ID

27917

Beschrijving

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-333 Alone and in Combination With Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00851890

Link

https://clinicaltrials.gov/show/NCT00851890

Trefwoorden

Versies (2)
  1. 05-12-17 05-12-17 -
  2. 05-12-17 05-12-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 december 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C Virus Infection NCT00851890

Engels

Eligibility Chronic Hepatitis C Virus Infection NCT00851890

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant has provided written consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
if female, participant is postmenopausal or surgically sterile.
Beschrijving

Postmenopausal state | Female Sterilization

Datatype

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
if male, must be practicing two effective methods of birth control.
Beschrijving

Gender | Contraceptive methods Quantity

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C1265611
participant is hepatitis c virus (hcv) genotype 1 with hcv ribonucleic acid levels >50,000 iu/ml.
Beschrijving

Hepatitis C virus genotype 1 | Hepatitis C virus RNA assay

Datatype

boolean

Alias
UMLS CUI [1]
C3532919
UMLS CUI [2]
C1272251
participants must demonstrate chronic hepatitis c infection for at least 6 months prior to study enrollment.
Beschrijving

Chronic Hepatitis C disease length

Datatype

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0872146
participants must have a liver biopsy with histology consistent with hcv-induced liver damage, and with no evidence of cirrhosis or liver pathology due to any cause other than chronic hcv.
Beschrijving

Histology Consistent with Hepatitis C Biopsy of liver | Absent Liver Cirrhosis Cause Other | Absent Liver disease Cause Other

Datatype

boolean

Alias
UMLS CUI [1,1]
C0344441
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0019196
UMLS CUI [1,4]
C0193388
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0023890
UMLS CUI [2,3]
C0015127
UMLS CUI [2,4]
C0205394
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0023895
UMLS CUI [3,3]
C0015127
UMLS CUI [3,4]
C0205394
condition of general good health other then hcv infection.
Beschrijving

General health good | Exception Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0019196
participants with a history of thyroid disease must have a thyroid stimulating hormone (tsh) value in the normal range.
Beschrijving

Thyroid Disease Serum TSH level normal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0040128
UMLS CUI [1,2]
C0580433
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
no prior history of receiving therapy for hcv infection.
Beschrijving

Therapeutic procedure Absent Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0019196
positive test result for hepatitis a virus immunoglobulin m (hav-igm), hepatitis b surface antigen (hbsag), or human immunodeficiency virus antibody (hiv ab).
Beschrijving

Hepatitis A IgM Positive | Hepatitis B surface antigen positive | HIV antibody positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0856422
UMLS CUI [1,2]
C1514241
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0920548
pregnant or breastfeeding females or male partners of women who are pregnant.
Beschrijving

Pregnancy | Breast Feeding | Partner Pregnant Women

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0682323
UMLS CUI [3,2]
C0033011
history of seizures or cancer.
Beschrijving

Seizures | Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0036572
UMLS CUI [2]
C0006826
history of major depressive disorder within 2 years.
Beschrijving

Major Depressive Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C1269683
any current or past history of cirrhosis.
Beschrijving

Liver Cirrhosis

Datatype

boolean

Alias
UMLS CUI [1]
C0023890
any cause of liver disease other than chronic hcv infection.
Beschrijving

Cause Any Liver disease | Exception Chronic Hepatitis C

Datatype

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C1552551
UMLS CUI [1,3]
C0023895
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0524910
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Similar models

Eligibility Chronic Hepatitis C Virus Infection NCT00851890

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
participant has provided written consent.
boolean
C0021430 (UMLS CUI [1])
Postmenopausal state | Female Sterilization
Item
if female, participant is postmenopausal or surgically sterile.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
Gender | Contraceptive methods Quantity
Item
if male, must be practicing two effective methods of birth control.
boolean
C0079399 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Hepatitis C virus genotype 1 | Hepatitis C virus RNA assay
Item
participant is hepatitis c virus (hcv) genotype 1 with hcv ribonucleic acid levels >50,000 iu/ml.
boolean
C3532919 (UMLS CUI [1])
C1272251 (UMLS CUI [2])
Chronic Hepatitis C disease length
Item
participants must demonstrate chronic hepatitis c infection for at least 6 months prior to study enrollment.
boolean
C0524910 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Histology Consistent with Hepatitis C Biopsy of liver | Absent Liver Cirrhosis Cause Other | Absent Liver disease Cause Other
Item
participants must have a liver biopsy with histology consistent with hcv-induced liver damage, and with no evidence of cirrhosis or liver pathology due to any cause other than chronic hcv.
boolean
C0344441 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
C0193388 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0023890 (UMLS CUI [2,2])
C0015127 (UMLS CUI [2,3])
C0205394 (UMLS CUI [2,4])
C0332197 (UMLS CUI [3,1])
C0023895 (UMLS CUI [3,2])
C0015127 (UMLS CUI [3,3])
C0205394 (UMLS CUI [3,4])
General health good | Exception Hepatitis C
Item
condition of general good health other then hcv infection.
boolean
C1277245 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
Thyroid Disease Serum TSH level normal
Item
participants with a history of thyroid disease must have a thyroid stimulating hormone (tsh) value in the normal range.
boolean
C0040128 (UMLS CUI [1,1])
C0580433 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure Absent Hepatitis C
Item
no prior history of receiving therapy for hcv infection.
boolean
C0087111 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Hepatitis A IgM Positive | Hepatitis B surface antigen positive | HIV antibody positive
Item
positive test result for hepatitis a virus immunoglobulin m (hav-igm), hepatitis b surface antigen (hbsag), or human immunodeficiency virus antibody (hiv ab).
boolean
C0856422 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0149709 (UMLS CUI [2])
C0920548 (UMLS CUI [3])
Pregnancy | Breast Feeding | Partner Pregnant Women
Item
pregnant or breastfeeding females or male partners of women who are pregnant.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0682323 (UMLS CUI [3,1])
C0033011 (UMLS CUI [3,2])
Seizures | Malignant Neoplasms
Item
history of seizures or cancer.
boolean
C0036572 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
Major Depressive Disorder
Item
history of major depressive disorder within 2 years.
boolean
C1269683 (UMLS CUI [1])
Liver Cirrhosis
Item
any current or past history of cirrhosis.
boolean
C0023890 (UMLS CUI [1])
Cause Any Liver disease | Exception Chronic Hepatitis C
Item
any cause of liver disease other than chronic hcv infection.
boolean
C0015127 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C0023895 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
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