ID

42807

Description

Pegylated Interferon and Ribavirin in Hepatitis C Patients on Opioid Pharmacotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01120795

Link

https://clinicaltrials.gov/show/NCT01120795

Keywords

Versions (2)
  1. 8/7/16 8/7/16 -
  2. 9/17/21 9/17/21 -
Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis C NCT01120795

English

Eligibility Chronic Hepatitis C NCT01120795

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. 18 years of age or older
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. on opioid substitution therapy (methadone or buprenorphine)
Description

opioid substitution therapy (methadone or buprenorphine)

Data type

boolean

Alias
UMLS CUI [1]
C2936530
UMLS CUI [2]
C0025605
UMLS CUI [3]
C0006405
3. serologic evidence of chronic hepatitis c infection determined by a detectable anti-hcv antibody for 6 months or greater with evidence of detectable hcv rna
Description

chronic hepatitis c infection, anti-hcv antibody

Data type

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2]
C0166049
4. elevated alt on at least two occasions at least one month apart within the past 6 months, with at least one during the screening period preceding the initiation of study drug dosing.
Description

alt

Data type

boolean

Alias
UMLS CUI [1]
C0201836
5. hcv treatment-naïve
Description

hcv treatment naive

Data type

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0220847
6. liver biopsy findings consistent with the diagnosis of chronic hepatitis c infection (unless contraindicated due to a bleeding disorder)
Description

liver biopsy, chronic hepatitis c

Data type

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2]
C0524910
7. compensated liver disease (child-pugh grade a clinical classification).
Description

compensated liver disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205432
UMLS CUI [2]
C4050412
8. all fertile males and females receiving ribavirin were required to be using two forms of effective contraception during treatment and during the 6 months after treatment
Description

fertility, ribavirin treatment, contraception

Data type

boolean

Alias
UMLS CUI [1]
C0015895
UMLS CUI [2]
C0035525
UMLS CUI [3]
C0700589
9. women of child bearing potential were required to have a negative urine or blood pregnancy test documented within the 24-hour period prior to the first dose of study drug
Description

women of child bearing potential, negative pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0015894
UMLS CUI [2]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. women who were pregnant, breastfeeding or planning a pregnancy
Description

pregnant or breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. male partners of women who were pregnant
Description

male partners of women who were pregnant

Data type

boolean

Alias
UMLS CUI [1]
C0086582
3. patients who had previously received therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug
Description

systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation)

Data type

boolean

Alias
UMLS CUI [1]
C0003392
UMLS CUI [2]
C1963758
UMLS CUI [3]
C0034619
UMLS CUI [4]
C0038317
4. recipients of any investigational drug 4 weeks or 5 half lives, whichever was longer, prior to the first dose of study drug
Description

investigational drug

Data type

boolean

Alias
UMLS CUI [1]
C0013230
5. a positive test at screening for anti-hav igm ab, hbsag, anti-hbc igm ab, anti-hiv ab
Description

positive anti-hav igm ab, hbsag, anti-hbc igm ab, anti-hiv ab

Data type

boolean

Alias
UMLS CUI [1]
C0369327
UMLS CUI [2]
C0019168
UMLS CUI [3]
C2360515
UMLS CUI [4]
C0019683
6. a history or other evidence of a medical condition associated with chronic liver disease other than hcv
Description

comorbidity, chronic liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0341439
7. haemoglobin <12 g/dl in women or <13 g/dl in men, a neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening and serum creatinine level >1.5 times the upper limit of normal at screening.)
Description

Hemoglobin, neutrophiles, platelets, serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0200633
UMLS CUI [3]
C0005821
UMLS CUI [4]
C0201976
8. a history of a severe seizure disorder or current anticonvulsant use
Description

severe seizure disorder or current anticonvulsant use

Data type

boolean

Alias
UMLS CUI [1,1]
C0014544
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0003286
9. patients with a history of immunologically-mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, coronary artery disease, cerebrovascular disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
Description

immunologically-mediated disease, chronic pulmonary disease, severe cardiac disease, coronary artery disease, cerebrovascular disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0021053
UMLS CUI [3]
C0810290
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0010068
UMLS CUI [6]
C0007820
UMLS CUI [7]
C0029216
UMLS CUI [8]
C0006826
10. patients with a history of thyroid disease which is poorly controlled on prescribed medications
Description

thyroid disease

Data type

boolean

Alias
UMLS CUI [1]
C0040128
11. evidence of severe retinopathy
Description

severe retinopathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0035309
UMLS CUI [1,2]
C0205082
12. evidence of excessive substance abuse as judged by the investigator
Description

substance abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
13. patients with an increased baseline risk for anaemia (e.g. thalassaemia, spherocytosis, history of gastrointestinal bleeding, etc) or for whom anemia would be medically problematic.
Description

risk for anaemia

Data type

boolean

Alias
UMLS CUI [1,1]
C1444641
UMLS CUI [1,2]
C0002871
14. patients with a history of severe psychiatric disease (defined as acute phase of schizophrenia or bipolar disorder manic, mixed or depressive phase, severe anorexia, history of severe multiple episodes of self harm, currently screening as high or moderate suicide risk, current major depressive episode or current psychosis of any cause at screening)
Description

severe psychiatric disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205082
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Similar models

Eligibility Chronic Hepatitis C NCT01120795

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
1. 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
opioid substitution therapy (methadone or buprenorphine)
Item
2. on opioid substitution therapy (methadone or buprenorphine)
boolean
C2936530 (UMLS CUI [1])
C0025605 (UMLS CUI [2])
C0006405 (UMLS CUI [3])
chronic hepatitis c infection, anti-hcv antibody
Item
3. serologic evidence of chronic hepatitis c infection determined by a detectable anti-hcv antibody for 6 months or greater with evidence of detectable hcv rna
boolean
C0524910 (UMLS CUI [1])
C0166049 (UMLS CUI [2])
alt
Item
4. elevated alt on at least two occasions at least one month apart within the past 6 months, with at least one during the screening period preceding the initiation of study drug dosing.
boolean
C0201836 (UMLS CUI [1])
hcv treatment naive
Item
5. hcv treatment-naïve
boolean
C0919936 (UMLS CUI [1,1])
C0220847 (UMLS CUI [1,2])
liver biopsy, chronic hepatitis c
Item
6. liver biopsy findings consistent with the diagnosis of chronic hepatitis c infection (unless contraindicated due to a bleeding disorder)
boolean
C0193388 (UMLS CUI [1])
C0524910 (UMLS CUI [2])
compensated liver disease
Item
7. compensated liver disease (child-pugh grade a clinical classification).
boolean
C0023895 (UMLS CUI [1,1])
C0205432 (UMLS CUI [1,2])
C4050412 (UMLS CUI [2])
fertility, ribavirin treatment, contraception
Item
8. all fertile males and females receiving ribavirin were required to be using two forms of effective contraception during treatment and during the 6 months after treatment
boolean
C0015895 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
women of child bearing potential, negative pregnancy test
Item
9. women of child bearing potential were required to have a negative urine or blood pregnancy test documented within the 24-hour period prior to the first dose of study drug
boolean
C0015894 (UMLS CUI [1])
C0427780 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
pregnant or breastfeeding
Item
1. women who were pregnant, breastfeeding or planning a pregnancy
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
male partners of women who were pregnant
Item
2. male partners of women who were pregnant
boolean
C0086582 (UMLS CUI [1])
systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation)
Item
3. patients who had previously received therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug
boolean
C0003392 (UMLS CUI [1])
C1963758 (UMLS CUI [2])
C0034619 (UMLS CUI [3])
C0038317 (UMLS CUI [4])
investigational drug
Item
4. recipients of any investigational drug 4 weeks or 5 half lives, whichever was longer, prior to the first dose of study drug
boolean
C0013230 (UMLS CUI [1])
positive anti-hav igm ab, hbsag, anti-hbc igm ab, anti-hiv ab
Item
5. a positive test at screening for anti-hav igm ab, hbsag, anti-hbc igm ab, anti-hiv ab
boolean
C0369327 (UMLS CUI [1])
C0019168 (UMLS CUI [2])
C2360515 (UMLS CUI [3])
C0019683 (UMLS CUI [4])
comorbidity, chronic liver disease
Item
6. a history or other evidence of a medical condition associated with chronic liver disease other than hcv
boolean
C0009488 (UMLS CUI [1])
C0341439 (UMLS CUI [2])
Hemoglobin, neutrophiles, platelets, serum creatinine
Item
7. haemoglobin <12 g/dl in women or <13 g/dl in men, a neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening and serum creatinine level >1.5 times the upper limit of normal at screening.)
boolean
C0518015 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
severe seizure disorder or current anticonvulsant use
Item
8. a history of a severe seizure disorder or current anticonvulsant use
boolean
C0014544 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0003286 (UMLS CUI [2])
immunologically-mediated disease, chronic pulmonary disease, severe cardiac disease, coronary artery disease, cerebrovascular disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions
Item
9. patients with a history of immunologically-mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, coronary artery disease, cerebrovascular disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
boolean
C0009488 (UMLS CUI [1])
C0021053 (UMLS CUI [2])
C0810290 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0010068 (UMLS CUI [5])
C0007820 (UMLS CUI [6])
C0029216 (UMLS CUI [7])
C0006826 (UMLS CUI [8])
thyroid disease
Item
10. patients with a history of thyroid disease which is poorly controlled on prescribed medications
boolean
C0040128 (UMLS CUI [1])
severe retinopathy
Item
11. evidence of severe retinopathy
boolean
C0035309 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
substance abuse
Item
12. evidence of excessive substance abuse as judged by the investigator
boolean
C0038586 (UMLS CUI [1])
risk for anaemia
Item
13. patients with an increased baseline risk for anaemia (e.g. thalassaemia, spherocytosis, history of gastrointestinal bleeding, etc) or for whom anemia would be medically problematic.
boolean
C1444641 (UMLS CUI [1,1])
C0002871 (UMLS CUI [1,2])
severe psychiatric disease
Item
14. patients with a history of severe psychiatric disease (defined as acute phase of schizophrenia or bipolar disorder manic, mixed or depressive phase, severe anorexia, history of severe multiple episodes of self harm, currently screening as high or moderate suicide risk, current major depressive episode or current psychosis of any cause at screening)
boolean
C0004936 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
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