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    Clinical Trial Results:
    A Phase III, Open Label, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intrapleural Administration of Adenovirus-Delivered Interferon Alpha-2b (rAd-IFN) in Combination with Celecoxib and Gemcitabine in Patients with Malignant Pleural Mesothelioma

    Summary
    EudraCT number
    2017-003169-82
    Trial protocol
    GB   DE   FR   PL   IT  
    Global end of trial date
    16 Jan 2026

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Mar 2026
    First version publication date
    14 Mar 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    rAd-IFN-MM-301
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03710876
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Ferring Ventures Ltd.
    Sponsor organisation address
    Drayton Hall, Church Road, West Drayton, United Kingdom, UB7 7PS
    Public contact
    Lindsay Caygill, Ferring Ventures Ltd., lindsay.caygill@trizell.com
    Scientific contact
    Lindsay Caygill, Ferring Ventures Ltd., lindsay.caygill@trizell.com
    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
    07 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 May 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jan 2026
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to compare the overall survival associated with rAd-IFN, when administered with celecoxib and gemcitabine, versus that associated with celecoxib and gemcitabine alone for the treatment of patients with MPM who have received a minimum of 1 treatment regimen and a maximum of 2 treatment regimens, 1 of which must have been an anti-folate and platinum combination regimen.
    Protection of trial subjects
    The study was conducted in accordance with the Declaration of Helsinki and with all applicable laws and regulations of the locale and country where the study was conducted, and in compliance with Good Clinical Practice Guidelines.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Aug 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Russian Federation: 2
    Country: Number of subjects enrolled
    United States: 13
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    United Kingdom: 11
    Country: Number of subjects enrolled
    France: 15
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Italy: 1
    Worldwide total number of subjects
    53
    EEA total number of subjects
    23
    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)
    12
    From 65 to 84 years
    40
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Screening includes assessments to confirm eligibility (review of inclusion/exclusion criteria and review to confirm the MPM diagnosis).

    Period 1
    Period 1 title
    Treatment and follow up (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    rAd-IFN+Celecoxib+Gemcitabine
    Arm description
    Subjects received rAd-IFN, Celecoxib and Gemcitabine.
    Arm type
    Experimental

    Investigational medicinal product name
    rAd-IFN
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for suspension for injection
    Routes of administration
    Intrapleural use
    Dosage and administration details
    Subjects received 3 × 10^11 viral particles on Study Day 1 via intrapleural administration.

    Investigational medicinal product name
    Celecoxib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 400 mg twice daily on Study Days 1 to 14 administered orally.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    All patients took gemcitabine starting on Study Day 14, using the following treatment regimen: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21 day gemcitabine cycle, unless the cycle was modified due to toxicity/delay, and repeated every 3 weeks until disease progression/End of Trial.

    Arm title
    Celecoxib+Gemcitabine
    Arm description
    Subjects received Celecoxib and Gemcitabine.
    Arm type
    Active comparator

    Investigational medicinal product name
    Celecoxib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 400 mg twice daily on Study Days 1 to 14 administered orally.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    All patients took gemcitabine starting on Study Day 14, using the following treatment regimen: 1250 mg/m2 administered intravenously on Days 1 and 8 of a 21 day gemcitabine cycle, unless the cycle was modified due to toxicity/delay, and repeated every 3 weeks until disease progression/End of Trial.

    Number of subjects in period 1
    rAd-IFN+Celecoxib+Gemcitabine Celecoxib+Gemcitabine
    Started
    27
    26
    Completed
    0
    0
    Not completed
    27
    26
         Consent withdrawn by subject
    7
    4
         Physician decision
    -
    1
         Study terminated by Sponsor
    -
    1
         Adverse event, non-fatal
    4
    6
         Death
    1
    -
         Other
    2
    7
         Confirmed radiographic disease progression
    13
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    rAd-IFN+Celecoxib+Gemcitabine
    Reporting group description
    Subjects received rAd-IFN, Celecoxib and Gemcitabine.

    Reporting group title
    Celecoxib+Gemcitabine
    Reporting group description
    Subjects received Celecoxib and Gemcitabine.

    Reporting group values
    rAd-IFN+Celecoxib+Gemcitabine Celecoxib+Gemcitabine Total
    Number of subjects
    27 26 53
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    4 8 12
        From 65-84 years
    22 18 40
        85 years and over
    1 0 1
    Gender categorical
    Units: Subjects
        Female
    7 4 11
        Male
    20 22 42

    End points

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    End points reporting groups
    Reporting group title
    rAd-IFN+Celecoxib+Gemcitabine
    Reporting group description
    Subjects received rAd-IFN, Celecoxib and Gemcitabine.

    Reporting group title
    Celecoxib+Gemcitabine
    Reporting group description
    Subjects received Celecoxib and Gemcitabine.

    Subject analysis set title
    rAd-IFN+Celecoxib+Gemcitabine Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The Full Analysis Set included all patients appropriately randomized into the study who have received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).

    Subject analysis set title
    Celecoxib+Gemcitabine Full Analysis Set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The Full Analysis Set included all patients appropriately randomized into the study who have received at least 1 dose of study drug (rAd-IFN, celecoxib, or gemcitabine).

