ID

39638

Beschreibung

Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 1); ODM derived from: https://clinicaltrials.gov/show/NCT01343888

Link

https://clinicaltrials.gov/show/NCT01343888

Stichworte

Versionen (1)
  1. 07.02.20 07.02.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. Februar 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01343888

Englisch

Eligibility Hepatitis C NCT01343888

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. chronic hepatitis c infection, diagnosed by positive anti-hcv antibodies and detected hcv rna at screening in addition to:
Beschreibung

Hepatitis C, Chronic | Hepatitis C antibody positive | Hepatitis C RNA positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0855842
1. positive anti-hcv antibodies or detected hcv rna at least 6 months prior to screening; or,
Beschreibung

Hepatitis C antibody positive Duration | Hepatitis C RNA positive Duration

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0281863
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0855842
UMLS CUI [2,2]
C0449238
2. liver biopsy consistent with chronic hcv infection.
Beschreibung

Biopsy of liver Consistent with Chronic Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0524910
2. hcv genotype 1 infection confirmed by genotypic testing at screening.
Beschreibung

Hepatitis C Genotype determination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1533728
3. therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral /
Beschreibung

Therapy naive Interferon | Therapy naive PEGINTERFERON | Therapy naive Ribavirin | Therapy naive Antiviral Agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C3652465
UMLS CUI [2,1]
C0919936
UMLS CUI [2,2]
C0982327
UMLS CUI [3,1]
C0919936
UMLS CUI [3,2]
C0035525
UMLS CUI [4,1]
C0919936
UMLS CUI [4,2]
C0003451
immunomodulatory drug for acute or chronic hcv infection.
Beschreibung

Biological Response Modifiers Hepatitis C | Biological Response Modifiers Chronic Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005525
UMLS CUI [1,2]
C0019196
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0524910
4. hcv rna = 1,000 iu/ml at screening
Beschreibung

Hepatitis C virus RNA assay

Datentyp

boolean

Alias
UMLS CUI [1]
C1272251
5. documentation of a liver biopsy within 3 years or fibroscan within 6 months prior to randomization.
Beschreibung

Biopsy of liver | Fibroscan

Datentyp

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2]
C4522043
note: if cirrhosis has been previously demonstrated on a biopsy, then biopsies obtained more than 3 years before randomization need not be repeated. biopsies may be waived for patients who would be placed at risk from the procedure. inability to do a liver biopsy in patients at risk for the procedure should not exclude such patients from a trial.
Beschreibung

Liver Cirrhosis Biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0005558
6. age 18 to 70 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
7. female patients:
Beschreibung

Patients Gender

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0079399
1. with documented hysterectomy,
Beschreibung

Hysterectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0020699
2. who have had both ovaries removed,
Beschreibung

Both ovaries Removed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0227898
UMLS CUI [1,2]
C0849355
3. with documented tubal ligation,
Beschreibung

Tubal Ligation

Datentyp

boolean

Alias
UMLS CUI [1]
C0520483
4. who are post-menopausal with last menstrual period at least 12 months prior to screening, or
Beschreibung

Postmenopausal state

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
5. of childbearing potential with a negative serum pregnancy test at screening and day 1, that, if sexually active, agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin in addition to the consistent and correct use of a condom. patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin.
Beschreibung

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Sexually active Contraceptive methods | Use of Female Condoms | Breast Feeding Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0241028
UMLS CUI [2,3]
C0700589
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0221829
UMLS CUI [4,1]
C0006147
UMLS CUI [4,2]
C0332197
medically accepted methods of contraception for females in this trial are ethinyl estradiol containing contraceptives, diaphragm with spermicide substance and intra-uterine device.
Beschreibung

Contraceptive Agents Containing Ethinyl Estradiol | Vaginal contraceptive diaphragm | Vaginal Spermicide | Intrauterine Device

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009871
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0015011
UMLS CUI [2]
C0042241
UMLS CUI [3]
C0087145
UMLS CUI [4]
C0021900
male patients:
Beschreibung

Patients Gender

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0079399
1. who are documented to be sterile, or
Beschreibung

Male sterilization

Datentyp

boolean

Alias
UMLS CUI [1]
C0024559
2. who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin. it is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase. female partners of childbearing potential should perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor).
Beschreibung

Partner Pregnancy Absent | Use of Male Condom | Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy Tests Monthly

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0682323
UMLS CUI [1,2]
C0032961
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0009653
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0032976
UMLS CUI [4,3]
C0332177
8. signed informed consent form prior to trial participation
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. hcv infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
Beschreibung

Hepatitis C Genotype Mixed | Hepatitis C virus genotype determination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1148363
UMLS CUI [1,3]
C0205430
UMLS CUI [2]
C1533728
2. evidence of acute or chronic liver disease due to causes other than chronic hcv infection. incidental steatosis diagnosed by biopsy is not an exclusion criterion.
Beschreibung

Liver disease | Chronic liver disease | Etiology Except Chronic Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0341439
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0332300
UMLS CUI [3,3]
C0524910
3. hiv co-infection
Beschreibung

