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

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Pegylated interferon alfa-2a
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, Dialysis, Interferon

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Buddhist Tzu Chi General Hospital
  • Chiayi Christian Hospital
  • National Taiwan University Hospital, Yun-Lin Branch
  • National Taiwan University Hospital
  • Far Eastern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pegylated interferon alfa-2a

Observation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Sustained virologic response (SVR)

Secondary Outcome Measures

Full Information

First Posted
June 8, 2009
Last Updated
December 19, 2012
Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT00917358
Brief Title
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

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis C, Dialysis, Interferon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pegylated interferon alfa-2a
Arm Type
Experimental
Arm Description
Pegylated interferon alfa-2a 135 ug/week for 24 weeks
Arm Title
Observation
Arm Type
No Intervention
Arm Description
Retrospectively chart review of dialysis patients with acute hepatitis C who did not receive any intervention
Intervention Type
Drug
Intervention Name(s)
Pegylated interferon alfa-2a
Other Intervention Name(s)
Pegylated interferon alfa-2a (Pegasys, Hoffman-La Roche)
Intervention Description
Pegylated interferon alfa-2a 135 ug/week for 24 weeks
Primary Outcome Measure Information:
Title
Sustained virologic response (SVR)
Time Frame
1.0 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen-Hua Liu, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jia-Horng Kao, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cheng-Chao Liang, MD
Organizational Affiliation
Far Eastern Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shih-Jer Hsu, MD
Organizational Affiliation
National Taiwan University Hospital, Yun-Lin Branch
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hung-Bin Tsai, MD
Organizational Affiliation
Buddhist Tzu Chi General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peir-Haur Hung, MD
Organizational Affiliation
Chiayi Christian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buddhist Tzu Chi General Hospital
City
Chiayi
Country
Taiwan
Facility Name
Chiayi Christian Hospital
City
Chiayi
Country
Taiwan
Facility Name
National Taiwan University Hospital, Yun-Lin Branch
City
Douliou
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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

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