Status:
COMPLETED
Pegylated Interferon Alfa-2a for Dialysis Patients With Acute Hepatitis C
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Science and Technology Council, Taiwan
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Interferon-based monotherapy has been considered effective to treat acute hepatitis C in ordinary patients. However, the efficacy of this treatment has not been evaluated in prospective interventional...
Detailed Description
Chronic viral hepatitis is common in dialysis patients, with the reported prevalence and annual incidence of 3-80% and 2.9%, respectively. The high incidence and prevalence in thse patients are attrib...
Eligibility Criteria
Inclusion
- Age 18-65 years old
- Creatinine clearance (Ccr) \< 10 ml/min/1.73 m2
- Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive \< 6 months with defined seroconversion
- Detectable serum quantitative HCV-RNA (Cobas Taqman HCV test, version 2, Roche Diagnostics) with a dynamic range of 25-391000000 IU/ml
Exclusion
- Severe anemia (hemoglobin \< 10 g/dL) or hemoglobinopathy
- Neutropenia (neutrophil count, \<1,500/mm3)
- Thrombocytopenia (platelet \<90,000/ mm3)
- Co-infection with HBV or HIV
- Chronic alcohol abuse (daily consumption \> 20 g/day)
- Autoimmune liver disease
- Decompensated liver disease (Child classification B or C)
- Neoplastic disease
- An organ transplant
- Immunosuppressive therapy
- Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
- Evidence of drug abuse
- Unwilling to have contraception
- Unwilling to sign inform consent
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00917358
Start Date
July 1 2005
End Date
June 1 2008
Last Update
December 20 2012
Active Locations (5)
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1
Buddhist Tzu Chi General Hospital
Chiayi City, Taiwan
2
Chiayi Christian Hospital
Chiayi City, Taiwan
3
National Taiwan University Hospital, Yun-Lin Branch
Douliu, Taiwan
4
National Taiwan University Hospital
Taipei, Taiwan, 10002