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    Clinical Trial Results:
    A randomized and open-label dose-finding, phase 2, efficacy, safety, and pharmacokinetic study of once-per-cycle prophylactic injections of ANF-RHO™ versus pegfilgrastim (Neulasta®) in non-metastatic breast cancer patients at high risk of chemotherapy-induced neutropenia (CIN)

    Summary
    EudraCT number
    		 2016-001965-98
    Trial protocol
    		 NL  
    Global end of trial date
    17 Jan 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Feb 2020
    First version publication date
    11 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PGFN-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Prolong Pharmaceuticals, LLC
    Sponsor organisation address
    300 Corporate Court, Suite B, South Plainfield, New Jersey, United States, 07080
    Public contact
    Tara Chapman, Prolong Pharmaceuticals, LLC, 1 6095571237, tchapman@prolongmail.com
    Scientific contact
    Tara Chapman, Prolong Pharmaceuticals, LLC, 1 6095571237, tchapman@prolongmail.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
    19 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jan 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    • To assess the efficacy of escalating doses of ANF-RHO versus Neulasta in the duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] ≤ 2.0×109/L) in the first chemotherapy cycle (21-day cycle FE100C).
    Protection of trial subjects
    The clinical study discussed in this report was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulatory requirements. The Investigator must explain to each patient (or legally authorized representative) or parent the nature of the study, the purpose, the procedures involved, the expected duration, the potential benefits and risks involved, and any discomfort it may entail. The study drug should be identified as investigational (experimental) and that its side effects are not completely known. This information must be provided in language that the patient understands. Each patient must be informed that participation in the study is voluntary and that they may withdraw from the study at any time, and that withdrawal of consent will not affect their subsequent medical treatment or relationship with the treating physician. The patient should read and consider the statement before signing and dating it and should be given a copy of the signed document. No patient can enter the study before written informed consent/ assent has been obtained. The Investigator must assure that Patients’ anonymity will be strictly maintained and that their identities are protected from unauthorized parties.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2017
    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
    Netherlands: 9
    Worldwide total number of subjects
    9
    EEA total number of subjects
    9
    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)
    8
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from 4 sites in the Netherlands from 03 Aug 2017 through 22 May 2018.

    Pre-assignment
    Screening details
    		 Scheduled to receive and anticipated to complete the following chemotherapy regimen: FEC (flurouracil/epirubicin) [100]/cyclophosphamide (3 cycles); docetaxel (3 cycles) chemotherapy

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1
    Arm description
    		 10 µg/kg ANF-RHO on Cycle Day 1
    Arm type
    		 Experimental

    Investigational medicinal product name
    ANF-RHO
    Investigational medicinal product code
    PP-103
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10 µg/kg ANF-RHO by subcutaneous injection, once per chemotherapy cycle on Day 1

    Arm title
    		 Cohort 4
    Arm description
    		 6 mg Neulasta on Cycle Day 2
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Neulasta
    Investigational medicinal product code
    Neulasta
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    6 mg Neulasta on Cycle Day 2

    Number of subjects in period 1
    		Cohort 1 Cohort 4
    Started
    7
    2
    Completed
    4
    2
    Not completed
    3
    0
         Adverse event, non-fatal
    1
    -
         Lack of efficacy
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 10 µg/kg ANF-RHO on Cycle Day 1

    Reporting group title
    Cohort 4
    Reporting group description
    		 6 mg Neulasta on Cycle Day 2

    Reporting group values
    		 Cohort 1 Cohort 4 Total
    Number of subjects
    		 7 2 9
    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)
    		 6 2 8
        From 65-84 years
    		 1 0 1
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 55 (36 to 69) 59.5 (58 to 61) -
    Gender categorical
    Units: Subjects
        Female
    		 7 2 9
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 10 µg/kg ANF-RHO on Cycle Day 1

    Reporting group title
    Cohort 4
    Reporting group description
    		 6 mg Neulasta on Cycle Day 2

    Primary: Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] ≤ 2.0 x 109/L) in the first cycle of chemotherapy (FE100C).

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    End point title
    		 Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] ≤ 2.0 x 109/L) in the first cycle of chemotherapy (FE100C). [1]
    End point description
    End point type
    Primary
    End point timeframe
    First cycle of Chemotherapy (FE100C)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Study terminated early, no statistical analysis conducted
    End point values
    		 Cohort 1 Cohort 4
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Time
    Notes
    [2] - Study terminated early, no statistical analysis conducted
    [3] - Study terminated early, no statistical analysis conducted
    No statistical analyses for this end point

    Secondary: Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] ≤ 2.0 x 109/L) in the fourth cycle of chemotherapy (docetaxel).

