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

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00917358
First received: June 8, 2009
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: Pegylated interferon alfa-2a
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pegylated Interferon Alfa-2a for Dialysis Patients With Acute Hepatitis C

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Sustained virologic response (SVR) [ Time Frame: 1.0 year ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: July 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pegylated interferon alfa-2a
Pegylated interferon alfa-2a 135 ug/week for 24 weeks
Drug: Pegylated interferon alfa-2a
Pegylated interferon alfa-2a 135 ug/week for 24 weeks
Other Name: Pegylated interferon alfa-2a (Pegasys, Hoffman-La Roche)
No Intervention: Observation
Retrospectively chart review of dialysis patients with acute hepatitis C who did not receive any intervention

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917358

Locations
Taiwan
Buddhist Tzu Chi General Hospital
Chiayi, Taiwan
Chiayi Christian Hospital
Chiayi, Taiwan
National Taiwan University Hospital, Yun-Lin Branch
Douliou, Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10002
Far Eastern Memorial Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Study Chair: Chen-Hua Liu, MD National Taiwan University Hospital
Principal Investigator: Jia-Horng Kao, MD, PhD National Taiwan University Hospital
Principal Investigator: Cheng-Chao Liang, MD Far Eastern Memorial Hospital
Principal Investigator: Shih-Jer Hsu, MD National Taiwan University Hospital, Yun-Lin Branch
Principal Investigator: Hung-Bin Tsai, MD Buddhist Tzu Chi General Hospital
Principal Investigator: Peir-Haur Hung, MD Chiayi Christian Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00917358     History of Changes
Other Study ID Numbers: 940215
Study First Received: June 8, 2009
Last Updated: December 19, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Hepatitis C
Dialysis
Interferon

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Interferon-alpha
Peginterferon alfa-2a
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014