ID

29742

Description

Viral Kinetics and Liver Gene Expression in Response to Ribavirin and Peginterferon Therapy of Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00718172

Link

https://clinicaltrials.gov/show/NCT00718172

Keywords

Versions (1)
  1. 4/17/18 4/17/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 17, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT00718172

English

Eligibility Hepatitis C, Chronic NCT00718172

1 forms  
Criteria
Description

Criteria

age 18 years or above, male or female
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
presence of hcv rna (with or without anti-hcv) in serum at levels of at least 10,000 iu/ml.
Description

Hepatitis C virus RNA assay | Anti HCV | Anti HCV Absent

Data type

boolean

Alias
UMLS CUI [1]
C1272251
UMLS CUI [2]
C0166049
UMLS CUI [3,1]
C0166049
UMLS CUI [3,2]
C0332197
willingness to undergo liver biopsy before or 6 hours after an initial injection of peginterferon.
Description

Biopsy of liver | PEGINTERFERON Injection

Data type

boolean

Alias
UMLS CUI [1]
C0193388
UMLS CUI [2,1]
C0982327
UMLS CUI [2,2]
C1828121
written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous adequate treatment with any form of type i interferon (standard alpha interferon, peginterferon, beta interferon). adequate treatment is considered at least 12 weeks of therapy.
Description

Interferon Type I | Interferon-alpha | PEGINTERFERON | Interferon-beta

Data type

boolean

Alias
UMLS CUI [1]
C0021743
UMLS CUI [2]
C0002199
UMLS CUI [3]
C0982327
UMLS CUI [4]
C0015980
other antiviral therapy within the last 6 months.
Description

Antiviral Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0280274
if cirrhosis is present, decompensated liver disease, as marked by bilirubin greater than 4 mg percent, albumin less than 3.0 gm percent, prothrombin time greater than 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy.
Description

Liver Cirrhosis | Decompensated liver disease | Serum total bilirubin measurement | Albumin measurement | Prolonged prothrombin time | Bleeding esophageal varices | Ascites | Hepatic Encephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C4075847
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201838
UMLS CUI [5]
C2673577
UMLS CUI [6]
C0155789
UMLS CUI [7]
C0003962
UMLS CUI [8]
C0019151
serum alt or ast levels greater than 1000 micro/l (greater than 25 times uln). such patients will not be enrolled but may be followed until three consecutive determinations are below this level.
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
pregnancy or current breastfeeding. in women of child bearing potential or in spouses of such women, inability to practice adequate contraception, defined as vasectomy in men, tubal ligation in women, or use of condoms and spermicide, or birth control pills, or an intrauterine device until 6 months after the end of treatment with ribavirin given the potential for teratogenicity.
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unable | Spouse Childbearing Potential Contraceptive methods Unable | Vasectomy | Tubal Ligation | Condoms | Spermatocidal Agents | Contraceptives, Oral | Intrauterine Devices | Ribavirin | Teratogenesis

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1299582
UMLS CUI [4,1]
C0162409
UMLS CUI [4,2]
C3831118
UMLS CUI [4,3]
C0700589
UMLS CUI [4,4]
C1299582
UMLS CUI [5]
C0042387
UMLS CUI [6]
C0520483
UMLS CUI [7]
C0677582
UMLS CUI [8]
C0037862
UMLS CUI [9]
C0009905
UMLS CUI [10]
C0021900
UMLS CUI [11]
C0035525
UMLS CUI [12]
C0232910
significant systemic or major illnesses including congestive heart failure, organ transplantation, serious psychiatric disease or depression, human immunodeficiency virus (hiv) infection, and angina pectoris.
Description

Systemic disease | Illness Major | Congestive heart failure | Organ Transplantation | Mental disorders Serious | Depressive disorder Serious | HIV Infection | Angina Pectoris

Data type

boolean

Alias
UMLS CUI [1]
C0442893
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205164
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0029216
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0205404
UMLS CUI [6,1]
C0011581
UMLS CUI [6,2]
C0205404
UMLS CUI [7]
C0019693
UMLS CUI [8]
C0002962
pre-existing anemia (hematocrit less than 33 percent) or known history of hemolytic anemia. in patients in groups c and d, liver biopsy will not be performed if hemoglobin levels fall to below 11 g/dl during ribavirin monotherapy. epopoetin alfa or darbopoietin alfa therapy will be available to achieve an adequate hematocrit if clinically indicated for patients in all groups.
Description

