ID

39745

Beskrivning

Proof-of-concept Study Evaluating the Safety and Efficacy of EBP921 in Delta Hepatitis (HDV); ODM derived from: https://clinicaltrials.gov/show/NCT01316185

Länk

https://clinicaltrials.gov/show/NCT01316185

Nyckelord

Versioner (1)
  1. 2020-02-15 2020-02-15 -
Rättsinnehavare

See clinicaltrials.gov

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15 februari 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis D NCT01316185

Engelsk

Eligibility Hepatitis D NCT01316185

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. men and women age 18 or older with the capacity to give written informed consent
Beskrivning

Age | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
2. patients with compensated chronic hdv infection as indicated by presence of anti-hdv in serum.
Beskrivning

Chronic hepatitis D infection Compensated | Hepatitis D antibody Serum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2074980
UMLS CUI [1,2]
C0205432
UMLS CUI [2,1]
C0312635
UMLS CUI [2,2]
C0229671
3. liver biopsy should be performed within one-year of study screening and graded using the knodell scoring system.
Beskrivning

Biopsy of liver | Knodell Fibrosis Score

Datatyp

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2]
C3898641
4. presence of hdv antigen in liver tissue or hdv-rna in serum.
Beskrivning

Hepatitis delta Antigens Liver parenchyma | Hepatitis D virus RNA Serum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0057317
UMLS CUI [1,2]
C0736268
UMLS CUI [2,1]
C0486926
UMLS CUI [2,2]
C0229671
5. active hbv replication will not exclude patients.
Beskrivning

Hepatitis B Virus Replication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019169
UMLS CUI [1,2]
C0042774
6. previous therapy with standard alpha-interferon or peginterferon will not exclude patients.
Beskrivning

Prior Therapy | Interferon-alpha | PEGINTERFERON

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0002199
UMLS CUI [3]
C0982327
7. patients who are hbv therapy-naïve or who previously received hbv antiviral therapy will be eligible. patients currently taking hbv antiviral therapy will e considered on a case basis.
Beskrivning

Therapy naive Hepatitis B Virus | Antiviral Therapy Hepatitis B Virus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0019169
UMLS CUI [2,1]
C0280274
UMLS CUI [2,2]
C0019169
8. female subjects of reproductive potential and female partners of male subjects should be on two reliable forms of contraception from the start of the study until 60 days from the end of ebp921 dosing.
Beskrivning

Childbearing Potential Contraceptive methods Quantity | Gender Partner Contraceptive methods Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C0700589
UMLS CUI [2,4]
C1265611
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. severe neuropsychiatric disorders
Beskrivning

Neuropsychiatric syndrome Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3203509
UMLS CUI [1,2]
C0205082
2. history or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease
Beskrivning

Metabolic Disease | Hematological Disease | Lung disease | Myocardial Ischemia | Heart Disease | Heart Disease Unstable | Gastrointestinal Disease | Nervous system disorder | Kidney Disease | Urologic Disease | Endocrine System Disease | Disorder of eye | Retinal Disease Severe | Disease Immune-mediated

Datatyp

boolean

Alias
UMLS CUI [1]
C0025517
UMLS CUI [2]
C0018939
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0151744
UMLS CUI [5]
C0018799
UMLS CUI [6,1]
C0018799
UMLS CUI [6,2]
C0443343
UMLS CUI [7]
C0017178
UMLS CUI [8]
C0027765
UMLS CUI [9]
C0022658
UMLS CUI [10]
C0042075
UMLS CUI [11]
C0014130
UMLS CUI [12]
C0015397
UMLS CUI [13,1]
C0035309
UMLS CUI [13,2]
C0205082
UMLS CUI [14,1]
C0012634
UMLS CUI [14,2]
C4330477
3. pregnant or breast-feeding patients or the inability to practice adequate contraception during the conduct of the study
Beskrivning

