ID

27909

Description

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

Keywords

Versions (1)
  1. 12/4/17 12/4/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 4, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT00962936

English

Eligibility Chronic Hepatitis C NCT00962936

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

boolean

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

Hepatitis C infection Genotype 1 Biopsy

Data type

boolean

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

Hepatitis C antibody positive

Data type

boolean

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

Chronic Hepatitis C Duration

Data type

boolean

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

ECOG performance status

Data type

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.
Description

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

Data type

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
Description

Exclusion Criteria

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

Antiviral Therapy

Data type

boolean

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

Malignant Neoplasms

Data type

boolean

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

Organ Transplantation Major | Functional status of graft

Data type

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.
Description

Systemic therapy

Data type

boolean

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

Patients Progressing to Acute Liver Failure

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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