    Primary: Overall survival

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    End point title
    Overall survival
    End point description
    End point type
    Primary
    End point timeframe
    Overall survival defined as the time to death (from any cause) from randomization.
    End point values
    rAd-IFN+Celecoxib+Gemcitabine Full Analysis Set Celecoxib+Gemcitabine Full Analysis Set
    Number of subjects analysed
    27
    22
    Units: month
        number (confidence interval 95%)
    17.6 (8.3 to 31.8)
    15.5 (9.2 to 16.6)
    Statistical analysis title
    Treatment comparison
    Comparison groups
    rAd-IFN+Celecoxib+Gemcitabine Full Analysis Set v Celecoxib+Gemcitabine Full Analysis Set
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.284
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.83
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.43
         upper limit
    1.59

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events occurring from the time of the main study’s informed consent through 30 days after the last dose of study treatment (rAd-IFN, celecoxib, and gemcitabine).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    rAd-IFN+Celecoxib+Gemcitabine
    Reporting group description
    -

    Reporting group title
    Celecoxib+Gemcitabine
    Reporting group description
    -

    Serious adverse events
    rAd-IFN+Celecoxib+Gemcitabine Celecoxib+Gemcitabine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 27 (37.04%)
    12 / 22 (54.55%)
         number of deaths (all causes)
    22
    17
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Spinal cord injury thoracic
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    3 / 27 (11.11%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural infection
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Infection
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 22 (9.09%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    rAd-IFN+Celecoxib+Gemcitabine Celecoxib+Gemcitabine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 27 (100.00%)
    22 / 22 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 27 (7.41%)
    3 / 22 (13.64%)
         occurrences all number
    12
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    11 / 27 (40.74%)
    8 / 22 (36.36%)
         occurrences all number
    27
    20
    Asthenia
         subjects affected / exposed
    8 / 27 (29.63%)
    4 / 22 (18.18%)
         occurrences all number
    27
    5
    Oedema peripheral
         subjects affected / exposed
    6 / 27 (22.22%)
    5 / 22 (22.73%)
         occurrences all number
    8
    9
    Pyrexia
         subjects affected / exposed
    4 / 27 (14.81%)
    7 / 22 (31.82%)
         occurrences all number
    6
    12
    Non-cardiac chest pain
         subjects affected / exposed
    3 / 27 (11.11%)
    1 / 22 (4.55%)
         occurrences all number
    3
    1
    Chest pain
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 22 (4.55%)
         occurrences all number
    3
    1
    Catheter site extravasation
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    Malaise
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    Reproductive system and breast disorders
    Cough
         subjects affected / exposed
    4 / 27 (14.81%)
    3 / 22 (13.64%)
         occurrences all number
    4
    3
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    8 / 27 (29.63%)
    8 / 22 (36.36%)
         occurrences all number
    16
    10
    Dyspnoea exertional
         subjects affected / exposed
    3 / 27 (11.11%)
    1 / 22 (4.55%)
         occurrences all number
    3
    1
    Pleural effusion
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 22 (13.64%)
         occurrences all number
    1
    3
    Pneumothorax
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 27 (7.41%)
    3 / 22 (13.64%)
         occurrences all number
    2
    3
    Depression
         subjects affected / exposed
    1 / 27 (3.70%)
    3 / 22 (13.64%)
         occurrences all number
    1
    3
    Anxiety
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 22 (4.55%)
         occurrences all number
    2
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 27 (11.11%)
    3 / 22 (13.64%)
         occurrences all number
    5
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 27 (14.81%)
    2 / 22 (9.09%)
         occurrences all number
    5
    2
    Neutrophil count decreased
         subjects affected / exposed
    2 / 27 (7.41%)
    4 / 22 (18.18%)
         occurrences all number
    5
    10
    White blood cell count decreased
         subjects affected / exposed
    2 / 27 (7.41%)
    4 / 22 (18.18%)
         occurrences all number
    14
    9
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 27 (7.41%)
    3 / 22 (13.64%)
         occurrences all number
    3
    5
    Amylase increased
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 22 (9.09%)
         occurrences all number
    2
    2
    Blood creatinine increased
         subjects affected / exposed
    0 / 27 (0.00%)
    4 / 22 (18.18%)
         occurrences all number
    0
    4
    Platelet count decreased
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 22 (9.09%)
         occurrences all number
    7
    7
    Weight decreased
         subjects affected / exposed
    0 / 27 (0.00%)
    4 / 22 (18.18%)
         occurrences all number
    0
    4
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 27 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    0
    10
    Lipase increased
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 22 (4.55%)
         occurrences all number
    6
    2
    Lymphocyte count decreased
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 22 (4.55%)
         occurrences all number
    7
    1
    Body temperature increased
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    5 / 27 (18.52%)
    0 / 22 (0.00%)
         occurrences all number
    5
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 22 (9.09%)
         occurrences all number
    6
    2
    Headache
         subjects affected / exposed
    4 / 27 (14.81%)
    0 / 22 (0.00%)
         occurrences all number
    5
    0
    Lethargy
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 22 (4.55%)
         occurrences all number
    2
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    11 / 27 (40.74%)
    9 / 22 (40.91%)
         occurrences all number
    34
    18
    Neutropenia