Anemia Pre-existing | Hematocrit level | Anemia, Hemolytic | Biopsy of liver | Hemoglobin measurement | Ribavirin | Epoetin Alfa | darbepoetin alfa

Data type

boolean

Alias
UMLS CUI [1,1]
C0002871
UMLS CUI [1,2]
C2347662
UMLS CUI [2]
C0518014
UMLS CUI [3]
C0002878
UMLS CUI [4]
C0193388
UMLS CUI [5]
C0518015
UMLS CUI [6]
C0035525
UMLS CUI [7]
C0357126
UMLS CUI [8]
C0937950
immunosuppressive therapy with either corticosteroids (more than 5 mg of prednisone daily on a chronic basis) or major immunosuppressive agents (such as azathioprine or 6-mercaptopurine). patients receiving a short-course of corticosteroids for acute allergic reactions or asthma or chronic obstructive pulmonary disease exacerbations (less than 2 weeks of therapy) will be eligible for the study after 4 weeks off therapy.
Description

Therapeutic immunosuppression | Adrenal Cortex Hormones | Prednisone U/day chronic | Immunosuppressive Agents Major | Azathioprine | 6-mercaptopurine

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C0001617
UMLS CUI [3,1]
C0032952
UMLS CUI [3,2]
C0456683
UMLS CUI [3,3]
C0205191
UMLS CUI [4,1]
C0021081
UMLS CUI [4,2]
C0205164
UMLS CUI [5]
C0004482
UMLS CUI [6]
C0000618
evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, wilson's disease, alcoholic liver disease, hemochromatosis, alpha 1 antitrypsin deficiency). patients with concomitant non-alcoholic steatohepatitis but no other form of chronic liver disease will not be excluded from this study.
Description

Liver diseases | Viral hepatitis | Autoimmune liver disease | Hepatolenticular Degeneration | Alcoholic Liver Diseases | Hemochromatosis | alpha 1-Antitrypsin Deficiency | Nonalcoholic Steatohepatitis eligible

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0042721
UMLS CUI [3]
C0400936
UMLS CUI [4]
C0019202
UMLS CUI [5]
C0023896
UMLS CUI [6]
C0018995
UMLS CUI [7]
C0221757
UMLS CUI [8,1]
C3241937
UMLS CUI [8,2]
C1548635
evidence of coronary artery disease or cerebral vascular disease, including abnormalities on exercise stress testing in patients with defined risk factors who will be screened for evidence of underlying coronary artery disease.
Description

Coronary Artery Disease | Cerebrovascular Disorders | EXERCISE STRESS TEST ABNORMAL | Risk factors

Data type

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0007820
UMLS CUI [3]
C0743633
UMLS CUI [4]
C0035648
active substance abuse, such as alcohol, inhaled or injection drugs within the previous year.
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
evidence of hepatocellular carcinoma; either alpha-fetoprotein (afp) levels greater than 200 ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer.
Description

Liver carcinoma | Alpha one fetoprotein measurement | Mass Suggestive of Malignant neoplasm of liver Ultrasonography | Mass Suggestive of Malignant neoplasm of liver Imaging study

Data type

boolean

Alias
UMLS CUI [1]
C2239176
UMLS CUI [2]
C0201539
UMLS CUI [3,1]
C0577559
UMLS CUI [3,2]
C0332299
UMLS CUI [3,3]
C0345904
UMLS CUI [3,4]
C0041618
UMLS CUI [4,1]
C0577559
UMLS CUI [4,2]
C0332299
UMLS CUI [4,3]
C0345904
UMLS CUI [4,4]
C1881134
clinical gout.
Description

Gout

Data type

boolean

Alias
UMLS CUI [1]
C0018099
active, serious autoimmune disease such as systemic lupus erythematosis, ulcerative colitis, crohn s disease or rheumatoid arthritis that in the opinion of the investigators might be exacerbated by therapy with alpha interferon.
Description

Autoimmune Disease Serious | Lupus Erythematosus, Systemic | Ulcerative Colitis | Crohn Disease | Rheumatoid Arthritis | Worsening Possible caused by Interferon-alpha

Data type

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0024141
UMLS CUI [3]
C0009324
UMLS CUI [4]
C0010346
UMLS CUI [5]
C0003873
UMLS CUI [6,1]
C0332271
UMLS CUI [6,2]
C0332149
UMLS CUI [6,3]
C0015127
UMLS CUI [6,4]
C0002199
these exclusion criteria are considered the standard relative contraindications to peginterferon and ribavirin therapy.
Description

