hepatitis C
Conditions
Interventions
Vitamin D3 (Alfacalcidol) is administered to the patient with osteoporosis in addition to standard treatment of hepatitis C.
Sponsors
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patient diagnosed as chronic hepatitis C or compensated liver cirrhosis due to HCV 2.Genotype 1 type with high viral load (HCV-RNA 100KIU or more) in chronic hepatitis C 3.No the treatment history are asked. 4.Osteoporosis or the bone mass decreased patient. 3.Patient who obtains agreement for participation in present study.
Exclusion criteria
Exclusion criteria: 1.Pregnant woman or woman who has possibility of pregnancy or woman while suckling 2.Patient who has previous history of hypersensitivity for element of ribavirin or other nucleosides analog (aciclovir, ganciclovir, and vidarabine, etc.) 3.Patient who has heart disease difficult to control (cardiac infarction, cardiac failure, and arrhythmia, etc.) 4.Patient with abnormal haemoglobin syndrome (thalassemia and drepanocytic anemia, etc.) 5.The chronic renal failure or a patient who has the renal dysfunction of CCr 50mL/min or less. 6.Patient who exists in serious state of mental disease of serious depression, thought of suicide or suicide plan, etc. or patient who has the previous history. 7.Patient with serious liver function trouble 8.Patient with autoimmune hepatitis 9.Patient who is administering the sho-sai-ko-to 10.Other chronic liver disease patients such as autoimmune hepatitis or alcoholic hepatitis. 11.Patient who has previous history of hypersensitivity for element of PEG-IFN alpha 2a or other interferon therapy. 12.Patient who has previous history of hypersensitivity for biological products such as vaccines. 13.Patient with cirrhosis, liver failure, and liver carcinoma. 14.Patient who is taking vitamin D3, bisphosphonate, SERM, and vitamin K preparation (Make it to the wash out period on one month or more, of six months or more, of one month or more, of one month or more respectively). 15.Additionally, patient judged by doctor that participation in this study is improper.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Virological response: the rate of patients negative for serum HCV-RNA after 24 weeks of the end of therapy (SVR: sustained virological response) | — |
Countries
Japan
Contacts
Public ContactYoshihiko Yano
Kobe University Hospital Gastroenterology
Outcome results
None listed