ID

27909

Descripción

Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00962936

Link

https://clinicaltrials.gov/show/NCT00962936

Palabras clave

Versiones (1)
  1. 4/12/17 4/12/17 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

4 de diciembre de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT00962936

Inglés

Eligibility Chronic Hepatitis C NCT00962936

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient is between 18 and 60 years of age, both genders.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. biopsy proven infection with hepatitis c genotype 1.
Descripción

Hepatitis C infection Genotype 1 Biopsy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C3532919
UMLS CUI [1,3]
C0005558
3. positive for anti-hcv.
Descripción

Hepatitis C antibody positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0281863
4. chronically infected for at least 3 months from diagnosis.
Descripción

Chronic Hepatitis C Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C0449238
5. ecog performance status ≤ 1.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
6. previous therapy with interferon +/- ribavirin or peginterferon +/- ribavirin or ineligibility for this type of therapy or for liver transplantation.
Descripción

Interferon | Ribavirin | Peginterferon | Ineligibility Therapeutic procedure Specified | Ineligibility Transplantation of liver

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021747
UMLS CUI [2]
C0035525
UMLS CUI [3]
C0982327
UMLS CUI [4,1]
C1512714
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C0205369
UMLS CUI [5,1]
C1512714
UMLS CUI [5,2]
C0023911
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who received any type of anti viral treatment during the 3 months prior to enrollment.
Descripción

Antiviral Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0280274
2. any history or active malignancy.
Descripción

Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
3. history of major organ transplantation with an existing functional graft.
Descripción

Organ Transplantation Major | Functional status of graft

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0029216
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C1717849
4. patients who received any systemic concurrent therapy within the last 4 weeks.
Descripción

Systemic therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1515119
5. patients progressing to acute liver failure (alf).
Descripción

Patients Progressing to Acute Liver Failure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0205329
UMLS CUI [1,3]
C0162557
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Similar models

Eligibility Chronic Hepatitis C NCT00962936

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patient is between 18 and 60 years of age, both genders.
boolean
C0001779 (UMLS CUI [1])
Hepatitis C infection Genotype 1 Biopsy
Item
2. biopsy proven infection with hepatitis c genotype 1.
boolean
C0019196 (UMLS CUI [1,1])
C3532919 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
Hepatitis C antibody positive
Item
3. positive for anti-hcv.
boolean
C0281863 (UMLS CUI [1])
Chronic Hepatitis C Duration
Item
4. chronically infected for at least 3 months from diagnosis.
boolean
C0524910 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
ECOG performance status
Item
5. ecog performance status ≤ 1.
boolean
C1520224 (UMLS CUI [1])
Interferon | Ribavirin | Peginterferon | Ineligibility Therapeutic procedure Specified | Ineligibility Transplantation of liver
Item
6. previous therapy with interferon +/- ribavirin or peginterferon +/- ribavirin or ineligibility for this type of therapy or for liver transplantation.
boolean
C0021747 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
C0982327 (UMLS CUI [3])
C1512714 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C0205369 (UMLS CUI [4,3])
C1512714 (UMLS CUI [5,1])
C0023911 (UMLS CUI [5,2])
Item Group
C0680251 (UMLS CUI)
Antiviral Therapy
Item
1. patients who received any type of anti viral treatment during the 3 months prior to enrollment.
boolean
C0280274 (UMLS CUI [1])
Malignant Neoplasms
Item
2. any history or active malignancy.
boolean
C0006826 (UMLS CUI [1])
Organ Transplantation Major | Functional status of graft
Item
3. history of major organ transplantation with an existing functional graft.
boolean
C0029216 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1717849 (UMLS CUI [2])
Systemic therapy
Item
4. patients who received any systemic concurrent therapy within the last 4 weeks.
boolean
C1515119 (UMLS CUI [1])
Patients Progressing to Acute Liver Failure
Item
5. patients progressing to acute liver failure (alf).
boolean
C0030705 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0162557 (UMLS CUI [1,3])
Volver a la parte superior de la página 

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