ID

40902

Beskrivning

A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01330316

Länk

https://clinicaltrials.gov/show/NCT01330316

Nyckelord

Versioner (1)
  1. 2020-06-01 2020-06-01 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

1 juni 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01330316

Engelsk

Eligibility Hepatitis C NCT01330316

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
chronic hepatitis c infection of gt-1 in patients who failed prior treatment with pegifn and rbv in the 1220.7, 1220.30 and 1220.47 trials of the bi 201335 phase iii program.
Beskrivning

Chronic Hepatitis C Genotype determination | PEGINTERFERON/RIBAVIRIN failed | Clinical Trials Specified

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1285573
UMLS CUI [2,1]
C1875630
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C0008976
UMLS CUI [3,2]
C0205369
1. patients from trials 1220.7, 1220.30 and 1220.47 of bi 201335 who have failed treatment with pegifn/rbv in the placebo groups due to protocol-defined criteria of treatment failure (i.e. either non-response on treatment or relapse after end of treatment [eot]).
Beskrivning

PEGINTERFERON/RIBAVIRIN failed | Clinical Trials Specified | Unresponsive to Treatment | Relapse Post Treatment completed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1875630
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
UMLS CUI [3]
C0205269
UMLS CUI [4,1]
C0035020
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C0580352
2. patients must have received at least 4 weeks of assigned trial medication and been compliant with all study procedures.
Beskrivning

Investigational New Drugs Study Protocol | Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0525058
3. female patients:
Beskrivning

Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
with documented hysterectomy,
Beskrivning

Hysterectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0020699
who have had both ovaries removed,
Beskrivning

Bilateral oophorectomy

Datatyp

boolean

Alias
UMLS CUI [1]
C0278321
with documented tubal ligation,
Beskrivning

Tubal Ligation

Datatyp

boolean

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

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
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 rbv 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 rbv.
Beskrivning

Childbearing Potential Serum pregnancy test negative | Childbearing Potential Sexually active Contraceptive methods | Childbearing Potential Sexually active Female Condom | Breast Feeding Absent

Datatyp

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]
C3831118
UMLS CUI [3,2]
C0241028
UMLS CUI [3,3]
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, intra-uterine device and cervical cap.
Beskrivning

Contraceptive methods | Contraceptive Agents Containing Ethinyl Estradiol | Vaginal contraceptive diaphragm | Vaginal Spermicides | Intrauterine Devices | CERVICAL CAP

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2,1]
C0009871
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0015011
UMLS CUI [3]
C0042241
UMLS CUI [4]
C0087145
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0493327
male patients:
Beskrivning

Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
who are documented to be sterile, or
Beskrivning

Male sterilization

Datatyp

boolean

Alias
UMLS CUI [1]
C0024559
who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) 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. 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 must 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).
Beskrivning

Partner Pregnancy Absent | Condoms, Male | Partner Childbearing Potential Contraceptive methods | Partner Childbearing Potential Pregnancy Tests Monthly

Datatyp

boolean

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

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. evidence of acute or chronic liver disease due to causes other than chronic hcv infection. incidental steatosis diagnosed by biopsy is not an exclusion criteria.
Beskrivning

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

Datatyp

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
2. hiv co-infection
Beskrivning

HIV coinfection

Datatyp

boolean

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

Hepatitis B | Hepatitis B Surface Antigens Present

Datatyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C0150312
4. 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)
Beskrivning

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

Datatyp

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
5. active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months
Beskrivning

Alcohol abuse | Illicit medication use | Exception Marihuana

Datatyp

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0281875
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0024808
6. 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
Beskrivning

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

Datatyp

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]
C0439801
UMLS CUI [3,3]
C2348568
7. usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study.
Beskrivning

Investigational New Drugs | Investigational New Drugs Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C1301732
8. received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to screening. 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.
Beskrivning

Systemic antiviral treatment | Hematopoietic Growth Factors | Immunomodulatory therapy

Datatyp

boolean

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

Silymarin | Glycyrrhizic Acid | shosaiko-to

Datatyp

boolean

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

Hypersensitivity Ingredient Investigational New Drugs Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1550600
UMLS CUI [1,3]
C0013230
UMLS CUI [1,4]
C2348563
11. 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).
Beskrivning

Alpha fetoprotein measurement

Datatyp

boolean

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

Eligibility Criteria Additional | Relationship Restriction PEGINTERFERON | Relationship Restriction Ribavirin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C0443288
UMLS CUI [2,3]
C0982327
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0443288
UMLS CUI [3,3]
C0035525
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Similar models

