Examination of efficacy and safety of administration of vitamin D3 with the PEG-IFN alpha 2a/Ribavirin therapy to hepatitis C patients with osteoporosis.

Not Applicable

Recruiting

• Conditions: hepatitis C

• Registration Number: JPRN-UMIN000004628
• Lead Sponsor: Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Virological response: the rate of patients negative for serum HCV-RNA after 24 weeks of the end of therapy (SVR: sustained virological response)