ID

17514

Description

Merimepodib (MMPD) in Triple Combination for the Treatment of Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00088504

Link

https://clinicaltrials.gov/show/NCT00088504

Keywords

Versions (1)
  1. 9/20/16 9/20/16 -
Uploaded on

September 20, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00088504

English

Eligibility Hepatitis C NCT00088504

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the following is a summary of the inclusion and exclusion criteria for the merimepodib triple combination (metro) trial. there are also additional criteria, which will be reviewed with you by the staff at the clinical study site, to make sure you are eligible for the study. some of the criteria are dependent on the results of blood tests and other tests that will be done at the clinical site.
Description

MerimepodibTriple Combination Trial | Hematologic Tests | Laboratory Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C1259637
UMLS CUI [1,2]
C0205174
UMLS CUI [1,3]
C0205195
UMLS CUI [1,4]
C0008976
UMLS CUI [2]
C0018941
UMLS CUI [3]
C0022885
if you are not sure whether you meet these criteria, please call the clinical study site nearest you, and they can help you figure out if you might be eligible for the study:
Description

criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
you must have been diagnosed with hepatitis c.
Description

Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019196
you must have been treated with pegylated interferon (brand names are pegasys® or peg-intron®) and ribavirin (brand names rebetol® or copegus®), for at least 12 weeks. however, you cannot have received more than one course of this combination therapy.
Description

pegylated interferon alfa | Pegasys | Pegintron | Ribavirin | Rebetol | Copegus

Data type

boolean

Alias
UMLS CUI [1]
C0907160
UMLS CUI [2]
C1176430
UMLS CUI [3]
C1527737
UMLS CUI [4]
C0035525
UMLS CUI [5]
C1170576
UMLS CUI [6]
C1170183
you must have been a "non-responder" to this treatment, meaning that the virus levels in your blood were always detectable. if you responded to the treatment and then the virus became detectable again (called a "relapse"), you would not be eligible.
Description

Unresponsive to Treatment | Recurrent disease

Data type

boolean

Alias
UMLS CUI [1]
C0205269
UMLS CUI [2]
C0277556
you must not have used illegal drugs, or have a history of significant alcohol use, within the last year before you start the study.
Description

Illicit drug use | Alcohol consumption Significant

Data type

boolean

Alias
UMLS CUI [1]
C0281875
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0750502
pegasys® and copegus® are not recommended for people with some illnesses. you should be in good health in general, with no illnesses that would prevent you from using pegasys® and copegus®. if you do not know whether you have any illness or conditions that would prevent you from using these medications, the study doctor or nurse will review your medical history with you to determine this.
Description

General health good | Pegasys | Copegus

Data type

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2]
C1176430
UMLS CUI [3]
C1170183
if you are a woman who can have children, you must be willing to use two effective methods of birth control during the study and for 6 months after the last dose of the medication. you will have monthly pregnancy tests during this time to make sure you do not become pregnant (this is recommended for anyone taking ribavirin, even when they are not in a clinical study.).
Description

Gender Contraceptive methods | Pregnancy Tests Frequency | Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0032976
UMLS CUI [2,2]
C0376249
UMLS CUI [3]
C0035525
if you are a male, your female partner must not be pregnant, and you both must be willing to use birth control during the time you are in the study, and for 6 months after the last dose of the medication (this is recommended for anyone taking ribavirin, even when they are not in a clinical study.).
Description

Gender Contraceptive methods | Pregnancy | Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0035525
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Similar models

Eligibility Hepatitis C NCT00088504

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
MerimepodibTriple Combination Trial | Hematologic Tests | Laboratory Procedures
Item
the following is a summary of the inclusion and exclusion criteria for the merimepodib triple combination (metro) trial. there are also additional criteria, which will be reviewed with you by the staff at the clinical study site, to make sure you are eligible for the study. some of the criteria are dependent on the results of blood tests and other tests that will be done at the clinical site.
boolean
C1259637 (UMLS CUI [1,1])
C0205174 (UMLS CUI [1,2])
C0205195 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0018941 (UMLS CUI [2])
C0022885 (UMLS CUI [3])
criteria Fulfill
Item
if you are not sure whether you meet these criteria, please call the clinical study site nearest you, and they can help you figure out if you might be eligible for the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Hepatitis C
Item
you must have been diagnosed with hepatitis c.
boolean
C0019196 (UMLS CUI [1])
pegylated interferon alfa | Pegasys | Pegintron | Ribavirin | Rebetol | Copegus
Item
you must have been treated with pegylated interferon (brand names are pegasys® or peg-intron®) and ribavirin (brand names rebetol® or copegus®), for at least 12 weeks. however, you cannot have received more than one course of this combination therapy.
boolean
C0907160 (UMLS CUI [1])
C1176430 (UMLS CUI [2])
C1527737 (UMLS CUI [3])
C0035525 (UMLS CUI [4])
C1170576 (UMLS CUI [5])
C1170183 (UMLS CUI [6])
Unresponsive to Treatment | Recurrent disease
Item
you must have been a "non-responder" to this treatment, meaning that the virus levels in your blood were always detectable. if you responded to the treatment and then the virus became detectable again (called a "relapse"), you would not be eligible.
boolean
C0205269 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
Illicit drug use | Alcohol consumption Significant
Item
you must not have used illegal drugs, or have a history of significant alcohol use, within the last year before you start the study.
boolean
C0281875 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
General health good | Pegasys | Copegus
Item
pegasys® and copegus® are not recommended for people with some illnesses. you should be in good health in general, with no illnesses that would prevent you from using pegasys® and copegus®. if you do not know whether you have any illness or conditions that would prevent you from using these medications, the study doctor or nurse will review your medical history with you to determine this.
boolean
C1277245 (UMLS CUI [1])
C1176430 (UMLS CUI [2])
C1170183 (UMLS CUI [3])
Gender Contraceptive methods | Pregnancy Tests Frequency | Ribavirin
Item
if you are a woman who can have children, you must be willing to use two effective methods of birth control during the study and for 6 months after the last dose of the medication. you will have monthly pregnancy tests during this time to make sure you do not become pregnant (this is recommended for anyone taking ribavirin, even when they are not in a clinical study.).
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0032976 (UMLS CUI [2,1])
C0376249 (UMLS CUI [2,2])
C0035525 (UMLS CUI [3])
Gender Contraceptive methods | Pregnancy | Ribavirin
Item
if you are a male, your female partner must not be pregnant, and you both must be willing to use birth control during the time you are in the study, and for 6 months after the last dose of the medication (this is recommended for anyone taking ribavirin, even when they are not in a clinical study.).
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
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