HIV coinfection

Datentyp

boolean

Alias
UMLS CUI [1]
C4062778
4. hepatitis b virus (hbv) infection based on presence of hbs-ag
Beschreibung

Hepatitis B | Hepatitis B Surface Antigens Present

Datentyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C0150312
5. active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
Beschreibung

Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1522326
6. active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months
Beschreibung

Alcohol abuse | DRUG ABUSE ILLICIT | Exception Marihuana

Datentyp

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0743253
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0024808
7. a condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patients ability to participate in this study
Beschreibung

Condition Study Subject Participation Status At risk | Condition Influence Research results | Condition Study Subject Participation Status Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0439801
8. usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study.
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
9. received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to randomization. patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza a infection, may be screened.
Beschreibung

Systemic antiviral treatment | Hematopoietic Growth Factors | Immunomodulatory therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0854610
UMLS CUI [2]
C0079490
UMLS CUI [3]
C1963758
10. received silymarin (milk thistle), glycyrrhizin, or sho-saiko-to (sst) within 28 days prior to randomization and throughout the treatment phase of this trial.
Beschreibung

Silymarin | Glycyrrhizic Acid | shosaiko-to

Datentyp

boolean

Alias
UMLS CUI [1]
C0037135
UMLS CUI [2]
C0061751
UMLS CUI [3]
C1138004
11. known hypersensitivity to any ingredient of the study drugs.
Beschreibung

Hypersensitivity Investigational New Drug Ingredient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1550600
12. alpha fetoprotein value > 100 ng/ml at screening; if > 20 ng/ml and = 100 ng/ml, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, ct scan, or mri) within last 6 months prior to randomization (visit 2).
Beschreibung

Alpha one fetoprotein measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0201539
other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are not listed here.
Beschreibung

Omission Exclusion Criteria Relationship PEGINTERFERON | Omission Exclusion Criteria Relationship Ribavirin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3845736
UMLS CUI [1,2]
C0680251
UMLS CUI [1,3]
C0439849
UMLS CUI [1,4]
C0982327
UMLS CUI [2,1]
C3845736
UMLS CUI [2,2]
C0680251
UMLS CUI [2,3]
C0439849
UMLS CUI [2,4]
C0035525
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Ähnliche Modelle

