ID

24283

Description

Efficacy of PegIntron (Peginterferon Alfa-2b) and Rebetol (Ribavirin) in Treatment-naïve Subjects With Chronic Hepatitis C in Clinical Practice in Greece (Study P05209); ODM derived from: https://clinicaltrials.gov/show/NCT00724464

Link

https://clinicaltrials.gov/show/NCT00724464

Keywords

Versions (1)
  1. 7/28/17 7/28/17 -
Uploaded on

July 28, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT00724464

English

Eligibility Hepatitis C, Chronic NCT00724464

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants who have already begun summary of product characteristics (smpc)-based combination treatment with pegylated interferon alpha-2b and ribavirin, prior to the site initiation date.
Description

Combined Modality Therapy Started | peginterferon alfa-2b | Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C1272689
UMLS CUI [2]
C0796545
UMLS CUI [3]
C0035525
participants who have been receiving combination treatment with pegylated interferon alpha-2b and ribavirin for at least 6 months before enrollment.
Description

Combined Modality Therapy Previous | peginterferon alfa-2b | Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0796545
UMLS CUI [3]
C0035525
participants who have achieved negative hcv rna at the end of treatment, defined according to genotype (24 weeks for hcv genotypes 2/3 and 48 weeks for genotypes 1/4).
Description

HCV RNA Negative | Hepatitis C virus genotype

Data type

boolean

Alias
UMLS CUI [1,1]
C1868902
UMLS CUI [1,2]
C1513916
UMLS CUI [2]
C1148363
participants with diagnosed chronic hepatitis c (chc) and hcv genotype 1, 2, 3 or 4.
Description

Hepatitis C, Chronic | Hepatitis C virus genotype

Data type

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2]
C1148363
participants older than 18 years, regardless of gender or race.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the participant has received treatment for chc in the past (not treatment-naive).
Description

Therapeutic procedure Chronic Hepatitis C

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0524910
the participant has received treatment in the context of a clinical trial in the participating site.
Description

Therapeutic procedure | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C0087111
UMLS CUI [2]
C2348568
the participant has been diagnosed with a concomitant infection e.g. with hepatitis b or hiv
Description

Communicable Diseases | Hepatitis B | HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019693
the participant has de-compensated liver disease or belongs to a special population, such as liver transplant, hemophilia, severe pre-existing psychiatric disorder, auto-immune disease, thalassaemia.
Description

Decompensated liver disease | Transplantation of liver | Hemophilia | Mental disorders Pre-existing Severe | Autoimmune Diseases | Thalassemia

Data type

boolean

Alias
UMLS CUI [1]
C4075847
UMLS CUI [2]
C0023911
UMLS CUI [3]
C0684275
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C2347662
UMLS CUI [4,3]
C0205082
UMLS CUI [5]
C0004364
UMLS CUI [6]
C0039730
the participant has positive hcv rna at the end of treatment.
Description

HCV RNA Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C1868902
UMLS CUI [1,2]
C1514241
pregnant women or women intending to bear children or sexual partners of women wishing to bear children and for a 7-month period after the end of treatment, as indicated in the smpc of rebetol.
Description

Pregnancy | Pregnancy, Planned | Partner in relationship Planned Pregnancy | Rebetol

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3,1]
C0682323
UMLS CUI [3,2]
C0032992
UMLS CUI [4]
C1170576
the participant is not eligible on grounds of contra-indications, special warnings, particular population and/or the section on pregnancy and lactation of the smpc.
Description

Medical contraindication | Cautionary Warning | Population Specific | Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C1301624
UMLS CUI [2]
C0871599
UMLS CUI [3,1]
C1257890
UMLS CUI [3,2]
C0205369
UMLS CUI [4]
C0032961
UMLS CUI [5]
C0006147
the participant has interrupted treatment for any reason.
Description

Therapy interrupted

Data type

boolean

Alias
UMLS CUI [1]
C1710384
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Similar models

Eligibility Hepatitis C, Chronic NCT00724464

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Combined Modality Therapy Started | peginterferon alfa-2b | Ribavirin
Item
participants who have already begun summary of product characteristics (smpc)-based combination treatment with pegylated interferon alpha-2b and ribavirin, prior to the site initiation date.
boolean
C0009429 (UMLS CUI [1,1])
C1272689 (UMLS CUI [1,2])
C0796545 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
Combined Modality Therapy Previous | peginterferon alfa-2b | Ribavirin
Item
participants who have been receiving combination treatment with pegylated interferon alpha-2b and ribavirin for at least 6 months before enrollment.
boolean
C0009429 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0796545 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
HCV RNA Negative | Hepatitis C virus genotype
Item
participants who have achieved negative hcv rna at the end of treatment, defined according to genotype (24 weeks for hcv genotypes 2/3 and 48 weeks for genotypes 1/4).
boolean
C1868902 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C1148363 (UMLS CUI [2])
Hepatitis C, Chronic | Hepatitis C virus genotype
Item
participants with diagnosed chronic hepatitis c (chc) and hcv genotype 1, 2, 3 or 4.
boolean
C0524910 (UMLS CUI [1])
C1148363 (UMLS CUI [2])
Age
Item
participants older than 18 years, regardless of gender or race.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure Chronic Hepatitis C
Item
the participant has received treatment for chc in the past (not treatment-naive).
boolean
C0087111 (UMLS CUI [1,1])
C0524910 (UMLS CUI [1,2])
Therapeutic procedure | Study Subject Participation Status
Item
the participant has received treatment in the context of a clinical trial in the participating site.
boolean
C0087111 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
Communicable Diseases | Hepatitis B | HIV Infection
Item
the participant has been diagnosed with a concomitant infection e.g. with hepatitis b or hiv
boolean
C0009450 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Decompensated liver disease | Transplantation of liver | Hemophilia | Mental disorders Pre-existing Severe | Autoimmune Diseases | Thalassemia
Item
the participant has de-compensated liver disease or belongs to a special population, such as liver transplant, hemophilia, severe pre-existing psychiatric disorder, auto-immune disease, thalassaemia.
boolean
C4075847 (UMLS CUI [1])
C0023911 (UMLS CUI [2])
C0684275 (UMLS CUI [3])
C0004936 (UMLS CUI [4,1])
C2347662 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
C0004364 (UMLS CUI [5])
C0039730 (UMLS CUI [6])
HCV RNA Positive
Item
the participant has positive hcv rna at the end of treatment.
boolean
C1868902 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Pregnancy | Pregnancy, Planned | Partner in relationship Planned Pregnancy | Rebetol
Item
pregnant women or women intending to bear children or sexual partners of women wishing to bear children and for a 7-month period after the end of treatment, as indicated in the smpc of rebetol.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0682323 (UMLS CUI [3,1])
C0032992 (UMLS CUI [3,2])
C1170576 (UMLS CUI [4])
Medical contraindication | Cautionary Warning | Population Specific | Pregnancy | Breast Feeding
Item
the participant is not eligible on grounds of contra-indications, special warnings, particular population and/or the section on pregnancy and lactation of the smpc.
boolean
C1301624 (UMLS CUI [1])
C0871599 (UMLS CUI [2])
C1257890 (UMLS CUI [3,1])
C0205369 (UMLS CUI [3,2])
C0032961 (UMLS CUI [4])
C0006147 (UMLS CUI [5])
Therapy interrupted
Item
the participant has interrupted treatment for any reason.
boolean
C1710384 (UMLS CUI [1])
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