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22455

Description

Study part: Eligibility Criteria Day 1 Pre-Infusion.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

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Versions (1)
  1. 6/4/17 6/4/17 -
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GlaxoSmithKline

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June 4, 2017

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    Eligibility Criteria Day 1 Pre-Infusion Mepolizumab HES NCT00086658

    English

    Eligibility Criteria Day 1 Pre-Infusion

    1 forms  
    ELIGIBILITY QUESTION
    Description

    ELIGIBILITY QUESTION

    Alias
    UMLS CUI-1
    C1516637
    Subject ID
    Description

    Subject ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Did the subject meet all the entry criteria?
    Description

    Eligibility criteria

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1516637
    INCLUSION CRITERIA
    Description

    INCLUSION CRITERIA

    Alias
    UMLS CUI-1
    C1512693
    1. Signed informed consent.
    Description

    Informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    2. Subjects with documented history of HES.
    Description

    HES is defined as: 1) peripheral blood eosinophilia (>1500 eosinophils/ μL) for at least 6 months, 2) signs and symptoms of organ system involvement or dysfunction that can be directly related to eosinophilia, 3) no evidence of parasitic, allergic, or other recognized causes of eosinophilia after comprehensive evaluation. Note: Subjects with sustained peripheral hypereosinophilia of >1500 eosinophils/μL for a duration of<6 months may be included if they meet the rest of the HES criteria accompanied by clear evidence of eosinophil tissue infiltration.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C1540912
    3. Subjects must achieve and maintain a stable prednisone monotherapy status prior to randomization.
    Description

    A stable prednisone monotherapy status is defined as: No new or worsening HES clinical signs and symptoms with a blood eosinophil count less than 1000/ μL when treated with prednisone monotherapy at a stable daily dose of ≥ 20 mg to ≤ 50 mg for a minimum of one week. Note: Subjects who are adequately controlled on < 20mg prednisone monotherapy (i.e. blood eosinophil count < 750/μl with no new or worsening of HES signs and symptoms)may not be randomized with a short term increase of prednisone dose to meet the inclusion criteria. In essence, subjects must require ≥ 20mg prednisone monotherapy to achieve a blood eosinophil count < 1000/ul and maintains stable HES signs and symptoms in order to be randomized.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0747791
    4. Subjects must complete all the screening/baseline assessments as outlined in the protocol.
    Description

    Protocol completion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826674
    5. Male or female, 18-75 years of age. A female subject is eligible to enter the study if she is: • Not pregnant or nursing • Of non-childbearing potential (i.e., women who had a hysterectomy, are post-menopausal which is defined as 1 year without menses, have both ovaries surgically removed, or have current documented tubule ligation); or • Of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at the Screening Visit, and agree to one of the following: 1). Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of investigational product until 3 months after the last dose of investigational product; or 2). Consistent and correct use of one of the following acceptable methods of birth control for one month prior to the start of the investigation product and three months after the last dose: • Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subjects; • Implants of levonorgestrel; • Injectable progestogen; • Any intrauterine device (IUD) with a documented failure rate of less than 1% per year; • Oral contraceptives (either combined or progestogen only) • Double-barrier methods including diaphragm or condom with a spermicide.
    Description

    Gender; Age; Pregnancy; Childbearing Potential; Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0001779
    UMLS CUI [3]
    C0032961
    UMLS CUI [4]
    C3831118
    UMLS CUI [5]
    C0700589
    EXCLUSION CRITERIA
    Description

    EXCLUSION CRITERIA

    Alias
    UMLS CUI-1
    C0680251
    1. Subjects with life-threatening or other serious illness or clinical manifestation deemed inappropriate for inclusion in study per the principal investigator.
    Description

    Comorbidity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    2. Known secondary causes of eosinophilia: drug eruption and parasitic infection occurring within a year prior to the Screening Visit, history of graft-versus host disease, bullous pemphigoid, cystic fibrosis, rheumatoid arthritis and human immunodeficiency virus (HIV) infection
    Description

    Secondary eosinophilia drug eruption parasitic infection graft-versus host disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0272194
    UMLS CUI [1,2]
    C0011609
    UMLS CUI [1,3]
    C0747256
    UMLS CUI [1,4]
    C0018133
    3. Known Churg-Strauss Syndrome
    Description