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    End point title
    		 Duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] ≤ 2.0 x 109/L) in the fourth cycle of chemotherapy (docetaxel).
    End point description
    End point type
    Secondary
    End point timeframe
    Fourth cycle of chemotherapy (docetaxel)
    End point values
    		 Cohort 1 Cohort 4
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: Time
    Notes
    [4] - Study terminated early, no statistical analysis conducted
    [5] - Study terminated early, no statistical analysis conducted
    No statistical analyses for this end point

    Secondary: Duration of severe neutropenia (ANC < 0.5 x 109/L) during the first chemotherapy cycle (21-day cycle FE100C)

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    End point title
    		 Duration of severe neutropenia (ANC < 0.5 x 109/L) during the first chemotherapy cycle (21-day cycle FE100C)
    End point description
    End point type
    Secondary
    End point timeframe
    First chemotherapy cycle (21-day cycle FE100C)
    End point values
    		 Cohort 1 Cohort 4
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: Time
    Notes
    [6] - Study terminated early, no statistical analysis conducted
    [7] - Study terminated early, no statistical analysis conducted
    No statistical analyses for this end point

    Secondary: Duration of severe neutropenia (ANC < 0.5 x 109/L) during the fourth chemotherapy cycle (21-day cycle docetaxel)

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    End point title
    		 Duration of severe neutropenia (ANC < 0.5 x 109/L) during the fourth chemotherapy cycle (21-day cycle docetaxel)
    End point description
    End point type
    Secondary
    End point timeframe
    Fourth chemotherapy cycle (21-day cycle docetaxel)
    End point values
    		 Cohort 1 Cohort 4
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: Time
    Notes
    [8] - Study terminated early, no statistical analysis conducted
    [9] - Study terminated early, no statistical analysis conducted
    No statistical analyses for this end point

    Secondary: Incidence of severe neutropenia (ANC < 0.5 x 109/L) during all chemotherapy cycles

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    End point title
    		 Incidence of severe neutropenia (ANC < 0.5 x 109/L) during all chemotherapy cycles
    End point description
    End point type
    Secondary
    End point timeframe
    During all chemotherapy cycles
    End point values
    		 Cohort 1 Cohort 4
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: events of severe neutropenia
    Notes
    [10] - Study terminated early, no statistical analysis conducted
    [11] - Study terminated early, no statistical analysis conducted
    No statistical analyses for this end point

    Secondary: Incidence and duration of febrile neutropenia defined as peak temperature ≥38.5°C (or ≥38.0°C for two readings over two hours) and ANC < 0.5 x 109/L, during all chemotherapy cycles

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    End point title
    		 Incidence and duration of febrile neutropenia defined as peak temperature ≥38.5°C (or ≥38.0°C for two readings over two hours) and ANC < 0.5 x 109/L, during all chemotherapy cycles
    End point description
    End point type
    Secondary
    End point timeframe
    during all chemotherapy cycles
    End point values
    		 Cohort 1 Cohort 4
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: events of severe neutropenia & time
    Notes
    [12] - Study terminated early, no statistical analysis conducted
    [13] - Study terminated early, no statistical analysis conducted
    No statistical analyses for this end point

    Secondary: Incidence and duration of infection and infection-related events (e.g., antibiotic use, need for hospitalization, etc.) during all chemotherapy cycles

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    End point title
    		 Incidence and duration of infection and infection-related events (e.g., antibiotic use, need for hospitalization, etc.) during all chemotherapy cycles
    End point description
    End point type
    Secondary
    End point timeframe
    all chemotherapy cycles
    End point values
    		 Cohort 1 Cohort 4
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: Incidence & time
    Notes
    [14] - Study terminated early, no statistical analysis conducted
    [15] - Study terminated early, no statistical analysis conducted
    No statistical analyses for this end point

    Secondary: Incidence and duration of moderate (ANC ≥ 50 x 109/L) and severe (ANC ≥ 100 x 109/L) leukocytosis during all chemotherapy cycles

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    End point title
    		 Incidence and duration of moderate (ANC ≥ 50 x 109/L) and severe (ANC ≥ 100 x 109/L) leukocytosis during all chemotherapy cycles
    End point description
    End point type
    Secondary
    End point timeframe
    during all chemotherapy cycles
    End point values
    		 Cohort 1 Cohort 4
    Number of subjects analysed
    0 [16]
    0 [17]
    Units: Incidence & time
    Notes
    [16] - Study terminated early, no statistical analysis conducted
    [17] - Study terminated early, no statistical analysis conducted
    No statistical analyses for this end point

