ID

22455

Beschrijving

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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  1. 04-06-17 04-06-17 -
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GlaxoSmithKline

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4 juni 2017

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Creative Commons BY-NC 3.0
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Eligibility Criteria Day 1 Pre-Infusion Mepolizumab HES NCT00086658

Engels

Eligibility Criteria Day 1 Pre-Infusion

1 Formulieren  
ELIGIBILITY QUESTION
Beschrijving

ELIGIBILITY QUESTION

Alias
UMLS CUI-1
C1516637
Subject ID
Beschrijving

Subject ID

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

Visit Date

Datatype

date

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

Eligibility criteria

Datatype

boolean

Alias
UMLS CUI [1]
C1516637
INCLUSION CRITERIA
Beschrijving

INCLUSION CRITERIA

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

Informed consent

Datatype

boolean

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

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.

Datatype

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.
Beschrijving

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.

Datatype

boolean

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

Protocol completion

Datatype

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.
Beschrijving

Gender; Age; Pregnancy; Childbearing Potential; Contraceptive methods

Datatype

boolean

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

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.
Beschrijving

Comorbidity

Datatype

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
Beschrijving

Secondary eosinophilia drug eruption parasitic infection graft-versus host disease

Datatype

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
Beschrijving

Churg-Strauss Syndrome

Datatype

boolean

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

Wegeners Granulomatosis

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Serum creatinine; AST or/ALT; Platelet count

Datatype

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
Beschrijving

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

Datatype

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.
Beschrijving

Hypersensitivity antibody therapy

Datatype

boolean

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

Therapy monoclonal antibody

Datatype

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).
Beschrijving

Investigational drug

Datatype

boolean

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

Substance use disorder

Datatype

boolean

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

Positive serum pregnancy test

Datatype

boolean

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

Fusion Gene Positive

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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