Pregnancy | Breast Feeding | Contraceptive methods Unable

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C1299582
4. underlying autoimmune/immune-deficiency disease (e.g., lupus, sarcoidosis, celiac disease, hiv antibody positive, aids)
Beskrivning

Autoimmune Diseases | Immunologic Deficiency Syndromes | Lupus Erythematosus | Sarcoidosis | Celiac Disease | HIV antibody positive | AIDS

Datatyp

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0021051
UMLS CUI [3]
C0409974
UMLS CUI [4]
C0036202
UMLS CUI [5]
C0007570
UMLS CUI [6]
C0920548
UMLS CUI [7]
C0001175
5. chronic (> 4 weeks duration) diarrhea
Beskrivning

Chronic diarrhea Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0401151
UMLS CUI [1,2]
C0449238
6. body weight > 128 kg and < 40 kg
Beskrivning

Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
7. uncompensated cirrhosis
Beskrivning

Liver Cirrhosis Uncompensated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0205433
8. absolute neutrophil count less than 1500 per cubic millimeter
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
9. platelet count less than 90,000 per cubic millimeter
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
10. evidence of concurrent hcv infection with positive serum hcvrna
Beskrivning

Hepatitis C | Serum Hepatitis C RNA positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C0229671
UMLS CUI [2,2]
C0855842
11. evidence of hepatocellular carcinoma
Beskrivning

Liver carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
12. active substance abuse (alcohol, inhaled or injected drugs) within the past 12 months
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
13. diagnosis of malignancy in the previous five years excluding superficial dermatologic malignancies
Beskrivning

Malignant Neoplasms | Exception Malignant neoplasm of skin Superficial

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007114
UMLS CUI [2,3]
C0205124
14. any experimental therapy in the previous 6 months prior to enrollment.
Beskrivning

Therapy, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C0949266
16. patients with a history of multiple drug resistant hbv 17. patients receiving interferon therapy for any reason.
Beskrivning

Multi-Drug Resistance HBV | Interferon therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242640
UMLS CUI [1,2]
C0019169
UMLS CUI [2]
C0279030
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Similar models

