ID

40836

Beschreibung

Lonafarnib for Chronic Hepatitis D; ODM derived from: https://clinicaltrials.gov/show/NCT01495585

Link

https://clinicaltrials.gov/show/NCT01495585

Stichworte

Versionen (1)
  1. 21.05.20 21.05.20 -
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See clinicaltrials.gov

Hochgeladen am

21. Mai 2020

DOI

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Eligibility Hepatitis D NCT01495585

Englisch

Eligibility Hepatitis D NCT01495585

1 Formulare  
Criteria
Beschreibung

Criteria

1. age 18 years or above, male or female.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. serum alanine or aspartate aminotransferase activities above the upper limit of normal (alt > 41 or ast > 31 u/l) on an average of three determinations taken during the previous 6 months. the mean of the three determinations will be defined as baseline levels.
Beschreibung

Alanine aminotransferase increased | Aspartate aminotransferase increased | Average Determination Quantity

Datentyp

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
UMLS CUI [3,1]
C1510992
UMLS CUI [3,2]
C1148554
UMLS CUI [3,3]
C1265611
3. presence of anti-hdv in serum.
Beschreibung

Hepatitis D antibody Serum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0312635
UMLS CUI [1,2]
C0229671
4. evidence of chronic hepatitis on liver biopsy done within the previous 12 months with a necroinflammatory score in histology activity index of at least 5 (out of a maximum of 18) and at least 1 for hepatic fibrosis (out of a maximum of 6).
Beschreibung

Chronic Hepatitis Biopsy of liver | Necroinflammatory activity score | Knodell Fibrosis Score | Fibrosis, Liver

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019189
UMLS CUI [1,2]
C0193388
UMLS CUI [2]
C1954431
UMLS CUI [3]
C3898641
UMLS CUI [4]
C0239946
5. presence of hdv antigen in liver tissue or hdv rna in serum.
Beschreibung

Hepatitis delta Antigens Liver parenchyma | Hepatitis D virus RNA Serum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0057317
UMLS CUI [1,2]
C0736268
UMLS CUI [2,1]
C0486926
UMLS CUI [2,2]
C0229671
6. written informed consent.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. decompensated liver disease, defined by bilirubin > 4mg/dl, albumin < 3.0 gm/dl, prothrombin time > 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. laboratory abnormalities that are not thought to be due to liver disease may not necessarily require exclusion. patients with alt levels greater than 1000 u/l (> 25 times uln) will not be enrolled but may be followed until three determinations are below this level.
Beschreibung

Decompensated Liver Disease | Serum total bilirubin measurement | Albumin measurement | Prolonged prothrombin time | Bleeding esophageal varices | Ascites | Hepatic Encephalopathy | Alanine aminotransferase measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0745744
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]
C0201836
2. pregnancy or inability to practice adequate contraception, in women of childbearing potential or in spouses of such women. adequate contraception is defined as vasectomy in men, tubal ligation in women, or use of two barrier methods such as condoms and spermicide combination, birth control pills, an intrauterine device, depo-provera, or norplant.
Beschreibung

Pregnancy | Childbearing Potential Contraceptive methods Unable | Spouse Contraceptive methods Unable | Vasectomy | Tubal Ligation | Barrier Contraception Quantity | Condoms | Spermatocidal Agents | Contraceptives, Oral | Intrauterine Devices | Depo-Provera | Norplant

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0162409
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1299582
UMLS CUI [4]
C0042387
UMLS CUI [5]
C0520483
UMLS CUI [6,1]
C0004764
UMLS CUI [6,2]
C1265611
UMLS CUI [7]
C0677582
UMLS CUI [8]
C0037862
UMLS CUI [9]
C0009905
UMLS CUI [10]
C0021900
UMLS CUI [11]
C0699700
UMLS CUI [12]
C1145675
3. significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (egfr < 50 ml/min), organ transplantation, serious psychiatric disease or depression (only if felt to be at high risk by the nih psychiatric consultation service), and active coronary artery disease.
Beschreibung

Systemic disease | Illness Major | Exception Liver disease | Congestive heart failure | Kidney Failure | Estimated Glomerular Filtration Rate | Organ Transplantation | Serious mental illness | Depressive disorder Serious | Coronary Artery Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0442893
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205164
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0023895
UMLS CUI [4]
C0018802
UMLS CUI [5]
C0035078
UMLS CUI [6]
C3811844
UMLS CUI [7]
C0029216
UMLS CUI [8]
C3841614
UMLS CUI [9,1]
C0011581
UMLS CUI [9,2]
C0205404
UMLS CUI [10]
C1956346
4. systemic immunosuppressive therapy within the previous 2 months.
Beschreibung

Therapeutic immunosuppression Systemic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C0205373
5. evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, wilson disease, alcoholic liver disease, nonalcoholic steatohepatitis (but not steatosis), hemochromatosis, or alpha-1-antitrypsin deficiency).
Beschreibung

Liver disease In addition to Viral hepatitis | Autoimmune liver disease | Primary biliary cirrhosis | Primary sclerosing cholangitis | Wilson's disease | Alcoholic Liver Diseases | Nonalcoholic Steatohepatitis | Hemochromatosis | alpha 1-Antitrypsin Deficiency

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0042721
UMLS CUI [2]
C0400936
UMLS CUI [3]
C0008312
UMLS CUI [4]
C0566602
UMLS CUI [5]
C0019202
UMLS CUI [6]
C0023896
UMLS CUI [7]
C3241937
UMLS CUI [8]
C0018995
UMLS CUI [9]
C0221757
6. active substance abuse, such as alcohol, inhaled or injection drugs within the previous year.
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
7. evidence of hepatocellular carcinoma.
Beschreibung

Liver carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C2239176
8. evidence of concurrent hepatitis c infection with positive serum hcv rna.
Beschreibung

Hepatitis C | Hepatitis C RNA positive Serum

Datentyp

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C0855842
UMLS CUI [2,2]
C0229671
9. any experimental therapy apart from pegylated interferon within 6 months prior to enrollment.
Beschreibung

Therapy, Investigational | Exception PEGINTERFERON

Datentyp

boolean

Alias
UMLS CUI [1]
C0949266
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0982327
10. diagnosis of malignancy in the five years prior to the enrollment with exception granted to superficial dermatologic malignancies.
Beschreibung

Malignant Neoplasms | Exception Malignant neoplasm of skin Superficial

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007114
UMLS CUI [2,3]
C0205124
11. evidence of hiv co-infection; hiv (omega) antibody positivity on serum testing.
Beschreibung

HIV coinfection | HIV Seropositivity

Datentyp

boolean

Alias
UMLS CUI [1]
C4062778
UMLS CUI [2]
C0019699
12. concurrent usage of statins as these drugs inhibit mevalonate synthesis which reduces protein prenylation.
Beschreibung

Statins

Datentyp

boolean

Alias
UMLS CUI [1]
C0360714
13. concurrent usage of moderate and strong cyp3a inhibitors and inducers.
Beschreibung

CYP3A Inhibitors Moderate | CYP3A Inhibitors Strong | CYP3A Inducers Moderate | CYP3A Inducers Strong

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3850056
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C3850056
UMLS CUI [2,2]
C0442821
UMLS CUI [3,1]
C3850044
UMLS CUI [3,2]
C0205081
UMLS CUI [4,1]
C3850044
UMLS CUI [4,2]
C0442821
14. inability to understand or sign informed consent.
Beschreibung

Informed Consent Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
15. any other condition, which in the opinion of the investigators would impede the patient s participation or compliance in the study.
Beschreibung

Condition Interferes with Study Subject Participation Status | Condition Interferes with Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
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Ähnliche Modelle