    Churg-Strauss Syndrome

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0008728
    4. Known Wegener's Granulomatosis
    Description

    Wegeners Granulomatosis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3495801
    5. Known lymphoma, hematological malignancy, advanced and metastatic solid tumors and/or subjects who are under chemotherapy, radiotherapy or interleukin 2 treatment
    Description

    medical history malignant Neoplasms; Therapy chemotherapy radiotherapy Interleukin-2 therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0006826
    UMLS CUI [2,1]
    C0087111
    UMLS CUI [2,2]
    C0392920
    UMLS CUI [2,3]
    C1522449
    UMLS CUI [2,4]
    C0199975
    6. Abnormal laboratory value of: • Serum creatinine ≥ 3 times institutional upper limit normal (ULN) • AST or/ALT ≥ 5 times institutional ULN • Platelet count < 50,000/ μ L
    Description

    Serum creatinine; AST or/ALT; Platelet count

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    UMLS CUI [2]
    C3831581
    UMLS CUI [3]
    C0032181
    7. Cardiac function as the following: • Left ventricular ejection fraction (LVEF) < 20%. (Subject with a history of LVEF <20% within 6 months prior to screening should also be excluded). • NYHA class IIIb or IV • Angina or acute myocardial infarction
    Description

    Cardiac function LVEF NYHA class IIIb or IV Angina Pectoris acute myocardial infarction

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0232164
    UMLS CUI [1,2]
    C0428772
    UMLS CUI [1,3]
    C0278962
    UMLS CUI [1,4]
    C0002962
    UMLS CUI [1,5]
    C0155626
    8. Known history of allergic reaction to previous antibody therapy.
    Description

    Hypersensitivity antibody therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0281176
    9. Prior treatment with an anti-hIL-5 monoclonal antibody.
    Description

    Therapy monoclonal antibody

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0003250
    10. Use of an investigational drug within 30 days of entering the study (Screening Visit).
    Description

    Investigational drug

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    11. Recent history or suspicion of current drug abuse or alcohol abuse within the last 6 months.
    Description

    Substance use disorder

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    12. Positive serum pregnancy test at the Screening Visit or urine pregnancy test at Baseline Visit.
    Description

    Positive serum pregnancy test

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0430063
    13. Test positive for FIP1L1-PDGFR α fusion gene.
    Description

    Fusion Gene Positive

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1533585
    UMLS CUI [1,2]
    C1446409
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    Similar models