Eligibility Hepatitis D NCT01316185

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Informed Consent
Item
1. men and women age 18 or older with the capacity to give written informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Chronic hepatitis D infection Compensated | Hepatitis D antibody Serum
Item
2. patients with compensated chronic hdv infection as indicated by presence of anti-hdv in serum.
boolean
C2074980 (UMLS CUI [1,1])
C0205432 (UMLS CUI [1,2])
C0312635 (UMLS CUI [2,1])
C0229671 (UMLS CUI [2,2])
Biopsy of liver | Knodell Fibrosis Score
Item
3. liver biopsy should be performed within one-year of study screening and graded using the knodell scoring system.
boolean
C0193388 (UMLS CUI [1])
C3898641 (UMLS CUI [2])
Hepatitis delta Antigens Liver parenchyma | Hepatitis D virus RNA Serum
Item
4. presence of hdv antigen in liver tissue or hdv-rna in serum.
boolean
C0057317 (UMLS CUI [1,1])
C0736268 (UMLS CUI [1,2])
C0486926 (UMLS CUI [2,1])
C0229671 (UMLS CUI [2,2])
Hepatitis B Virus Replication
Item
5. active hbv replication will not exclude patients.
boolean
C0019169 (UMLS CUI [1,1])
C0042774 (UMLS CUI [1,2])
Prior Therapy | Interferon-alpha | PEGINTERFERON
Item
6. previous therapy with standard alpha-interferon or peginterferon will not exclude patients.
boolean
C1514463 (UMLS CUI [1])
C0002199 (UMLS CUI [2])
C0982327 (UMLS CUI [3])
Therapy naive Hepatitis B Virus | Antiviral Therapy Hepatitis B Virus
Item
7. patients who are hbv therapy-naïve or who previously received hbv antiviral therapy will be eligible. patients currently taking hbv antiviral therapy will e considered on a case basis.
boolean
C0919936 (UMLS CUI [1,1])
C0019169 (UMLS CUI [1,2])
C0280274 (UMLS CUI [2,1])
C0019169 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods Quantity | Gender Partner Contraceptive methods Quantity
Item
8. female subjects of reproductive potential and female partners of male subjects should be on two reliable forms of contraception from the start of the study until 60 days from the end of ebp921 dosing.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Neuropsychiatric syndrome Severe
Item
1. severe neuropsychiatric disorders
boolean
C3203509 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Metabolic Disease | Hematological Disease | Lung disease | Myocardial Ischemia | Heart Disease | Heart Disease Unstable | Gastrointestinal Disease | Nervous system disorder | Kidney Disease | Urologic Disease | Endocrine System Disease | Disorder of eye | Retinal Disease Severe | Disease Immune-mediated
Item
2. history or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease
boolean
C0025517 (UMLS CUI [1])
C0018939 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0151744 (UMLS CUI [4])
C0018799 (UMLS CUI [5])
C0018799 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0017178 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0022658 (UMLS CUI [9])
C0042075 (UMLS CUI [10])
C0014130 (UMLS CUI [11])
C0015397 (UMLS CUI [12])
C0035309 (UMLS CUI [13,1])
C0205082 (UMLS CUI [13,2])
C0012634 (UMLS CUI [14,1])
C4330477 (UMLS CUI [14,2])
Pregnancy | Breast Feeding | Contraceptive methods Unable
Item
3. pregnant or breast-feeding patients or the inability to practice adequate contraception during the conduct of the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Autoimmune Diseases | Immunologic Deficiency Syndromes | Lupus Erythematosus | Sarcoidosis | Celiac Disease | HIV antibody positive | AIDS
Item
4. underlying autoimmune/immune-deficiency disease (e.g., lupus, sarcoidosis, celiac disease, hiv antibody positive, aids)
boolean
C0004364 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C0409974 (UMLS CUI [3])
C0036202 (UMLS CUI [4])
C0007570 (UMLS CUI [5])
C0920548 (UMLS CUI [6])
C0001175 (UMLS CUI [7])
Chronic diarrhea Duration
Item
5. chronic (> 4 weeks duration) diarrhea
boolean
C0401151 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Body Weight
Item
6. body weight > 128 kg and < 40 kg
boolean
C0005910 (UMLS CUI [1])
Liver Cirrhosis Uncompensated
Item
7. uncompensated cirrhosis
boolean
C0023890 (UMLS CUI [1,1])
C0205433 (UMLS CUI [1,2])
Absolute neutrophil count
Item
8. absolute neutrophil count less than 1500 per cubic millimeter
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
9. platelet count less than 90,000 per cubic millimeter
boolean
C0032181 (UMLS CUI [1])
Hepatitis C | Serum Hepatitis C RNA positive
Item
10. evidence of concurrent hcv infection with positive serum hcvrna
boolean
C0019196 (UMLS CUI [1])
C0229671 (UMLS CUI [2,1])
C0855842 (UMLS CUI [2,2])
Liver carcinoma
Item
11. evidence of hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Substance Use Disorders
Item
12. active substance abuse (alcohol, inhaled or injected drugs) within the past 12 months
boolean
C0038586 (UMLS CUI [1])
Malignant Neoplasms | Exception Malignant neoplasm of skin Superficial
Item
13. diagnosis of malignancy in the previous five years excluding superficial dermatologic malignancies
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007114 (UMLS CUI [2,2])
C0205124 (UMLS CUI [2,3])
Therapy, Investigational
Item
14. any experimental therapy in the previous 6 months prior to enrollment.
boolean
C0949266 (UMLS CUI [1])
Multi-Drug Resistance HBV | Interferon therapy
Item
16. patients with a history of multiple drug resistant hbv 17. patients receiving interferon therapy for any reason.
boolean
C0242640 (UMLS CUI [1,1])
C0019169 (UMLS CUI [1,2])
C0279030 (UMLS CUI [2])
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