ID

27917

Descrição

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

Palavras-chave

Versões (2)
  1. 05/12/2017 05/12/2017 -
  2. 05/12/2017 05/12/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

5 de dezembro de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Chronic Hepatitis C Virus Infection NCT00851890

Inglês

Eligibility Chronic Hepatitis C Virus Infection NCT00851890

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
participant has provided written consent.
Descrição

Informed Consent

Tipo de dados

boolean

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

Postmenopausal state | Female Sterilization

Tipo de dados

boolean

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

Gender | Contraceptive methods Quantity

Tipo de dados

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.
Descrição

Hepatitis C virus genotype 1 | Hepatitis C virus RNA assay

Tipo de dados

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.
Descrição

Chronic Hepatitis C disease length

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

General health good | Exception Hepatitis C

Tipo de dados

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.
Descrição

Thyroid Disease Serum TSH level normal

Tipo de dados

boolean

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

Exclusion Criteria

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

Therapeutic procedure Absent Hepatitis C

Tipo de dados

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).
Descrição

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

Tipo de dados

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.
Descrição

Pregnancy | Breast Feeding | Partner Pregnant Women

Tipo de dados

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.
Descrição

Seizures | Malignant Neoplasms

Tipo de dados

boolean

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

Major Depressive Disorder

Tipo de dados

boolean

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

Liver Cirrhosis

Tipo de dados

boolean

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

Cause Any Liver disease | Exception Chronic Hepatitis C

Tipo de dados

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
Voltar ao início da página

Similar models

Eligibility Chronic Hepatitis C Virus Infection NCT00851890

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial