chronic hepatitis C and liver cirrhosis
Conditions
Interventions
To investigate the optimal dosage of TPO To administer the optimal dosage of TPO for 24 weeks
Sponsors
University of Tsukuba
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Participant who gave written informed consent (2) Outpatient (3) Chronic hepatitis C and liver cirrhosis patient with liver dysfunction under SVR after treatment with PEG-INF plus Ribavirin (4) Chronic hepatitis C and liver cirrhosis patient who had no response to PEG-INF plus Ribavirin and who passed 4 weeks after the treatment (5) Chronic hepatitis C and liver cirrhosis patient who can't receive PEG-INF treatment due to thrombopenia (6) Platelet count is 30 to 70 thousands/microl. (7) Serum albumin is 2.5 to 4.0g/dl. (8) Chronic hepatitis C and liver cirrhosis patient with liver dysfunction in previous half year (9) Child-Pugh score is 8 or under
Exclusion criteria
Exclusion criteria: (1) Patient with acute hepatitis (2) Patient with severe liver dysfunction whose serum liver function test is 5 fold higher than normal range, especially, AST or ALT is 2 fold higher than normal range (3) HIV patient (4) Patient with shunt from portal vein to inferior vena cava (5) Serum total bilirubin concentration is more than 3.0 mg/dl (6) Past history of severe stroke or severe heart disease (7) Bone marrow transplantation recipient or patients with immunodeficiency (8) Patient with IgA or other plasma protein deficiency (9) Patient with severe pulmonary, renal, gastroenterology, hematology or psycho-neurologic disease (10) Serum HbA1c concentration is more than 8.0 (NGSP) (11) Patient with hepatocellular carcinoma or another malignancy (12) Woman with pregnancy or willing to get pregnant (13) Patient who received platelet transfusion in previous 2 weeks (14) Patient who are administered albumin preparation in previous 6 months (15) Past history of splenectomy or partial splenic embolization (16) Past history of drug allergies (17) Past history of thromboembolism (18) Patient whose doctor determined as inadequate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum albumin concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Child-Pugh Score, platelet count, hyarulonic acid, prothrombin time, serum bilirubin, serum cholinesterase | — |
Countries
Japan
Contacts
Public ContactNobuhiro Ohkohchi
Faculty of Medicine, University of Tsukuba Department of Surgery
Outcome results
None listed