Age | Informed Consent
Item
1. men and women age 18 or older with the capacity to give written informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Chronic hepatitis D infection Compensated | Hepatitis D antibody Serum
Item
2. patients with compensated chronic hdv infection as indicated by presence of anti-hdv in serum.
boolean
C2074980 (UMLS CUI [1,1])
C0205432 (UMLS CUI [1,2])
C0312635 (UMLS CUI [2,1])
C0229671 (UMLS CUI [2,2])
Biopsy of liver | Knodell Fibrosis Score
Item
3. liver biopsy should be performed within one-year of study screening and graded using the knodell scoring system.
boolean
C0193388 (UMLS CUI [1])
C3898641 (UMLS CUI [2])
Hepatitis delta Antigens Liver parenchyma | Hepatitis D virus RNA Serum
Item
4. 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])
Hepatitis B Virus Replication
Item
5. active hbv replication will not exclude patients.
boolean
C0019169 (UMLS CUI [1,1])
C0042774 (UMLS CUI [1,2])
Prior Therapy | Interferon-alpha | PEGINTERFERON
Item
6. previous therapy with standard alpha-interferon or peginterferon will not exclude patients.
boolean
C1514463 (UMLS CUI [1])
C0002199 (UMLS CUI [2])
C0982327 (UMLS CUI [3])
Therapy naive Hepatitis B Virus | Antiviral Therapy Hepatitis B Virus
Item
7. patients who are hbv therapy-naïve or who previously received hbv antiviral therapy will be eligible. patients currently taking hbv antiviral therapy will e considered on a case basis.
boolean
C0919936 (UMLS CUI [1,1])
C0019169 (UMLS CUI [1,2])
C0280274 (UMLS CUI [2,1])
C0019169 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods Quantity | Gender Partner Contraceptive methods Quantity
Item
8. female subjects of reproductive potential and female partners of male subjects should be on two reliable forms of contraception from the start of the study until 60 days from the end of ebp921 dosing.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
Neuropsychiatric syndrome Severe
Item
1. severe neuropsychiatric disorders
boolean
C3203509 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Metabolic Disease | Hematological Disease | Lung disease | Myocardial Ischemia | Heart Disease | Heart Disease Unstable | Gastrointestinal Disease | Nervous system disorder | Kidney Disease | Urologic Disease | Endocrine System Disease | Disorder of eye | Retinal Disease Severe | Disease Immune-mediated
Item
2. history or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune-mediated disease
boolean
C0025517 (UMLS CUI [1])
C0018939 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0151744 (UMLS CUI [4])
C0018799 (UMLS CUI [5])
C0018799 (UMLS CUI [6,1])
C0443343 (UMLS CUI [6,2])
C0017178 (UMLS CUI [7])
C0027765 (UMLS CUI [8])
C0022658 (UMLS CUI [9])
C0042075 (UMLS CUI [10])
C0014130 (UMLS CUI [11])
C0015397 (UMLS CUI [12])
C0035309 (UMLS CUI [13,1])
C0205082 (UMLS CUI [13,2])
C0012634 (UMLS CUI [14,1])
C4330477 (UMLS CUI [14,2])
Pregnancy | Breast Feeding | Contraceptive methods Unable
Item
3. pregnant or breast-feeding patients or the inability to practice adequate contraception during the conduct of the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Autoimmune Diseases | Immunologic Deficiency Syndromes | Lupus Erythematosus | Sarcoidosis | Celiac Disease | HIV antibody positive | AIDS
Item
4. underlying autoimmune/immune-deficiency disease (e.g., lupus, sarcoidosis, celiac disease, hiv antibody positive, aids)
boolean
C0004364 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C0409974 (UMLS CUI [3])
C0036202 (UMLS CUI [4])
C0007570 (UMLS CUI [5])
C0920548 (UMLS CUI [6])
C0001175 (UMLS CUI [7])
Chronic diarrhea Duration
Item
5. chronic (> 4 weeks duration) diarrhea
boolean
C0401151 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Body Weight
Item
6. body weight > 128 kg and < 40 kg
boolean
C0005910 (UMLS CUI [1])
Liver Cirrhosis Uncompensated
Item
7. uncompensated cirrhosis
boolean
C0023890 (UMLS CUI [1,1])
C0205433 (UMLS CUI [1,2])
Absolute neutrophil count
Item
8. absolute neutrophil count less than 1500 per cubic millimeter
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
9. platelet count less than 90,000 per cubic millimeter
boolean
C0032181 (UMLS CUI [1])
Hepatitis C | Serum Hepatitis C RNA positive
Item
10. evidence of concurrent hcv infection with positive serum hcvrna
boolean
C0019196 (UMLS CUI [1])
C0229671 (UMLS CUI [2,1])
C0855842 (UMLS CUI [2,2])
Liver carcinoma
Item
11. evidence of hepatocellular carcinoma
boolean
C2239176 (UMLS CUI [1])
Substance Use Disorders
Item
12. active substance abuse (alcohol, inhaled or injected drugs) within the past 12 months
boolean
C0038586 (UMLS CUI [1])
Malignant Neoplasms | Exception Malignant neoplasm of skin Superficial
Item
13. diagnosis of malignancy in the previous five years excluding superficial dermatologic malignancies
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007114 (UMLS CUI [2,2])
C0205124 (UMLS CUI [2,3])
Therapy, Investigational
Item
14. any experimental therapy in the previous 6 months prior to enrollment.
boolean
C0949266 (UMLS CUI [1])
Multi-Drug Resistance HBV | Interferon therapy
Item
16. patients with a history of multiple drug resistant hbv 17. patients receiving interferon therapy for any reason.
boolean
C0242640 (UMLS CUI [1,1])
C0019169 (UMLS CUI [1,2])
C0279030 (UMLS CUI [2])