Hepatitis C, Chronic Clinical Trial
| Verified date | September 2015 |
| Source | Kyoto University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Observational |
The purpose of this study is to evaluate the efficacy and safety of low-dose interferon-alfa-2b plus ribavirin compared to the standard-dose of the same combination in patients with chronic hepatitis C.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | May 2008 |
| Est. primary completion date | May 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Clinical diagnosis of Chronic Hepatitis C. Must be infected with genotype 1b viruses Exclusion Criteria: - Hemoglobin levels<8.5g/dL, - Platelet counts<50,000/mm3, - Total polymorphonuclear counts<1000/mm3 - Pregnancy, - Renal dysfunction, |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Japan | Department of Gastroenterology and Hepatology, Kyoto University Hospital | Kyoto | |
| Japan | Kitano Hospital | Osaka | |
| Japan | Osaka Red Cross Hospital | Osaka | |
| Japan | Wakayama Red Cross Hospital | Wakayama |
| Lead Sponsor | Collaborator |
|---|---|
| Kyoto University |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | rate of sustained viral response | 6 months | Yes |
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