Chronic hepatitis C
Conditions
Interventions
PEG-IFN alfa-2a monotherapy in the patients who undetectable HCV-RNA at week 4
PEG-IFNalfa-2a/Ribavirin combination therapy in the patients who undetectable HCV-RNA at week 4
PEG-IFN alfa-2a once a
Sponsors
Hyogo College Of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Existence of previous treatment (interferon therapy including a Ribavirin combined therapy) is not asked. 2.Genotype1,more than HCV-RNA 100KIU/ml 3.Baseline of the following clinical laboratory test result / before a medication start -- the patient who filled all WBC count : more than3,000/mm3 neutrophil count: more than 1,500/mm3 PLT count:more than 90,000/mm3 Hemoglobin content :more than12g/dl 4.The patient by sufficient understanding top after being given ( sufficient ) in participation of an exam, and a document -- the patient by whom the consent by the free intention of the person himself/herself was got
Exclusion criteria
Exclusion criteria: 1.A pregnant woman, the woman who may have become pregnant, or the woman under breastfeeding 2.The patient who has an anamnesis of hypersensitivity to the ingredient or other nucleoside analogs of this agent (acyclovir, ganciclovir, Bidarabin, etc.) 3.A patient with cardiac disease (myocardial infarction, heart failure, abnormal heart rhythm etc.) with difficult control 4.The patient of abnormal hemoglobin diseases (sarasemia, drepanocytic anemia, etc.) 5.The patient to whom the following renal dysfunction has chronic renal failure or a creatinine clearance by 50mL/min 6.A patient with the patient in serious mental disease states, such as serious depression, suicide ideation, or a suicide attempt, or its anamnesis 7.A critical impaired liver function patient 8.The patient of autoimmune hepatitis 9.The patient who is prescribing Syousaikotou 10.The chronic liver disease patient of others, such as autoimmune hepatitis and alcoholic hepatitis 11.The patient who has an anamnesis of hypersensitivity to the ingredient or other interferon tablets of this agent 12.The patient who has an anamnesis of hypersensitivity to biological preparation, such as a vaccine 13.The patient of liver cirrhosis, hepatic insufficiency, and cancer of liver 14.The patient who meets at least one standard of the following clinical laboratory test result / before a medication start before treatment WBC count Less than 3,000/mm3 neutrophil count Less than 1,500/mm3 PLT count Less than 90,000/mm3 Hemoglobin content Less than 12g/dl 15.In addition, the patient whom the examination doctor in attendance judged that the participation to an exam is unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Virological response:SVR HCVRNA negativity of 24 weeks of end of treatment | — |
Countries
Japan
Contacts
Public ContactTeruhisa Yamamoto
Hyogo College Of Medicine Division of Hepatobiliary and Pancreatic Diseases Department of Internal Medicine
Outcome results
None listed