UMIN ID: UMIN000000897
Registered date:17/11/2007
A comparison of peginterferon ribavirin combination therapies for chronic hepatitis C
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | chronic hepatitis C with high viral load (>100KIU/ml) and serogroup I |
| Date of first enrollment | 2007/11/01 |
| Target sample size | 320 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | peginterferon alfa-2b in combination with ribavirin peginterferon alfa-2a in combination with ribavirin |
Outcome(s)
| Primary Outcome | SVR(sustained virologic response:no detectable hepatitis C virus in their blood 6 months after treatment has ended) rate |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | The exclusion criteria are as follows: 1.liver disease such as autoimmune hepatitis, coinfection with hepatitis B, 2.severe renal disease, Ccr <50ml/min 3.poorly controlled heart disease 4.depression or psychosomatic disorders 5.Sho-saiko-to treatment within 30 days before interferon administration 6.pregnant or lactating women and women who may be pregnant 7.a man who can not avoid conception during administration of ribavirin and until 6 month after the end ribavirin treatment 8.drug allergy against interferon or ribavirin 9.allergy against biological drugs 10.no prior therapy of peginterferon in combination with ribavirin 11.on other clinical trial 12.any reason which medical doctor regard the patient as unsuitable for this test |
Related Information
| Primary Sponsor | University of Tokyo Department of Gastroenterology, Faculty of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Tadashi Goto |
| Address | 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan Japan |
| Telephone | 03-3815-5411 |
| tadagotou-gi@umin.ac.jp | |
| Affiliation | University of Tokyo Department of Gastroenterology, Faculty of Medicine |
| scientific contact | |
| Name | Haruhiko Yoshida |
| Address | 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan Japan |
| Telephone | 03-3815-5411 |
| yoshida-2im@h.u-tokyo.ac.jp | |
| Affiliation | University of Tokyo Department of Gastroenterology, Faculty of Medicine |