    Eligibility Criteria Day 1 Pre-Infusion

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    ELIGIBILITY QUESTION
    C1516637 (UMLS CUI-1)
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Eligibility criteria
    Item
    Did the subject meet all the entry criteria?
    boolean
    C1516637 (UMLS CUI [1])
    Item Group
    INCLUSION CRITERIA
    C1512693 (UMLS CUI-1)
    Informed consent
    Item
    1. Signed informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Medical history Hypereosinophilic Syndrome
    Item
    2. Subjects with documented history of HES.
    boolean
    C0262926 (UMLS CUI [1,1])
    C1540912 (UMLS CUI [1,2])
    prednisone treatment
    Item
    3. Subjects must achieve and maintain a stable prednisone monotherapy status prior to randomization.
    boolean
    C0747791 (UMLS CUI [1])
    Protocol completion
    Item
    4. Subjects must complete all the screening/baseline assessments as outlined in the protocol.
    boolean
    C2826674 (UMLS CUI [1])
    Gender; Age; Pregnancy; Childbearing Potential; Contraceptive methods
    Item
    5. Male or female, 18-75 years of age. A female subject is eligible to enter the study if she is: • Not pregnant or nursing • Of non-childbearing potential (i.e., women who had a hysterectomy, are post-menopausal which is defined as 1 year without menses, have both ovaries surgically removed, or have current documented tubule ligation); or • Of childbearing potential (i.e., women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at the Screening Visit, and agree to one of the following: 1). Complete abstinence from intercourse from 2 weeks prior to administration of the first dose of investigational product until 3 months after the last dose of investigational product; or 2). Consistent and correct use of one of the following acceptable methods of birth control for one month prior to the start of the investigation product and three months after the last dose: • Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subjects; • Implants of levonorgestrel; • Injectable progestogen; • Any intrauterine device (IUD) with a documented failure rate of less than 1% per year; • Oral contraceptives (either combined or progestogen only) • Double-barrier methods including diaphragm or condom with a spermicide.
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    C0032961 (UMLS CUI [3])
    C3831118 (UMLS CUI [4])
    C0700589 (UMLS CUI [5])
    Item Group
    EXCLUSION CRITERIA
    C0680251 (UMLS CUI-1)
    Comorbidity
    Item
    1. Subjects with life-threatening or other serious illness or clinical manifestation deemed inappropriate for inclusion in study per the principal investigator.
    boolean
    C0009488 (UMLS CUI [1])
    Secondary eosinophilia drug eruption parasitic infection graft-versus host disease
    Item
    2. Known secondary causes of eosinophilia: drug eruption and parasitic infection occurring within a year prior to the Screening Visit, history of graft-versus host disease, bullous pemphigoid, cystic fibrosis, rheumatoid arthritis and human immunodeficiency virus (HIV) infection
    boolean
    C0272194 (UMLS CUI [1,1])
    C0011609 (UMLS CUI [1,2])
    C0747256 (UMLS CUI [1,3])
    C0018133 (UMLS CUI [1,4])
    Churg-Strauss Syndrome
    Item
    3. Known Churg-Strauss Syndrome
    boolean
    C0008728 (UMLS CUI [1])
    Wegeners Granulomatosis
    Item
    4. Known Wegener's Granulomatosis
    boolean
    C3495801 (UMLS CUI [1])
    medical history malignant Neoplasms; Therapy chemotherapy radiotherapy Interleukin-2 therapy
    Item
    5. Known lymphoma, hematological malignancy, advanced and metastatic solid tumors and/or subjects who are under chemotherapy, radiotherapy or interleukin 2 treatment
    boolean
    C0262926 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [2,1])
    C0392920 (UMLS CUI [2,2])
    C1522449 (UMLS CUI [2,3])
    C0199975 (UMLS CUI [2,4])
    Serum creatinine; AST or/ALT; Platelet count
    Item
    6. Abnormal laboratory value of: • Serum creatinine ≥ 3 times institutional upper limit normal (ULN) • AST or/ALT ≥ 5 times institutional ULN • Platelet count < 50,000/ μ L
    boolean
    C0201976 (UMLS CUI [1])
    C3831581 (UMLS CUI [2])
    C0032181 (UMLS CUI [3])
    Cardiac function LVEF NYHA class IIIb or IV Angina Pectoris acute myocardial infarction
    Item
    7. Cardiac function as the following: • Left ventricular ejection fraction (LVEF) < 20%. (Subject with a history of LVEF <20% within 6 months prior to screening should also be excluded). • NYHA class IIIb or IV • Angina or acute myocardial infarction
    boolean
    C0232164 (UMLS CUI [1,1])
    C0428772 (UMLS CUI [1,2])
    C0278962 (UMLS CUI [1,3])
    C0002962 (UMLS CUI [1,4])
    C0155626 (UMLS CUI [1,5])
    Hypersensitivity antibody therapy
    Item
    8. Known history of allergic reaction to previous antibody therapy.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0281176 (UMLS CUI [1,2])
    Therapy monoclonal antibody
    Item
    9. Prior treatment with an anti-hIL-5 monoclonal antibody.
    boolean
    C0087111 (UMLS CUI [1,1])
    C0003250 (UMLS CUI [1,2])
    Investigational drug
    Item
    10. Use of an investigational drug within 30 days of entering the study (Screening Visit).
    boolean
    C0013230 (UMLS CUI [1])
    Substance use disorder
    Item
    11. Recent history or suspicion of current drug abuse or alcohol abuse within the last 6 months.
    boolean
    C0038586 (UMLS CUI [1])
    Positive serum pregnancy test
    Item
    12. Positive serum pregnancy test at the Screening Visit or urine pregnancy test at Baseline Visit.
    boolean
    C0430063 (UMLS CUI [1])
    Fusion Gene Positive
    Item
    13. Test positive for FIP1L1-PDGFR α fusion gene.
    boolean
    C1533585 (UMLS CUI [1,1])
    C1446409 (UMLS CUI [1,2])
    Back to the top of the page 

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