Medical contraindication PEGINTERFERON | Medical contraindication Ribavirin

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0982327
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0035525
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Similar models

Eligibility Hepatitis C, Chronic NCT00718172

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Age
Item
age 18 years or above, male or female
boolean
C0001779 (UMLS CUI [1])
Hepatitis C virus RNA assay | Anti HCV | Anti HCV Absent
Item
presence of hcv rna (with or without anti-hcv) in serum at levels of at least 10,000 iu/ml.
boolean
C1272251 (UMLS CUI [1])
C0166049 (UMLS CUI [2])
C0166049 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Biopsy of liver | PEGINTERFERON Injection
Item
willingness to undergo liver biopsy before or 6 hours after an initial injection of peginterferon.
boolean
C0193388 (UMLS CUI [1])
C0982327 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
Informed Consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Interferon Type I | Interferon-alpha | PEGINTERFERON | Interferon-beta
Item
previous adequate treatment with any form of type i interferon (standard alpha interferon, peginterferon, beta interferon). adequate treatment is considered at least 12 weeks of therapy.
boolean
C0021743 (UMLS CUI [1])
C0002199 (UMLS CUI [2])
C0982327 (UMLS CUI [3])
C0015980 (UMLS CUI [4])
Antiviral Therapy
Item
other antiviral therapy within the last 6 months.
boolean
C0280274 (UMLS CUI [1])
Liver Cirrhosis | Decompensated liver disease | Serum total bilirubin measurement | Albumin measurement | Prolonged prothrombin time | Bleeding esophageal varices | Ascites | Hepatic Encephalopathy
Item
if cirrhosis is present, decompensated liver disease, as marked by bilirubin greater than 4 mg percent, albumin less than 3.0 gm percent, prothrombin time greater than 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy.
boolean
C0023890 (UMLS CUI [1])
C4075847 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201838 (UMLS CUI [4])
C2673577 (UMLS CUI [5])
C0155789 (UMLS CUI [6])
C0003962 (UMLS CUI [7])
C0019151 (UMLS CUI [8])
Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
serum alt or ast levels greater than 1000 micro/l (greater than 25 times uln). such patients will not be enrolled but may be followed until three consecutive determinations are below this level.
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Unable | Spouse Childbearing Potential Contraceptive methods Unable | Vasectomy | Tubal Ligation | Condoms | Spermatocidal Agents | Contraceptives, Oral | Intrauterine Devices | Ribavirin | Teratogenesis
Item
pregnancy or current breastfeeding. in women of child bearing potential or in spouses of such women, inability to practice adequate contraception, defined as vasectomy in men, tubal ligation in women, or use of condoms and spermicide, or birth control pills, or an intrauterine device until 6 months after the end of treatment with ribavirin given the potential for teratogenicity.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0162409 (UMLS CUI [4,1])
C3831118 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
C1299582 (UMLS CUI [4,4])
C0042387 (UMLS CUI [5])
C0520483 (UMLS CUI [6])
C0677582 (UMLS CUI [7])
C0037862 (UMLS CUI [8])
C0009905 (UMLS CUI [9])
C0021900 (UMLS CUI [10])
C0035525 (UMLS CUI [11])
C0232910 (UMLS CUI [12])
Systemic disease | Illness Major | Congestive heart failure | Organ Transplantation | Mental disorders Serious | Depressive disorder Serious | HIV Infection | Angina Pectoris
Item
significant systemic or major illnesses including congestive heart failure, organ transplantation, serious psychiatric disease or depression, human immunodeficiency virus (hiv) infection, and angina pectoris.
boolean
C0442893 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3])
C0029216 (UMLS CUI [4])
C0004936 (UMLS CUI [5,1])
C0205404 (UMLS CUI [5,2])
C0011581 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C0019693 (UMLS CUI [7])
C0002962 (UMLS CUI [8])
Anemia Pre-existing | Hematocrit level | Anemia, Hemolytic | Biopsy of liver | Hemoglobin measurement | Ribavirin | Epoetin Alfa | darbepoetin alfa
Item