Eligibility Hepatitis C NCT01330316

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Chronic Hepatitis C Genotype determination | PEGINTERFERON/RIBAVIRIN failed | Clinical Trials Specified
Item
chronic hepatitis c infection of gt-1 in patients who failed prior treatment with pegifn and rbv in the 1220.7, 1220.30 and 1220.47 trials of the bi 201335 phase iii program.
boolean
C0524910 (UMLS CUI [1,1])
C1285573 (UMLS CUI [1,2])
C1875630 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0008976 (UMLS CUI [3,1])
C0205369 (UMLS CUI [3,2])
PEGINTERFERON/RIBAVIRIN failed | Clinical Trials Specified | Unresponsive to Treatment | Relapse Post Treatment completed
Item
1. patients from trials 1220.7, 1220.30 and 1220.47 of bi 201335 who have failed treatment with pegifn/rbv in the placebo groups due to protocol-defined criteria of treatment failure (i.e. either non-response on treatment or relapse after end of treatment [eot]).
boolean
C1875630 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C0205269 (UMLS CUI [3])
C0035020 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C0580352 (UMLS CUI [4,3])
Investigational New Drugs Study Protocol | Protocol Compliance
Item
2. patients must have received at least 4 weeks of assigned trial medication and been compliant with all study procedures.
boolean
C0013230 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Gender
Item
3. female patients:
boolean
C0079399 (UMLS CUI [1])
Hysterectomy
Item
with documented hysterectomy,
boolean
C0020699 (UMLS CUI [1])
Bilateral oophorectomy
Item
who have had both ovaries removed,
boolean
C0278321 (UMLS CUI [1])
Tubal Ligation
Item
with documented tubal ligation,
boolean
C0520483 (UMLS CUI [1])
Postmenopausal state
Item
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 | Childbearing Potential Sexually active Female Condom | Breast Feeding Absent
Item
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 rbv 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 rbv.
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])
C3831118 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0221829 (UMLS CUI [3,3])
C0006147 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Contraceptive methods | Contraceptive Agents Containing Ethinyl Estradiol | Vaginal contraceptive diaphragm | Vaginal Spermicides | Intrauterine Devices | CERVICAL CAP
Item
medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance, intra-uterine device and cervical cap.
boolean
C0700589 (UMLS CUI [1])
C0009871 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0015011 (UMLS CUI [2,3])
C0042241 (UMLS CUI [3])
C0087145 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0493327 (UMLS CUI [6])
Gender
Item
male patients:
boolean
C0079399 (UMLS CUI [1])
Male sterilization
Item
who are documented to be sterile, or
boolean
C0024559 (UMLS CUI [1])
Partner Pregnancy Absent | Condoms, Male | Partner Childbearing Potential Contraceptive methods | Partner Childbearing Potential Pregnancy Tests Monthly
Item
who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) 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. 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 must 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])
C0009653 (UMLS CUI [2])
C0682323 (UMLS CUI [3,1])
C3831118 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C0682323 (UMLS CUI [4,1])
C3831118 (UMLS CUI [4,2])
C0032976 (UMLS CUI [4,3])
C0332177 (UMLS CUI [4,4])
Informed Consent
Item
4. signed informed consent form prior to trial participation.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Liver disease | Chronic liver disease | Etiology Except Chronic Hepatitis C
Item
1. evidence of acute or chronic liver disease due to causes other than chronic hcv infection. incidental steatosis diagnosed by biopsy is not an exclusion criteria.
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
2. hiv co-infection
boolean
C4062778 (UMLS CUI [1])
Hepatitis B | Hepatitis B Surface Antigens Present
Item
3. 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
4. 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 | Illicit medication use | Exception Marihuana
Item
5. active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months
boolean
C0085762 (UMLS CUI [1])
C0281875 (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 Limiting Study Subject Participation Status
Item
6. 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])
C0439801 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
Investigational New Drugs | Investigational New Drugs Planned
Item
7. 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])
C0013230 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Systemic antiviral treatment | Hematopoietic Growth Factors | Immunomodulatory therapy
Item
8. received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to screening. 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
9. received silymarin (milk thistle), glycyrrhizin, or sho-saiko-to (sst) within 28 days prior to enrolment and throughout the treatment phase of this trial.
boolean
C0037135 (UMLS CUI [1])
C0061751 (UMLS CUI [2])
C1138004 (UMLS CUI [3])
Hypersensitivity Ingredient Investigational New Drugs Study Protocol
Item
10. known hypersensitivity to any ingredient of the study drugs.
boolean
C0020517 (UMLS CUI [1,1])
C1550600 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
Alpha fetoprotein measurement
Item
11. 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])
Eligibility Criteria Additional | Relationship Restriction PEGINTERFERON | Relationship Restriction Ribavirin
Item
other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are not listed here.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0439849 (UMLS CUI [2,1])
C0443288 (UMLS CUI [2,2])
C0982327 (UMLS CUI [2,3])
C0439849 (UMLS CUI [3,1])
C0443288 (UMLS CUI [3,2])
C0035525 (UMLS CUI [3,3])
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