    Secondary: Clinically meaningful changes in vital signs during all chemotherapy cycles

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    End point title
    		 Clinically meaningful changes in vital signs during all chemotherapy cycles
    End point description
    End point type
    Secondary
    End point timeframe
    during all chemotherapy cycles
    End point values
    		 Cohort 1 Cohort 4
    Number of subjects analysed
    0 [18]
    0 [19]
    Units: vital signs
        number (not applicable)
    Notes
    [18] - Study terminated early, no statistical analysis conducted
    [19] - Study terminated early, no statistical analysis conducted
    No statistical analyses for this end point

    Secondary: Incidence, duration, severity and site of bone pain, determined by a numerical rating scale, as well as other reported adverse events

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    End point title
    		 Incidence, duration, severity and site of bone pain, determined by a numerical rating scale, as well as other reported adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    Through the completion of the clinical trial
    End point values
    		 Cohort 1 Cohort 4
    Number of subjects analysed
    0 [20]
    0 [21]
    Units: numberical rating scale
        number (not applicable)
    Notes
    [20] - Study terminated early, no statistical analysis conducted
    [21] - Study terminated early, no statistical analysis conducted
    No statistical analyses for this end point

    Secondary: Pharmacokinetic profile of ANF-RHO and Neulasta

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    End point title
    		 Pharmacokinetic profile of ANF-RHO and Neulasta
    End point description
    End point type
    Secondary
    End point timeframe
    through the end of the clinical trail
    End point values
    		 Cohort 1 Cohort 4
    Number of subjects analysed
    0 [22]
    0 [23]
    Units: pharmacokinetic profile
        number (not applicable)
    Notes
    [22] - Study terminated early, no statistical analysis conducted
    [23] - Study terminated early, no statistical analysis conducted
    No statistical analyses for this end point

    Secondary: Incidence of anti-drug antibodies to ANF-RHO and Neulasta

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    End point title
    		 Incidence of anti-drug antibodies to ANF-RHO and Neulasta
    End point description
    End point type
    Secondary
    End point timeframe
    Through the end of the clinical trial
    End point values
    		 Cohort 1 Cohort 4
    Number of subjects analysed
    0 [24]
    0 [25]
    Units: Incidence of anti-drug antibiodies
    Notes
    [24] - Study terminated early, no statistical analysis conducted
    [25] - Study terminated early, no statistical analysis conducted
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Continuous and 3 ± 2 days following study completion or early discontinuation; discontinuation due to study-related adverse event will be followed for 30 days or until the resolution or stabilization of the event
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Cohort 1
    Reporting group description
    		 10 µg/kg ANF-RHO on Cycle Day 1

    Reporting group title
    Cohort 4
    Reporting group description
    		 6 mg Neulasta on Cycle Day 2

    Serious adverse events
    		 Cohort 1 Cohort 4
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 7 (57.14%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Vitreous detachment
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (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
    Pulmonary embolism
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1 Cohort 4
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 7 (100.00%)
    2 / 2 (100.00%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 7 (57.14%)
    2 / 2 (100.00%)
         occurrences all number
    4
    4
    Mucosal inflammation
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 2 (50.00%)
         occurrences all number
    2
    1
    Pyrexia
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 2 (50.00%)
         occurrences all number
    2
    1
    Immune system disorders
    Allergy to chemicals
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Reproductive system and breast disorders
    Vulvovaginal inflammation
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Dyspnoea
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Gastric pH decreased
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 7 (28.57%)
    1 / 2 (50.00%)
         occurrences all number
    2
    1
    Polyneuropathy
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Headache
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Taste disorder
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 7 (71.43%)
    0 / 2 (0.00%)
         occurrences all number
    6
    0
    Diarrhoea
         subjects affected / exposed
    3 / 7 (42.86%)
    1 / 2 (50.00%)
         occurrences all number
    5
    1
    Vomiting
         subjects affected / exposed
    3 / 7 (42.86%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    Stomatitis
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Constipation
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Dry mouth
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Glossodynia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    5 / 7 (71.43%)
    2 / 2 (100.00%)
         occurrences all number
    5
    2
    Rash
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Onychalgia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Rosacea
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Skin reaction
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    3 / 7 (42.86%)
    1 / 2 (50.00%)
         occurrences all number
    4
    1
    Back pain
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Infections and infestations
    Herpes zoster
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Oral herpes
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    The study was terminated for business reasons because changes in standard of care were impractical to address. Limited study enrollment does not allow for efficacy analyses to be conducted.
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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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