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

NCT ID: NCT00917358

Last Updated: 2012-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Hepatitis C

Keywords

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Hepatitis C Dialysis Interferon

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pegylated interferon alfa-2a

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

Group Type EXPERIMENTAL

Pegylated interferon alfa-2a

Intervention Type DRUG

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

Observation

Retrospectively chart review of dialysis patients with acute hepatitis C who did not receive any intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pegylated interferon alfa-2a

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

Intervention Type DRUG

Other Intervention Names

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Pegylated interferon alfa-2a (Pegasys, Hoffman-La Roche)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chen-Hua Liu, MD

Role: STUDY_CHAIR

National Taiwan University Hospital

Jia-Horng Kao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Cheng-Chao Liang, MD

Role: PRINCIPAL_INVESTIGATOR

Far Eastern Memorial Hospital

Shih-Jer Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital, Yun-Lin Branch

Hung-Bin Tsai, MD

Role: PRINCIPAL_INVESTIGATOR

Buddhist Tzu Chi General Hospital

Peir-Haur Hung, MD

Role: PRINCIPAL_INVESTIGATOR

Chiayi Christian Hospital

Locations

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Buddhist Tzu Chi General Hospital

Chiayi City, , Taiwan

Site Status

Chiayi Christian Hospital

Chiayi City, , Taiwan

Site Status

National Taiwan University Hospital, Yun-Lin Branch

Douliu, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Far Eastern Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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940215

Identifier Type: -

Identifier Source: org_study_id