Clinical trial NCT00917358: Pegylated Interferon Alfa-2a for Dialysis Patients With Acute Hepatitis C
Official title: Pegylated Interferon Alfa-2a for Dialysis Patients With Acute Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
Keywords: Hepatitis C
Dialysis
Interferon
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2009-06-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sustained virologic response (SVR)
timeFrame: 1.0 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chiayi
country: Taiwan
facility: Buddhist Tzu Chi General Hospital
city: Chiayi
country: Taiwan
facility: Chiayi Christian Hospital
city: Douliou
country: Taiwan
facility: National Taiwan University Hospital, Yun-Lin Branch
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chen-Hua Liu, MD
role: STUDY_CHAIR
affiliation: National Taiwan University Hospital
name: Jia-Horng Kao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Far Eastern Memorial Hospital
name: Cheng-Chao Liang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital, Yun-Lin Branch
name: Shih-Jer Hsu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Buddhist Tzu Chi General Hospital
name: Hung-Bin Tsai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chiayi Christian Hospital
name: Peir-Haur Hung, MD
role: PRINCIPAL_INVESTIGATOR
References: