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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Investigate the Efficacy and Safety of Progesterone in Patients with Severe Traumatic Brain Injury

    Summary
    EudraCT number
    		 2010-018283-16
    Trial protocol
    		 BE   HU   GB   CZ   NL   AT   DE   ES   IT   FI  
    Global end of trial date
    06 Mar 2014

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BHR-100-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01143064
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BHR Pharma, LLC
    Sponsor organisation address
    607 Herndon Parkway Suite 110, Herndon, VA, United States, 20170
    Public contact
    Francois Brault, BHR Pharma Belgium, 0032 2629 43 11 N/A, EUclinicaltrials@bhr-pharma.com
    Scientific contact
    Francois Brault, BHR Pharma Belgium, 0032 2629 43 11 N/A, EUclinicaltrials@bhr-pharma.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
    06 Mar 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the study is to determine the efficacy and safety of BHR-100 i.v. progesterone infusion compared to placebo infusion, utilizing the glasgow outcome scale (GOS) in severe traumatic brain injury patients, glasgow coma scale (GCS 3-8), with the treatment administered continuously over 5 days beginning within 8 hours after the injury. In addition, the safety and clinical benefit of BHR-100 treatment will be assessed through the secondary endpoints.
    Protection of trial subjects
    Subjects were managed in accordance with standard guidelines for the treatment of severe TBI (Brain Trauma Foundation, American Brain Injury Consortium, and European Brain Injury Consortium).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jul 2010
    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
    Argentina: 64
    Country: Number of subjects enrolled
    China: 35
    Country: Number of subjects enrolled
    Israel: 62
    Country: Number of subjects enrolled
    Malaysia: 19
    Country: Number of subjects enrolled
    Romania: 6
    Country: Number of subjects enrolled
    Russian Federation: 13
    Country: Number of subjects enrolled
    Singapore: 15
    Country: Number of subjects enrolled
    Thailand: 46
    Country: Number of subjects enrolled
    Taiwan: 5
    Country: Number of subjects enrolled
    United States: 439
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Spain: 93
    Country: Number of subjects enrolled
    United Kingdom: 54
    Country: Number of subjects enrolled
    Austria: 32
    Country: Number of subjects enrolled
    Belgium: 29
    Country: Number of subjects enrolled
    Czechia: 58
    Country: Number of subjects enrolled
    Finland: 6
    Country: Number of subjects enrolled
    France: 92
    Country: Number of subjects enrolled
    Germany: 50
    Country: Number of subjects enrolled
    Hungary: 8
    Country: Number of subjects enrolled
    Italy: 46
    Worldwide total number of subjects
    1179
    EEA total number of subjects
    427
    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)
    24
    Adults (18-64 years)
    1089
    From 65 to 84 years
    66
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In total, 1195 subjects were randomized, however 16 subjects never received study drug and therefore the 1179 who received study drug were considered enrolled. All tables of the mITT population reflect only subjects who were randomized and received study drug treatment.

    Pre-assignment
    Screening details
    		 Inclusion and exclusion

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BHR-100
    Arm description
    		 Progesterone: Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Progesterone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs

    Arm title
    		 Placebo
    Arm description
    		 Lipid emulsion without progesterone: Intravenous administration equal to 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Drug: Lipid emulsion without progesterone Intravenous administration equal to 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.

    Number of subjects in period 1
    		BHR-100 Placebo
    Started
    591
    588
    Completed
    458
    473
    Not completed
    133
    115
         Adverse event, serious fatal
    109
    91
         Consent withdrawn by subject
    7
    5
         Physician decision
    -
    4
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    17
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BHR-100
    Reporting group description
    		 Progesterone: Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.

    Reporting group title
    Placebo
    Reporting group description
    		 Lipid emulsion without progesterone: Intravenous administration equal to 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.

    Reporting group values
    		 BHR-100 Placebo Total
    Number of subjects
    		 591 588 1179
    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)
    		 11 13 24
        Adults (18-64 years)
    		 545 544 1089
        From 65-84 years
    		 35 31 66
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 127 125 252
        Male
    		 464 463 927
    Subject analysis sets

    Subject analysis set title
    BHR-100
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Progesterone: Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Lipid emulsion without progesterone: Intravenous administration equal to 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.

    Subject analysis sets values
    		 BHR-100 Placebo
    Number of subjects
    591
    588
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    11
    13
        Adults (18-64 years)
    545
    544
        From 65-84 years
    35
    31
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    127
    125
        Male
    464
    463

    End points

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    End points reporting groups
    Reporting group title
    BHR-100
    Reporting group description
    		 Progesterone: Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.

    Reporting group title
    Placebo
    Reporting group description
    		 Lipid emulsion without progesterone: Intravenous administration equal to 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.

    Subject analysis set title
    BHR-100
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Progesterone: Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Lipid emulsion without progesterone: Intravenous administration equal to 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.

    Primary: Glasgow Outcome Scale (GOS)

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    End point title
    		 Glasgow Outcome Scale (GOS)
    End point description
    The GOS assesses mortality and disability in traumatic brain injury (TBI) patients according to the designation: Good Recovery, Moderate Disability, Severe Disability, Vegetative State or Dead.
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 BHR-100 Placebo
    Number of subjects analysed
    591
    588
    Units: Participants
        Good Recovery
    189
    183
        Moderate Disability
    109
    114
        Severe Disability
    162
    160
        Vegetative State / Dead
    131
    131
    Statistical analysis title
    		 Proportional Odds Model: Summary and Analysis
    Statistical analysis description
    analyzed by the Proportional Odds Model (POM).
    Comparison groups
    Placebo v BHR-100
    Number of subjects included in analysis
    1179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0098 [1]
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Confidence interval
    Notes
    [1] - The score test is based on the Chi-Square test and the Type 3 analysis of effects is based on the Wald Chi-Square test from a Logistic Regression analysis.

    Secondary: Mortality at Month 1

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    End point title
    		 Mortality at Month 1
    End point description
    The mortality rate at one month will be compared between the two treatment groups.
    End point type
    Secondary
    End point timeframe
    1 month post injury
    End point values
    		 BHR-100 Placebo
    Number of subjects analysed
    591
    588
    Units: Participants
        Lost to Follow Up
    0
    0
        Consent Withdrawn
    0
    0
        Alive
    500
    507
        Dead
    87
    74
        Other
    1
    0
        Missing
    3
    7
    No statistical analyses for this end point

    Secondary: Mortality at Month 6

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    End point title
    		 Mortality at Month 6
    End point description
    The mortality rate at six months will be compared between the two treatment groups.
    End point type
    Secondary
    End point timeframe
    6 months post injury
    End point values
    		 BHR-100 Placebo
    Number of subjects analysed
    591
    588
    Units: Participants
        Lost to Follow Up
    0
    2
        Consent Withdrawn
    0
    0
        Alive
    463
    472
        Dead
    109
    95
        Other
    0
    0
        Missing
    19
    19
    No statistical analyses for this end point

    Secondary: Glasgow Outcome Scale at 3 Months

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    End point title
    		 Glasgow Outcome Scale at 3 Months
    End point description
    The GOS assesses the mortality and disability in traumatic brain injury patients according to the designation: Good Recovery, Moderate Disability, Severe Disability, Vegetative State, or Dead.
    End point type
    Secondary
    End point timeframe
    Month 3
    End point values
    		 BHR-100 Placebo
    Number of subjects analysed
    591
    588
    Units: Participants
        Good Recovery
    103
    101
        Moderate Disability
    103
    114
        Severe Disability
    224
    216
        Vegetative State
    33
    49
        Dead
    102
    88
        Missing
    26
    20
    No statistical analyses for this end point

    Secondary: Glasgow Outcome Scale - Extended (GOS-E)

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    End point title
    		 Glasgow Outcome Scale - Extended (GOS-E)
    End point description
    The GOS-E assessment of mortality and disability in TBI patients extends the original five GOS categories of functional outcome to eight categories: • Dead • Vegetative State • Lower Severe Disability • Upper Severe Disability • Lower Moderate Disability • Upper Moderate Disability • Lower Good Recovery • Upper Good Recovery
    End point type
    Secondary
    End point timeframe
    3 months and 6 months post injury
    End point values
    		 BHR-100 Placebo
    Number of subjects analysed
    565
    568
    Units: Participants
        Dead- 3 months
    102
    88
        Vegetative State- 3 months
    33
    49
        Lower Severe Disability- 3 months
    173
    165
        Upper Severe Disability- 3 months
    51
    51
        Lower Moderate Disability- 3 months
    35
    34
        Upper Moderate Disability- 3 months
    68
    80
        Lower Good Recovery- 3months
    53
    46
        Upper Good Recovery- 3 months
    50
    55
        Dead- 6 months
    109
    95
        Vegetative State- 6 months
    20
    33
        Lower Severe Disability- 6 months
    115
    109
        Upper Severe Disability- 6 months
    37
    44
        Lower Moderate Disability- 6 months
    36
    38
        Upper Moderate Disability- 6 months
    70
    72
        Lower Good Recovery- 6 months
    71
    64
        Upper Good Recovery- 6 months
    108
    109
    No statistical analyses for this end point

    Secondary: Short Form (36) Health Survey (SF-36)

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    End point title
    		 Short Form (36) Health Survey (SF-36)
    End point description
    The SF-36 is a validated survey of patient health consisting of eight scaled scores. The eight sections are: • vitality • physical functioning • bodily pain • general health perceptions • role physical • role emotional • role mental • mental health The 8 scales can also be further summarized to provide a summary score for physical health and a summary score for mental health.
    End point type
    Secondary
    End point timeframe
    3 months and 6 months post injury
    End point values
    		 BHR-100 Placebo
    Number of subjects analysed
    354
    369
    Units: Score on a Scale
    number (not applicable)
        Physical Composite Summary- Month 3
    39.8
    40.6
        Physical Composite Summary- Month 6
    44.6
    45.1
        Mental Composite Summary- Month 3
    48.7
    48.5
        Mental Composite Summary- Month 6
    47.9
    46.8
    No statistical analyses for this end point

    Secondary: Potentially Clinically Important On-Treatment Cerebral Perfusion Pressure (CPP) and Summary of Maximum Therapy Therapeutic Intensity Level (TIL)

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    End point title
    		 Potentially Clinically Important On-Treatment Cerebral Perfusion Pressure (CPP) and Summary of Maximum Therapy Therapeutic Intensity Level (TIL)
    End point description
    Cerebral Perfusion Pressure (CPP) levels are presented according to clinically significant cut-off values. CPP was calculated from intracranial pressures and mean arterial pressures measured from Day through Day 6 after initiation of study medication, if an ICP monitor was in place. Specific therapies received during Days 1-6 are summarized according to the Therapeutic Intensity Level (TIL) by treatment group, as maximum level of therapy administered to the subject.
    End point type
    Secondary
    End point timeframe
    Admission through post-infusion Day 6
    End point values
    		 BHR-100 Placebo
    Number of subjects analysed
    591
    588
    Units: Participants
        Any CPP value <50 mmHg
    297
    299
        Any CPP value>=50<60 mmHg
    448
    460
        Any CPP value >=70 mmHg
    518
    523
        Surgical Decompression (TIL)
    192
    174
        Barbiturate Induced Coma (TIL)
    82
    73
        Hypothermia (TIL)
    61
    69
        Hyperventilation (TIL)
    78
    68
        Pressor Administered (TIL)
    315
    343
        Hypertonic Saline (TIL)
    225
    233
        Mannitol (TIL)
    288
    285
        Ventricular Drainage (TIL)
    198
    208
        Paralysis Induction (TIL)
    220
    231
        Sedation (TIL)
    565
    565
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening through end of study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    BHR-100
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 BHR-100 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    224 / 596 (37.58%)
    214 / 583 (36.71%)
         number of deaths (all causes)
    109
    95
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Brain contusion
         subjects affected / exposed
    5 / 596 (0.84%)
    6 / 583 (1.03%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain herniation
         subjects affected / exposed
    15 / 596 (2.52%)
    13 / 583 (2.23%)
         occurrences causally related to treatment / all
    0 / 15
    1 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural hematoma
         subjects affected / exposed
    10 / 596 (1.68%)
    5 / 583 (0.86%)
         occurrences causally related to treatment / all
    0 / 10
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic brain injury
         subjects affected / exposed
    4 / 596 (0.67%)
    10 / 583 (1.72%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    7 / 596 (1.17%)
    3 / 583 (0.51%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    6 / 596 (1.01%)
    5 / 583 (0.86%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    6 / 596 (1.01%)
    7 / 583 (1.20%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Brain Oedema
         subjects affected / exposed
    19 / 596 (3.19%)
    17 / 583 (2.92%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    8 / 596 (1.34%)
    5 / 583 (0.86%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    9 / 596 (1.51%)
    3 / 583 (0.51%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    12 / 596 (2.01%)
