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    Clinical Trial Results:
    Hemodynamic profile of terlipressin and octreotide in patients with cirrhosis and portal hypertension. A randomised, single blinded clinical trial. (INFUTER)

    Summary
    EudraCT number
    		 2019-004328-39
    Trial protocol
    		 ES  
    Global end of trial date
    15 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INFUTER
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04353193
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    FRCB-IDIBAPS (Fundació de Recerca Clínic Barcelona – Institut d’Investigacions Biomèdiques August Pi i Sunyer IDIBAPS)
    Sponsor organisation address
    Rosselló, 149, Barcelona, Spain,
    Public contact
    FCRB, Fundació Clínic per a la Recerca Biomèdica_FCRB, 34 9322754009838, jcgarcia@clinic.cat
    Scientific contact
    FCRB, Fundació Clínic per a la Recerca Biomèdica_FCRB, 34 9322754009838, jcgarcia@clinic.cat
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Jul 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Jul 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the reduction in HVPG caused by three different regimens at 30 minutes, 1 and 2 hours after its administration. Terlipressin at continuous infusion, terlipressin as a bolus, octreotide as a bolus followed by a continuous infusion.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki, ICH-GCP guidelines, and applicable EU and national regulations. Informed consent was obtained from all participants prior to any study procedure. Personal data were pseudonymized and handled in compliance with GDPR. Ethics Committee approval was obtained before trial initiation.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jul 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 38
    Worldwide total number of subjects
    38
    EEA total number of subjects
    38
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    38
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Screening included informed consent, medical history, physical exam, ECG, and blood tests. Inclusion required cirrhosis, HVPG ≥12 mmHg, and stable disease. Exclusion criteria included QT-prolonging drugs, recent bleeding or infection, and hepatic encephalopathy. Non-eligible subjects were replaced.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 TERLINF group
    Arm description
    		 Terlipressin by IV continuous infusion at a rate of 2mg/day (max 4mg/day) during 2 hours
    Arm type
    		 Experimental

    Investigational medicinal product name
    Terlipressin
    Investigational medicinal product code
    Other name
    Glypressin®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Infusion
    Dosage and administration details
    Terlipressin (Glypressin®) 0.2 mg/ml Terlipressin continuous infusion. After baseline measurements an infusion at an initial dose corresponding to 2mg/day will be started. lf HVPG at min 30 does not exhibit a reduction >10%, the rate of infusion will be increased up to the corresponding dose of 4mg/day dose and the following measurements at 1 and 2 hours will be performed.

    Arm title
    		 TERLBOL group
    Arm description
    		 Terlipressin 1mg IV bolus
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Terlipressin
    Investigational medicinal product code
    Other name
    Glypressin®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Terlipressin (Glypressin®) 0.2 mg/ml Terlipressin bolus. After baseline measurements, a single intravenous injection of terlipressin 1mg will be administered.

    Arm title
    		 OCTR group
    Arm description
    		 Octreotide 50mcg IV bolus plus continuous infusion at a rate of 50mcg/h during 2 hours
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Octreotide
    Investigational medicinal product code
    Other name
    Sandostatin®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous bolus use , Infusion
    Dosage and administration details
    Octreotide (Sandostatin®) 100 mcg/ml. Octreotide 50mcg IV bolus plus continuous infusion at a rate of 50mcg/h during 2 hours

    Number of subjects in period 1
    		TERLINF group TERLBOL group OCTR group
    Started
    14
    12
    12
    Completed
    14
    12
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TERLINF group
    Reporting group description
    		 Terlipressin by IV continuous infusion at a rate of 2mg/day (max 4mg/day) during 2 hours

    Reporting group title
    TERLBOL group
    Reporting group description
    		 Terlipressin 1mg IV bolus

    Reporting group title
    OCTR group
    Reporting group description
    		 Octreotide 50mcg IV bolus plus continuous infusion at a rate of 50mcg/h during 2 hours