         subjects affected / exposed
    5 / 27 (18.52%)
    6 / 22 (27.27%)
         occurrences all number
    10
    17
    Thrombocytopenia
         subjects affected / exposed
    3 / 27 (11.11%)
    2 / 22 (9.09%)
         occurrences all number
    3
    4
    Leukopenia
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 22 (4.55%)
         occurrences all number
    3
    3
    Thrombocytosis
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 22 (4.55%)
         occurrences all number
    2
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    17 / 27 (62.96%)
    7 / 22 (31.82%)
         occurrences all number
    39
    12
    Constipation
         subjects affected / exposed
    4 / 27 (14.81%)
    6 / 22 (27.27%)
         occurrences all number
    4
    7
    Vomiting
         subjects affected / exposed
    6 / 27 (22.22%)
    1 / 22 (4.55%)
         occurrences all number
    8
    1
    Abdominal pain
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 22 (9.09%)
         occurrences all number
    2
    2
    Diarrhoea
         subjects affected / exposed
    3 / 27 (11.11%)
    1 / 22 (4.55%)
         occurrences all number
    7
    1
    Abdominal distension
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 22 (9.09%)
         occurrences all number
    1
    2
    Dyspepsia
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 22 (4.55%)
         occurrences all number
    2
    1
    Stomatitis
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    Hepatobiliary disorders
    Hepatocellular injury
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 22 (9.09%)
         occurrences all number
    2
    3
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    4 / 27 (14.81%)
    4 / 22 (18.18%)
         occurrences all number
    4
    7
    Rash maculo-papular
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 22 (4.55%)
         occurrences all number
    3
    2
    Erythema
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    Hyperhidrosis
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 22 (0.00%)
         occurrences all number
    3
    0
    Night sweats
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    3 / 27 (11.11%)
    2 / 22 (9.09%)
         occurrences all number
    11
    9
    Haematuria
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    Urinary retention
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 22 (9.09%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    4 / 27 (14.81%)
    1 / 22 (4.55%)
         occurrences all number
    4
    1
    Myalgia
         subjects affected / exposed
    3 / 27 (11.11%)
    2 / 22 (9.09%)
         occurrences all number
    4
    3
    Arthralgia
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 22 (4.55%)
         occurrences all number
    2
    3
    Back pain
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 22 (4.55%)
         occurrences all number
    4
    1
    Muscular weakness
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 22 (9.09%)
         occurrences all number
    1
    2
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    5 / 27 (18.52%)
    0 / 22 (0.00%)
         occurrences all number
    5
    0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 22 (4.55%)
         occurrences all number
    3
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 22 (9.09%)
         occurrences all number
    1
    3
    Cystitis
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 22 (0.00%)
         occurrences all number
    4
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 27 (22.22%)
    6 / 22 (27.27%)
         occurrences all number
    9
    9
    Hypoalbuminaemia
         subjects affected / exposed
    3 / 27 (11.11%)
    2 / 22 (9.09%)
         occurrences all number
    4
    2
    Hyponatraemia
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 22 (9.09%)
         occurrences all number
    3
    2
    Hyperglycaemia
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 22 (9.09%)
         occurrences all number
    1
    2
    Hypokalaemia
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 22 (4.55%)
         occurrences all number
    2
    2
    Hypomagnesaemia
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 22 (9.09%)
         occurrences all number
    2
    2
    Hypophosphataemia
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 22 (4.55%)
         occurrences all number
    3
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Apr 2021
    The most important changes to the protocol are as follows: 1. Information on the discontinuation of enrollment into the trial has been added. 2. Information on statistical analysis and sample size determination have been updated in accordance with the lower number of trial subjects. 3. The two interim analyses have been removed from the protocol. 4. The expected time point for study completion has been amended. Please note that the definition of study completion remains unchanged as the “date of final statistical analysis”. However, the final statistical anaylsis will now be conducted after the forty-fourth event (death) or 30 months after the last patient is randomized, whichever occurs first. 5. A risk assessment for concomitant use of a COVID-19 vaccine for each IMP with specific consideration for the trial population has been added.
    13 Jul 2023
    Updates to the protocol include the following changes: • Modified end of study (study completion)-definition • Addition of a final statistical analysis comprised of an overall survival analysis. • Update of the Sponsor’s address (as notified previously) • Other minor edits were made throughout the document to correct grammatical errors and inconsistencies.
    11 Dec 2023
    Updates to the protocol include the following changes: • Following disease progression/ET, patients in the rAd-IFN treatment group will be followed every 6 months (±14 days) for survival and safety for up to 5 years after receiving the first dose of rAd-IFN • Patients in the control group will not continue in the clinical Follow-up phase and study participation will conclude after end of study treatment. • Other minor edits were made throughout the document to correct grammatical errors and inconsistencies.

    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.
    None reported
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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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