Pegylated Interferon Alfa-2a for Dialysis Patients With Acute Hepatitis C

Hepatitis C Clinical Trial

Official title:

Pegylated Interferon Alfa-2a for Dialysis Patients With Acute Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917358
• Other study ID #: 940215
• Status: Completed
• Phase: Phase 4
• First received: June 8, 2009
• Last updated: December 19, 2012
• Start date: July 2005
• Est. completion date: June 2008

Study information

• Verified date: December 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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 studies for dialysis patients. The aim of the study is the evaluate the efficacy of peginterferon alfa-2a monotherapy for 24 weeks in this special clinical setting, and concomitantly evaluate retrospectively the dialysis patients with acute hepatitis C who did not receive intervention as the reference.

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 attributed to potential nosocomial exposure to hepatitis C virus during dialysis, resulting in high rates of acute hepatitis C virus infection. It is estimated that about 65-80% of the patients who have acute hepatitis C will evolve to chronic infection, leading to chronic hepatitis, cirrhosis, hepatic decompensation, and hepatocellular carcinoma (HCC). Currently, interferon and pegylated interferon monotherapy remains effective to treat acute hepatitis C in ordinary patients, with the sustained virologic response (SVR) rates ranging from 65-90% after 12-24 weeks of therapy. However, few data regarding the efficacy and safety of interferon-based monotherapy is known till now. Treatment of weekly 135 pegylated interferon alfa-2a has shown superior safety to thrice weekly 3 million unit (MU) standard interferon alfa-2a for dialysis patients with chronic hepatitis C. Under the excellent safety profiles of treating dialysis patients with low dose pegylated interferon alfa-2a, we aimed to evaluate the efficacy of weekly 135 ug pegylated interferon alfa-2a for a total of 24 weeks for dialysis patients with acute hepatitis C, and also evaluate the SVR rate by retrospective chart review for dialysis patients with acute hepatitis C who did not receive interferon-based therapy to evaluate if early intervention for these patients will improve overall disease outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Pegylated interferon alfa-2a
Pegylated interferon alfa-2a 135 ug/week for 24 weeks

Locations

Country	Name	City	State
Taiwan	Buddhist Tzu Chi General Hospital	Chiayi
Taiwan	Chiayi Christian Hospital	Chiayi
Taiwan	National Taiwan University Hospital, Yun-Lin Branch	Douliou
Taiwan	Far Eastern Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virologic response (SVR)		1.0 year	No