    14 / 583 (2.40%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial pressure increased
         subjects affected / exposed
    30 / 596 (5.03%)
    27 / 583 (4.63%)
         occurrences causally related to treatment / all
    1 / 30
    1 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress disorder
         subjects affected / exposed
    6 / 596 (1.01%)
    7 / 583 (1.20%)
         occurrences causally related to treatment / all
    0 / 6
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    5 / 596 (0.84%)
    9 / 583 (1.54%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    7 / 596 (1.17%)
    6 / 583 (1.03%)
         occurrences causally related to treatment / all
    2 / 7
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    4 / 596 (0.67%)
    11 / 583 (1.89%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Meningitis
         subjects affected / exposed
    7 / 596 (1.17%)
    5 / 583 (0.86%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    38 / 596 (6.38%)
    40 / 583 (6.86%)
         occurrences causally related to treatment / all
    0 / 40
    0 / 45
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    15 / 596 (2.52%)
    14 / 583 (2.40%)
         occurrences causally related to treatment / all
    0 / 15
    1 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    11 / 596 (1.85%)
    7 / 583 (1.20%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BHR-100 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    265 / 596 (44.46%)
    286 / 583 (49.06%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    30 / 596 (5.03%)
    18 / 583 (3.09%)
         occurrences all number
    30
    18
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    51 / 596 (8.56%)
    35 / 583 (6.00%)
         occurrences all number
    51
    35
    Vascular disorders
    Hypertension
         subjects affected / exposed
    129 / 596 (21.64%)
    127 / 583 (21.78%)
         occurrences all number
    135
    143
    Hypotension
         subjects affected / exposed
    71 / 596 (11.91%)
    80 / 583 (13.72%)
         occurrences all number
    76
    88
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    69 / 596 (11.58%)
    63 / 583 (10.81%)
         occurrences all number
    73
    65
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    156 / 596 (26.17%)
    159 / 583 (27.27%)
         occurrences all number
    173
    171
    Thrombocytopenia
         subjects affected / exposed
    21 / 596 (3.52%)
    32 / 583 (5.49%)
         occurrences all number
    21
    32
    Gastrointestinal disorders
    Pyrexia
         subjects affected / exposed
    209 / 596 (35.07%)
    229 / 583 (39.28%)
         occurrences all number
    223
    249
    Constipation
         subjects affected / exposed
    97 / 596 (16.28%)
    102 / 583 (17.50%)
         occurrences all number
    97
    105
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    79 / 596 (13.26%)
    78 / 583 (13.38%)
         occurrences all number
    81
    85
    Endocrine disorders
    Diabetes insipidus
         subjects affected / exposed
    33 / 596 (5.54%)
    43 / 583 (7.38%)
         occurrences all number
    33
    44
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    86 / 596 (14.43%)
    85 / 583 (14.58%)
         occurrences all number
    87
    87
    Hypernatraemia
         subjects affected / exposed
    39 / 596 (6.54%)
    33 / 583 (5.66%)
         occurrences all number
    42
    34
    Hypocalcaemia
         subjects affected / exposed
    22 / 596 (3.69%)
    29 / 583 (4.97%)
         occurrences all number
    22
    30
    Hypokalaemia
         subjects affected / exposed
    94 / 596 (15.77%)
    126 / 583 (21.61%)
         occurrences all number
    102
    132
    Hypomagnesaemia
         subjects affected / exposed
    32 / 596 (5.37%)
    49 / 583 (8.40%)
         occurrences all number
    32
    49
    Hyponatraemia
         subjects affected / exposed
    59 / 596 (9.90%)
    64 / 583 (10.98%)
         occurrences all number
    64
    68
    Hypophosphataemia
         subjects affected / exposed
    53 / 596 (8.89%)
    52 / 583 (8.92%)
         occurrences all number
    53
    53

    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.
    16 pts haven’t received study drugs. 6 BHR-100, 10 placebo.1179 made the mITT population (591+588). Data isn’t available for causality of deaths. Feedback from EudraCT IT on 20-01-2026, we have entered '0' for the deaths values that weren’t 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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