Eligibility Hepatitis C NCT01343888

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C, Chronic | Hepatitis C antibody positive | Hepatitis C RNA positive
Item
1. chronic hepatitis c infection, diagnosed by positive anti-hcv antibodies and detected hcv rna at screening in addition to:
boolean
C0524910 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0855842 (UMLS CUI [3])
Hepatitis C antibody positive Duration | Hepatitis C RNA positive Duration
Item
1. positive anti-hcv antibodies or detected hcv rna at least 6 months prior to screening; or,
boolean
C0281863 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0855842 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Biopsy of liver Consistent with Chronic Hepatitis C
Item
2. liver biopsy consistent with chronic hcv infection.
boolean
C0193388 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
Hepatitis C Genotype determination
Item
2. hcv genotype 1 infection confirmed by genotypic testing at screening.
boolean
C0019196 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
Therapy naive Interferon | Therapy naive PEGINTERFERON | Therapy naive Ribavirin | Therapy naive Antiviral Agents
Item
3. therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral /
boolean
C0919936 (UMLS CUI [1,1])
C3652465 (UMLS CUI [1,2])
C0919936 (UMLS CUI [2,1])
C0982327 (UMLS CUI [2,2])
C0919936 (UMLS CUI [3,1])
C0035525 (UMLS CUI [3,2])
C0919936 (UMLS CUI [4,1])
C0003451 (UMLS CUI [4,2])
Biological Response Modifiers Hepatitis C | Biological Response Modifiers Chronic Hepatitis C
Item
immunomodulatory drug for acute or chronic hcv infection.
boolean
C0005525 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0524910 (UMLS CUI [2,2])
Hepatitis C virus RNA assay
Item
4. hcv rna = 1,000 iu/ml at screening
boolean
C1272251 (UMLS CUI [1])
Biopsy of liver | Fibroscan
Item
5. documentation of a liver biopsy within 3 years or fibroscan within 6 months prior to randomization.
boolean
C0193388 (UMLS CUI [1])
C4522043 (UMLS CUI [2])
Liver Cirrhosis Biopsy
Item
note: if cirrhosis has been previously demonstrated on a biopsy, then biopsies obtained more than 3 years before randomization need not be repeated. biopsies may be waived for patients who would be placed at risk from the procedure. inability to do a liver biopsy in patients at risk for the procedure should not exclude such patients from a trial.
boolean
C0023890 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
Age
Item
6. age 18 to 70 years
boolean
C0001779 (UMLS CUI [1])
Patients Gender
Item
7. female patients:
boolean
C0030705 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
Hysterectomy
Item
1. with documented hysterectomy,
boolean
C0020699 (UMLS CUI [1])
Both ovaries Removed
Item
2. who have had both ovaries removed,
boolean
C0227898 (UMLS CUI [1,1])
C0849355 (UMLS CUI [1,2])
Tubal Ligation
Item
3. with documented tubal ligation,
boolean
C0520483 (UMLS CUI [1])
Postmenopausal state
Item
4. who are post-menopausal with last menstrual period at least 12 months prior to screening, or
boolean
C0232970 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Sexually active Contraceptive methods | Use of Female Condoms | Breast Feeding Absent
Item
5. of childbearing potential with a negative serum pregnancy test at screening and day 1, that, if sexually active, agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin in addition to the consistent and correct use of a condom. patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of ribavirin.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C1524063 (UMLS CUI [3,1])
C0221829 (UMLS CUI [3,2])
C0006147 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Contraceptive Agents Containing Ethinyl Estradiol | Vaginal contraceptive diaphragm | Vaginal Spermicide | Intrauterine Device
Item
medically accepted methods of contraception for females in this trial are ethinyl estradiol containing contraceptives, diaphragm with spermicide substance and intra-uterine device.
boolean
C0009871 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0015011 (UMLS CUI [1,3])
C0042241 (UMLS CUI [2])
C0087145 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
Patients Gender
Item
male patients:
boolean
C0030705 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
Male sterilization
Item
1. who are documented to be sterile, or
boolean
C0024559 (UMLS CUI [1])
Partner Pregnancy Absent | Use of Male Condom | Childbearing Potential Contraceptive methods | Childbearing Potential Pregnancy Tests Monthly
Item
2. who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin. it is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase. female partners of childbearing potential should perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor).
boolean
C0682323 (UMLS CUI [1,1])
C0032961 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C1524063 (UMLS CUI [2,1])
C0009653 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0032976 (UMLS CUI [4,2])
C0332177 (UMLS CUI [4,3])
Informed Consent
Item
8. signed informed consent form prior to trial participation
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hepatitis C Genotype Mixed | Hepatitis C virus genotype determination
Item
1. hcv infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
boolean
C0019196 (UMLS CUI [1,1])
C1148363 (UMLS CUI [1,2])
C0205430 (UMLS CUI [1,3])
C1533728 (UMLS CUI [2])
Liver disease | Chronic liver disease | Etiology Except Chronic Hepatitis C
Item
2. evidence of acute or chronic liver disease due to causes other than chronic hcv infection. incidental steatosis diagnosed by biopsy is not an exclusion criterion.
boolean
C0023895 (UMLS CUI [1])
C0341439 (UMLS CUI [2])
C0015127 (UMLS CUI [3,1])
C0332300 (UMLS CUI [3,2])
C0524910 (UMLS CUI [3,3])
HIV coinfection
Item
3. hiv co-infection
boolean
C4062778 (UMLS CUI [1])
Hepatitis B | Hepatitis B Surface Antigens Present
Item
4. hepatitis b virus (hbv) infection based on presence of hbs-ag
boolean
C0019163 (UMLS CUI [1])
C0019168 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
5. active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Alcohol abuse | DRUG ABUSE ILLICIT | Exception Marihuana
Item
6. active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months
boolean
C0085762 (UMLS CUI [1])
C0743253 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0024808 (UMLS CUI [3,2])
Condition Study Subject Participation Status At risk | Condition Influence Research results | Condition Study Subject Participation Status Limited
Item
7. a condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patients ability to participate in this study
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
Investigational New Drugs
Item
8. usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study.
boolean
C0013230 (UMLS CUI [1])
Systemic antiviral treatment | Hematopoietic Growth Factors | Immunomodulatory therapy
Item
9. received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to randomization. patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza a infection, may be screened.
boolean
C0854610 (UMLS CUI [1])
C0079490 (UMLS CUI [2])
C1963758 (UMLS CUI [3])
Silymarin | Glycyrrhizic Acid | shosaiko-to
Item
10. received silymarin (milk thistle), glycyrrhizin, or sho-saiko-to (sst) within 28 days prior to randomization and throughout the treatment phase of this trial.
boolean
C0037135 (UMLS CUI [1])
C0061751 (UMLS CUI [2])
C1138004 (UMLS CUI [3])
Hypersensitivity Investigational New Drug Ingredient
Item
11. known hypersensitivity to any ingredient of the study drugs.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
Alpha one fetoprotein measurement
Item
12. alpha fetoprotein value > 100 ng/ml at screening; if > 20 ng/ml and = 100 ng/ml, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, ct scan, or mri) within last 6 months prior to randomization (visit 2).
boolean
C0201539 (UMLS CUI [1])
Omission Exclusion Criteria Relationship PEGINTERFERON | Omission Exclusion Criteria Relationship Ribavirin
Item
other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are not listed here.
boolean
C3845736 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0982327 (UMLS CUI [1,4])
C3845736 (UMLS CUI [2,1])
C0680251 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0035525 (UMLS CUI [2,4])
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