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days	Terlipressin n=261 participants at risk treat with terlipressin IV for 5 days and endoscopic treatment Terlipressin : loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days
Gastrointestinal disorders diarrhea	1.2% 3/260 • Number of events 3	1.2% 3/259 • Number of events 3	1.5% 4/261 • Number of events 4

Additional Information

Prof. Soon Ho Um

Korea University College of Medicine

Phone: +82-2-920-5019

Email: umsh@korea.ac.kr

Results disclosure agreements

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