    Reporting group values
    		 TERLINF group TERLBOL group OCTR group Total
    Number of subjects
    		 14 12 12 38
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.5 ( 11.9 ) 58.8 ( 7.5 ) 57.9 ( 8.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 7 4 1 12
        Male
    		 7 8 11 26

    End points

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    End points reporting groups
    Reporting group title
    TERLINF group
    Reporting group description
    		 Terlipressin by IV continuous infusion at a rate of 2mg/day (max 4mg/day) during 2 hours

    Reporting group title
    TERLBOL group
    Reporting group description
    		 Terlipressin 1mg IV bolus

    Reporting group title
    OCTR group
    Reporting group description
    		 Octreotide 50mcg IV bolus plus continuous infusion at a rate of 50mcg/h during 2 hours

    Primary: Change in hepatic venous pressure gradient (HVPG)

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    End point title
    		 Change in hepatic venous pressure gradient (HVPG)
    End point description
    Change in HVPG measured at 30, 60, and 120 minutes following administration of terlipressin (bolus or infusion) or octreotide (bolus + infusion) during hepatic vein catheterization.
    End point type
    Primary
    End point timeframe
    30 minutes, 1 hour, and 2 hours after administration of the investigational product
    End point values
    		 TERLINF group TERLBOL group OCTR group
    Number of subjects analysed
    14
    12
    12
    Units: mmHg
    arithmetic mean (standard deviation)
        Basal
    18.5 ( 1.4 )
    18.4 ( 1.5 )
    20.2 ( 1.5 )
        30 minutes
    18.6 ( 1.4 )
    17.5 ( 1.5 )
    19.2 ( 1.5 )
        1 hour
    18.2 ( 1.4 )
    17.7 ( 1.5 )
    19.2 ( 1.5 )
        2 hours
    18.3 ( 1.4 )
    17.5 ( 1.5 )
    19.2 ( 1.5 )
    Statistical analysis title
    		 HVPG change over time between treatment groups
    Statistical analysis description
    Evaluation of hepatic venous pressure gradient (HVPG) changes at baseline, 30 min, 60 min, and 120 min in three treatment groups (TERLINF, TERLBOL, OCTR) using a generalized multilevel mixed-effects model (GLMM) for repeated measures. The model included time × treatment interaction as fixed effects to assess differences in HVPG trajectories.
    Comparison groups
    TERLINF group v TERLBOL group v OCTR group
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.85 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -4.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.85
         upper limit
    		 -3.95
    Variability estimate
    Standard deviation
    Dispersion value
    1.5
    Notes
    [1] - Pre-specified superiority analysis comparing HVPG changes over 2 hours among TERLINF, TERLBOL, and OCTR groups using GLMM.
    [2] - No statistically significant difference in HVPG trajectories between treatment groups over time.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    During treatment administration (0–120 min), at 24 hours post-procedure, and at 7-day follow-up clinical visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28.0
    Reporting groups
    Reporting group title
    TERBOL group
    Reporting group description
    		 -

    Reporting group title
    OCTR group
    Reporting group description
    		 -

    Reporting group title
    TERLINF group
    Reporting group description
    		 -

    Serious adverse events
    		 TERBOL group OCTR group TERLINF group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 TERBOL group OCTR group TERLINF group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
    Cardiac disorders
    Desaturation
    Additional description: Desaturation during the measurement of cardiopulmonary parameters at the end of the procedure.
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 14 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Sep 2020
    SM-1. This amendment expands inclusion and exclusion criteria to improve recruitment. Patients with compensated cirrhosis (Child-Pugh A5/A6) are now eligible, in addition to B and C up to 12 points. The bilirubin threshold is increased to 10 mg/dL to allow inclusion of patients with acute alcoholic hepatitis and transient hyperbilirubinemia.
    17 Feb 2023
    SM-2

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Small sample size and short observation period may limit generalizability. HVPG changes were not statistically significant across groups.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/40190717
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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