Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000903583p
Ethics application status
Not yet submitted
Date submitted
21/06/2024
Date registered
24/07/2024
Date last updated
24/07/2024
Date data sharing statement initially provided
24/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Outpatient terlipressin infusion for the prevention of liver events in cirrhosis
Scientific title
OutPatient continuous Terlipressin Infusion vs huMAn aLbumin for the prevention of decompensation events in adults with cirrhosis - an open label, multi-centre randomised controlled trial
Secondary ID [1] 312383 0
none
Universal Trial Number (UTN)
Trial acronym
OPTIMAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cirrhosis 334188 0
Condition category
Condition code
Oral and Gastrointestinal 330846 330846 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Continuous terlipressin infusion for 24 weeks
-3.4mg of terlipressin in 50ml of 10% dextrose over 24 hours delivered in a Surefuser pump via PICC line. This infusion will be changed on a daily basis by hospital in the home nursing staff. Medical reviews will occur weekly for the first 4 weeks then monthly thereafter.

Given all interventions will be administered by nursing staff we will have full knowledge of adherence throughout the study via HITH visits and records
Intervention code [1] 328885 0
Treatment: Drugs
Comparator / control treatment
Weekly intravenous albumin infusion of 200mL of 20% concentrated albumin for 24 weeks
-this will be administered through a PICC line, similar to the intervention arm, but on a weekly basis as per each institutions local practice (usually in local infusion centre) - this will be administered by infusion centre nurses.

Intervention administered by nursing staff - session attendance will be recorded prospectively
Control group
Active

Outcomes
Primary outcome [1] 338614 0
Time to major decompensating liver event
Timepoint [1] 338614 0
Time to first decompensating liver event within the 24 week study period will be recorded
Secondary outcome [1] 436663 0
Health care costs
Timepoint [1] 436663 0
All data on hospitalisations will be prospectively collated by site nursing coordinators over the 24 weeks. Economic analysis will occur at end of study
Secondary outcome [2] 436664 0
Total hospitalisation days, cause for hospitalisation (liver events vs non-liver events)
Timepoint [2] 436664 0
All data on hospitalisations will be prospectively collated by site nursing coordinators over the 24 weeks.
Secondary outcome [3] 436666 0
Quality of life
Timepoint [3] 436666 0
-baseline
-week 4 post-baseline
-week 8 post-baseline
-week 12 post-baseline
-week 24 post-baseline
Secondary outcome [4] 436941 0
Muscle strength
Timepoint [4] 436941 0
baseline
week 4 post-baseline
week 8 post-baseline
week 12 post-baseline
week 24 post-baseline
Secondary outcome [5] 436942 0
Muscle function
Timepoint [5] 436942 0
baseline
week 4 post-baseline
week 8 post-baseline
week 12 post-baseline
week 24 post-baseline
Secondary outcome [6] 436943 0
Nutrition assessment
Timepoint [6] 436943 0
Baseline
week 4 post-baseline
week 8 post-baseline
week 12 post-baseline
week 24 post-baseline
Secondary outcome [7] 437614 0
Minimal hepatic encephalopathy
Timepoint [7] 437614 0
Baseline
Week 4 post-baseline
Week 8 post-baseline
Week 12 post-baseline
Week 16 post-baseline
Week 20 post-baseline
Week 24 post-baseline

Eligibility
Key inclusion criteria
Cirrhosis with ascites
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Alcohol intake within 6 months
NHYA heart failure class III or IV
intrinsic renal disease eGFR <30
active cancer other than HCC within Milan
Terlipressin intolerance

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Powered to assess for a 30% absolute reduction in incidence of hospitalisation for decompensating liver events (estimating 30% in terlipressin arm and 60% in albumin arm)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
1/06/2027
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 316792 0
Self funded/Unfunded
Name [1] 316792 0
Country [1] 316792 0
Primary sponsor type
Hospital
Name
Austin Health
Address
Country
Australia
Secondary sponsor category [1] 319013 0
None
Name [1] 319013 0
Address [1] 319013 0
Country [1] 319013 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315560 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 315560 0
Ethics committee country [1] 315560 0
Australia
Date submitted for ethics approval [1] 315560 0
01/10/2024
Approval date [1] 315560 0
Ethics approval number [1] 315560 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135078 0
A/Prof Marie Sinclair
Address 135078 0
Austin Health, 145 Studley Road, Heidelberg, VIC, Australia 3084
Country 135078 0
Australia
Phone 135078 0
+61394965353
Fax 135078 0
Email 135078 0
marie.sinclair@austin.org.au
Contact person for public queries
Name 135079 0
Marie Sinclair
Address 135079 0
Austin Health, 145 Studley Road, Heidelberg, VIC, Australia 3084
Country 135079 0
Australia
Phone 135079 0
+61394965353
Fax 135079 0
Email 135079 0
marie.sinclair@austin.org.au
Contact person for scientific queries
Name 135080 0
Marie Sinclair
Address 135080 0
Austin Health, 145 Studley Road, Heidelberg, VIC, Australia 3084
Country 135080 0
Australia
Phone 135080 0
+61394965353
Fax 135080 0
Email 135080 0
marie.sinclair@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.