Eligibility Hepatitis D NCT01495585

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Age
Item
1. age 18 years or above, male or female.
boolean
C0001779 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased | Average Determination Quantity
Item
2. serum alanine or aspartate aminotransferase activities above the upper limit of normal (alt > 41 or ast > 31 u/l) on an average of three determinations taken during the previous 6 months. the mean of the three determinations will be defined as baseline levels.
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C1510992 (UMLS CUI [3,1])
C1148554 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Hepatitis D antibody Serum
Item
3. presence of anti-hdv in serum.
boolean
C0312635 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
Chronic Hepatitis Biopsy of liver | Necroinflammatory activity score | Knodell Fibrosis Score | Fibrosis, Liver
Item
4. evidence of chronic hepatitis on liver biopsy done within the previous 12 months with a necroinflammatory score in histology activity index of at least 5 (out of a maximum of 18) and at least 1 for hepatic fibrosis (out of a maximum of 6).
boolean
C0019189 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C1954431 (UMLS CUI [2])
C3898641 (UMLS CUI [3])
C0239946 (UMLS CUI [4])
Hepatitis delta Antigens Liver parenchyma | Hepatitis D virus RNA Serum
Item
5. presence of hdv antigen in liver tissue or hdv rna in serum.
boolean
C0057317 (UMLS CUI [1,1])
C0736268 (UMLS CUI [1,2])
C0486926 (UMLS CUI [2,1])
C0229671 (UMLS CUI [2,2])
Informed Consent
Item
6. written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Decompensated Liver Disease | Serum total bilirubin measurement | Albumin measurement | Prolonged prothrombin time | Bleeding esophageal varices | Ascites | Hepatic Encephalopathy | Alanine aminotransferase measurement
Item
1. decompensated liver disease, defined by bilirubin > 4mg/dl, albumin < 3.0 gm/dl, prothrombin time > 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy. laboratory abnormalities that are not thought to be due to liver disease may not necessarily require exclusion. patients with alt levels greater than 1000 u/l (> 25 times uln) will not be enrolled but may be followed until three determinations are below this level.
boolean
C0745744 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201838 (UMLS CUI [3])
C2673577 (UMLS CUI [4])
C0155789 (UMLS CUI [5])
C0003962 (UMLS CUI [6])
C0019151 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
Pregnancy | Childbearing Potential Contraceptive methods Unable | Spouse Contraceptive methods Unable | Vasectomy | Tubal Ligation | Barrier Contraception Quantity | Condoms | Spermatocidal Agents | Contraceptives, Oral | Intrauterine Devices | Depo-Provera | Norplant
Item
2. pregnancy or inability to practice adequate contraception, in women of childbearing potential or in spouses of such women. adequate contraception is defined as vasectomy in men, tubal ligation in women, or use of two barrier methods such as condoms and spermicide combination, birth control pills, an intrauterine device, depo-provera, or norplant.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0162409 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
C0042387 (UMLS CUI [4])
C0520483 (UMLS CUI [5])
C0004764 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0677582 (UMLS CUI [7])
C0037862 (UMLS CUI [8])
C0009905 (UMLS CUI [9])
C0021900 (UMLS CUI [10])
C0699700 (UMLS CUI [11])
C1145675 (UMLS CUI [12])
Systemic disease | Illness Major | Exception Liver disease | Congestive heart failure | Kidney Failure | Estimated Glomerular Filtration Rate | Organ Transplantation | Serious mental illness | Depressive disorder Serious | Coronary Artery Disease
Item
3. significant systemic or major illnesses other than liver disease, including, but not limited to, congestive heart failure, renal failure (egfr < 50 ml/min), organ transplantation, serious psychiatric disease or depression (only if felt to be at high risk by the nih psychiatric consultation service), and active coronary artery disease.
boolean
C0442893 (UMLS CUI [1])
C0221423 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0023895 (UMLS CUI [3,2])
C0018802 (UMLS CUI [4])
C0035078 (UMLS CUI [5])
C3811844 (UMLS CUI [6])
C0029216 (UMLS CUI [7])
C3841614 (UMLS CUI [8])
C0011581 (UMLS CUI [9,1])
C0205404 (UMLS CUI [9,2])
C1956346 (UMLS CUI [10])
Therapeutic immunosuppression Systemic
Item
4. systemic immunosuppressive therapy within the previous 2 months.
boolean
C0021079 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Liver disease In addition to Viral hepatitis | Autoimmune liver disease | Primary biliary cirrhosis | Primary sclerosing cholangitis | Wilson's disease | Alcoholic Liver Diseases | Nonalcoholic Steatohepatitis | Hemochromatosis | alpha 1-Antitrypsin Deficiency
Item
5. evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, wilson disease, alcoholic liver disease, nonalcoholic steatohepatitis (but not steatosis), hemochromatosis, or alpha-1-antitrypsin deficiency).
boolean
C0023895 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0042721 (UMLS CUI [1,3])
C0400936 (UMLS CUI [2])
C0008312 (UMLS CUI [3])
C0566602 (UMLS CUI [4])
C0019202 (UMLS CUI [5])
C0023896 (UMLS CUI [6])
C3241937 (UMLS CUI [7])
C0018995 (UMLS CUI [8])
C0221757 (UMLS CUI [9])
Substance Use Disorders
Item
6. active substance abuse, such as alcohol, inhaled or injection drugs within the previous year.
boolean
C0038586 (UMLS CUI [1])
Liver carcinoma
Item
7. evidence of hepatocellular carcinoma.
boolean
C2239176 (UMLS CUI [1])
Hepatitis C | Hepatitis C RNA positive Serum
Item
8. evidence of concurrent hepatitis c infection with positive serum hcv rna.
boolean
C0019196 (UMLS CUI [1])
C0855842 (UMLS CUI [2,1])
C0229671 (UMLS CUI [2,2])
Therapy, Investigational | Exception PEGINTERFERON
Item
9. any experimental therapy apart from pegylated interferon within 6 months prior to enrollment.
boolean
C0949266 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0982327 (UMLS CUI [2,2])
Malignant Neoplasms | Exception Malignant neoplasm of skin Superficial
Item
10. diagnosis of malignancy in the five years prior to the enrollment with exception granted to superficial dermatologic malignancies.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007114 (UMLS CUI [2,2])
C0205124 (UMLS CUI [2,3])
HIV coinfection | HIV Seropositivity
Item
11. evidence of hiv co-infection; hiv (omega) antibody positivity on serum testing.
boolean
C4062778 (UMLS CUI [1])
C0019699 (UMLS CUI [2])
Statins
Item
12. concurrent usage of statins as these drugs inhibit mevalonate synthesis which reduces protein prenylation.
boolean
C0360714 (UMLS CUI [1])
CYP3A Inhibitors Moderate | CYP3A Inhibitors Strong | CYP3A Inducers Moderate | CYP3A Inducers Strong
Item
13. concurrent usage of moderate and strong cyp3a inhibitors and inducers.
boolean
C3850056 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C3850056 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C3850044 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C3850044 (UMLS CUI [4,1])
C0442821 (UMLS CUI [4,2])
Informed Consent Unable
Item
14. inability to understand or sign informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Protocol Compliance
Item
15. any other condition, which in the opinion of the investigators would impede the patient s participation or compliance in the study.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
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