ID

44356

Beskrivning

Phase I Safety and Tolerability Study of Birinapant in Chronic Hepatitis B; ODM derived from: https://clinicaltrials.gov/show/NCT02288208

Länk

https://clinicaltrials.gov/show/NCT02288208

Nyckelord

Versioner (2)
  1. 2020-01-28 2020-01-28 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis B NCT02288208

Engelsk

Eligibility Hepatitis B NCT02288208

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented history of chronic hepatitis b infection currently being treated with tenofovir or entecavir for at least 3 months
Beskrivning

Hepatitis B, Chronic | Tenofovir | entecavir

Datatyp

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2]
C0384228
UMLS CUI [3]
C0971023
measurable titer of hbsag
Beskrivning

Hepatitis B Surface Antigens Titer Measurable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019168
UMLS CUI [1,2]
C0475208
UMLS CUI [1,3]
C1513040
hbv dna level < 2 log copies/ml or 10² copies/ml
Beskrivning

Hepatitis B DNA Measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C3641250
no more than child-pugh score of 5 plus a valid fibroscan® of at least 10 readings with a median score of <7 and interquartile range of < 30%
Beskrivning

Child-Pugh Clinical Classification | Fibroscan | Score Median | Interquartile Range

Datatyp

boolean

Alias
UMLS CUI [1]
C4050412
UMLS CUI [2]
C4522043
UMLS CUI [3,1]
C0449820
UMLS CUI [3,2]
C2939193
UMLS CUI [4]
C1711350
adequate liver function, aspartate ast and alt ≤2 x uln
Beskrivning

Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
adequate renal function as evidenced by creatinine ≤2 mg/dl
Beskrivning

Renal function | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
participation in any interventional study within 4 weeks prior to screening
Beskrivning

Study Subject Participation Status | Interventional Study

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
known hiv infection, hepatitis c, or other significant hepatic disorder including cirrhosis (child-pugh class b or c)
Beskrivning

HIV Infection | Hepatitis C | Liver disease | Liver Cirrhosis Child-Pugh Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0023895
UMLS CUI [4,1]
C0023890
UMLS CUI [4,2]
C4050412
serious illness or autoimmune disease or other known liver disease
Beskrivning

Illness Serious | Autoimmune Disease | Liver diseases

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0004364
UMLS CUI [3]
C0023895
uncontrolled hypertension
Beskrivning

Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
impaired cardiac function, uncontrolled cardiac arrhythmias despite medications, or clinically significant cardiac disease
Beskrivning

Decreased cardiac function | Cardiac Arrhythmia Uncontrolled | Pharmacotherapy | Heart Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0232166
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0013216
UMLS CUI [4]
C0018799
currently breast feeding, pregnant or planning on becoming pregnant
Beskrivning

Breast Feeding | Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0032992
known allergy or hypersensitivity to any of the formulation components of birinapant or placebo, including citric acid
Beskrivning

Hypersensitivity Birinapant Component | Hypersensitivity Placebo Component | Hypersensitivity Citric Acid

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3658709
UMLS CUI [1,3]
C1705248
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0032042
UMLS CUI [2,3]
C1705248
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0055819
history of cranial nerve palsy
Beskrivning

Cranial nerve palsy

Datatyp

boolean

Alias
UMLS CUI [1]
C0151311
current treatment with anti-tnf therapies or has received treatment with anti-tnf therapies within the last 6 months
Beskrivning

Anti-tumor necrosis factor therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0281481
use of non-steroidal anti-inflammatory drugs
Beskrivning

Anti-Inflammatory Agents, Non-Steroidal

Datatyp

boolean

Alias
UMLS CUI [1]
C0003211
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Similar models

Eligibility Hepatitis B NCT02288208

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis B, Chronic | Tenofovir | entecavir
Item
documented history of chronic hepatitis b infection currently being treated with tenofovir or entecavir for at least 3 months
boolean
C0524909 (UMLS CUI [1])
C0384228 (UMLS CUI [2])
C0971023 (UMLS CUI [3])
Hepatitis B Surface Antigens Titer Measurable
Item
measurable titer of hbsag
boolean
C0019168 (UMLS CUI [1,1])
C0475208 (UMLS CUI [1,2])
C1513040 (UMLS CUI [1,3])
Hepatitis B DNA Measurement
Item
hbv dna level < 2 log copies/ml or 10² copies/ml
boolean
C3641250 (UMLS CUI [1])
Child-Pugh Clinical Classification | Fibroscan | Score Median | Interquartile Range
Item
no more than child-pugh score of 5 plus a valid fibroscan® of at least 10 readings with a median score of <7 and interquartile range of < 30%
boolean
C4050412 (UMLS CUI [1])
C4522043 (UMLS CUI [2])
C0449820 (UMLS CUI [3,1])
C2939193 (UMLS CUI [3,2])
C1711350 (UMLS CUI [4])
Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
adequate liver function, aspartate ast and alt ≤2 x uln
boolean
C0232741 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Renal function | Creatinine measurement, serum
Item
adequate renal function as evidenced by creatinine ≤2 mg/dl
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Interventional Study
Item
participation in any interventional study within 4 weeks prior to screening
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
HIV Infection | Hepatitis C | Liver disease | Liver Cirrhosis Child-Pugh Classification
Item
known hiv infection, hepatitis c, or other significant hepatic disorder including cirrhosis (child-pugh class b or c)
boolean
C0019693 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0023890 (UMLS CUI [4,1])
C4050412 (UMLS CUI [4,2])
Illness Serious | Autoimmune Disease | Liver diseases
Item
serious illness or autoimmune disease or other known liver disease
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0004364 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Decreased cardiac function | Cardiac Arrhythmia Uncontrolled | Pharmacotherapy | Heart Disease
Item
impaired cardiac function, uncontrolled cardiac arrhythmias despite medications, or clinically significant cardiac disease
boolean
C0232166 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0013216 (UMLS CUI [3])
C0018799 (UMLS CUI [4])
Breast Feeding | Pregnancy | Pregnancy, Planned
Item
currently breast feeding, pregnant or planning on becoming pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Hypersensitivity Birinapant Component | Hypersensitivity Placebo Component | Hypersensitivity Citric Acid
Item
known allergy or hypersensitivity to any of the formulation components of birinapant or placebo, including citric acid
boolean
C0020517 (UMLS CUI [1,1])
C3658709 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0032042 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0055819 (UMLS CUI [3,2])
Cranial nerve palsy
Item
history of cranial nerve palsy
boolean
C0151311 (UMLS CUI [1])
Anti-tumor necrosis factor therapy
Item
current treatment with anti-tnf therapies or has received treatment with anti-tnf therapies within the last 6 months
boolean
C0281481 (UMLS CUI [1])
Anti-Inflammatory Agents, Non-Steroidal
Item
use of non-steroidal anti-inflammatory drugs
boolean
C0003211 (UMLS CUI [1])
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