pre-existing anemia (hematocrit less than 33 percent) or known history of hemolytic anemia. in patients in groups c and d, liver biopsy will not be performed if hemoglobin levels fall to below 11 g/dl during ribavirin monotherapy. epopoetin alfa or darbopoietin alfa therapy will be available to achieve an adequate hematocrit if clinically indicated for patients in all groups.
boolean
C0002871 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0518014 (UMLS CUI [2])
C0002878 (UMLS CUI [3])
C0193388 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
C0035525 (UMLS CUI [6])
C0357126 (UMLS CUI [7])
C0937950 (UMLS CUI [8])
Therapeutic immunosuppression | Adrenal Cortex Hormones | Prednisone U/day chronic | Immunosuppressive Agents Major | Azathioprine | 6-mercaptopurine
Item
immunosuppressive therapy with either corticosteroids (more than 5 mg of prednisone daily on a chronic basis) or major immunosuppressive agents (such as azathioprine or 6-mercaptopurine). patients receiving a short-course of corticosteroids for acute allergic reactions or asthma or chronic obstructive pulmonary disease exacerbations (less than 2 weeks of therapy) will be eligible for the study after 4 weeks off therapy.
boolean
C0021079 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0032952 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0205191 (UMLS CUI [3,3])
C0021081 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0004482 (UMLS CUI [5])
C0000618 (UMLS CUI [6])
Liver diseases | Viral hepatitis | Autoimmune liver disease | Hepatolenticular Degeneration | Alcoholic Liver Diseases | Hemochromatosis | alpha 1-Antitrypsin Deficiency | Nonalcoholic Steatohepatitis eligible
Item
evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, wilson's disease, alcoholic liver disease, hemochromatosis, alpha 1 antitrypsin deficiency). patients with concomitant non-alcoholic steatohepatitis but no other form of chronic liver disease will not be excluded from this study.
boolean
C0023895 (UMLS CUI [1])
C0042721 (UMLS CUI [2])
C0400936 (UMLS CUI [3])
C0019202 (UMLS CUI [4])
C0023896 (UMLS CUI [5])
C0018995 (UMLS CUI [6])
C0221757 (UMLS CUI [7])
C3241937 (UMLS CUI [8,1])
C1548635 (UMLS CUI [8,2])
Coronary Artery Disease | Cerebrovascular Disorders | EXERCISE STRESS TEST ABNORMAL | Risk factors
Item
evidence of coronary artery disease or cerebral vascular disease, including abnormalities on exercise stress testing in patients with defined risk factors who will be screened for evidence of underlying coronary artery disease.
boolean
C1956346 (UMLS CUI [1])
C0007820 (UMLS CUI [2])
C0743633 (UMLS CUI [3])
C0035648 (UMLS CUI [4])
Substance Use Disorders
Item
active substance abuse, such as alcohol, inhaled or injection drugs within the previous year.
boolean
C0038586 (UMLS CUI [1])
Liver carcinoma | Alpha one fetoprotein measurement | Mass Suggestive of Malignant neoplasm of liver Ultrasonography | Mass Suggestive of Malignant neoplasm of liver Imaging study
Item
evidence of hepatocellular carcinoma; either alpha-fetoprotein (afp) levels greater than 200 ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer.
boolean
C2239176 (UMLS CUI [1])
C0201539 (UMLS CUI [2])
C0577559 (UMLS CUI [3,1])
C0332299 (UMLS CUI [3,2])
C0345904 (UMLS CUI [3,3])
C0041618 (UMLS CUI [3,4])
C0577559 (UMLS CUI [4,1])
C0332299 (UMLS CUI [4,2])
C0345904 (UMLS CUI [4,3])
C1881134 (UMLS CUI [4,4])
Gout
Item
clinical gout.
boolean
C0018099 (UMLS CUI [1])
Autoimmune Disease Serious | Lupus Erythematosus, Systemic | Ulcerative Colitis | Crohn Disease | Rheumatoid Arthritis | Worsening Possible caused by Interferon-alpha
Item
active, serious autoimmune disease such as systemic lupus erythematosis, ulcerative colitis, crohn s disease or rheumatoid arthritis that in the opinion of the investigators might be exacerbated by therapy with alpha interferon.
boolean
C0004364 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0024141 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
C0010346 (UMLS CUI [4])
C0003873 (UMLS CUI [5])
C0332271 (UMLS CUI [6,1])
C0332149 (UMLS CUI [6,2])
C0015127 (UMLS CUI [6,3])
C0002199 (UMLS CUI [6,4])
Medical contraindication PEGINTERFERON | Medical contraindication Ribavirin
Item
these exclusion criteria are considered the standard relative contraindications to peginterferon and ribavirin therapy.
boolean
C1301624 (UMLS CUI [1,1])
C0982327 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0035525 (UMLS CUI [2,2])
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