UMIN ID: C000000175
Registered date:12/09/2005
Pegylated IFN alpha-2b/Ribavirin therapy for chronic hepatitis C with genotype Ib, high titer-analysis with viral clearance.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Chronic hepatitis C |
| Date of first enrollment | 2005/01/01 |
| Target sample size | 250 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Negative for HCVRNA at 4 weeks of therapy. PEG-IFN alpha-2b/ribavirin (48weeks) Positive for HCVRNA at 4 weeks of therapy. PEG-IFN alpha-2b/ribavirin (48 weeks) Positive for HCVRNA at 4 weeks of therapy. PEG-IFN alpha-2b/ribavirin (48 weeks) plus IFN alpha-2b (24weeks) |
Outcome(s)
| Primary Outcome | Sustained virological response rate |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 70years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1)Complicated with other liver diseases such as autoimmune hepatitis and alcoholic liver injury. (2)Liver cirrhosis, hepatic failure. (3)Drug allergy for IFN or ribavirin. (4)Drug allergy for vaccine. (5)Administration of other anti-viral or immunomodulatory treatment. (6)Pregnancy. (7)Depression. (8)Complicated with autoimmune disorders. |
Related Information
| Primary Sponsor | Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Satoru Kakizaki |
| Address | 3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan Japan |
| Telephone | 027-220-8127 |
| kakizaki@showa.gunma-u.ac.jp | |
| Affiliation | Gunma University Graduate School of Medicine Department of Medicine and Molecular Science |
| scientific contact | |
| Name | Hitoshi Takagi |
| Address | 3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan Japan |
| Telephone | 027-220-8127 |
| htakagi@med.gunma-u.ac.jp | |
| Affiliation | Gunma University Graduate School of Medicine Department of Medicine and Molecular Science |