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100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01378104
Recruitment Status : Completed
First Posted : June 22, 2011
Results First Posted : March 8, 2013
Last Update Posted : March 8, 2013
Sponsor:
Collaborators:
Ulsan University Hospital
National Health Insurance Service Ilsan Hospital
Inje University
Soonchunhyang University Hospital
Yonsei University
Chungnam National University
Keimyung University
Kyungpook National University Hospital
Konyang University Hospital
Inha University Hospital
Hallym University Medical Center
Information provided by (Responsible Party):
Jung Hyun Kwon, The Catholic University of Korea

Study Description
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Brief Summary:
  1. Randomized controlled multicenter study
  2. The response of reducing dose of peginterferon alfa-2a in Koreans with chronic hepatitis C genotype 1
  3. IL28B polymorphism in Koreans with CHC

Condition or disease Intervention/treatment Phase
Sustained Virologic Response IL28B Polymorphism Drug: peginterferon alfa 2a (pegasys) Drug: peginterferon alfa-2a (pegasys) Phase 4

Detailed Description:

The virologic response of Koreans to combination therapy for chronic hepatitis C is similar to non-Asians; however, dose modification occurs more frequently in Koreans.

-When we evaluated the rates of peginterferon α-2a and ribavirin dose modifications and their effect on the virologic response in Koreans, we suggested that using at least 80% of the peginterferon α-2a dose in Koreans not only maintains SVR but also reduces drug side effects during the entire treatment period and a lower dose of ribavirin may be as efficacious as a standard dose(Korean J Intern Med 2009;24:203-211).

So we investigate whether the group of 80% use dosage of peginterferon alfa-2a did not show inferior response rather than that of 100 % use dosage group and minimize the adverse events.

There are recently reports that Koreans have favorable IL28B SNP for CHC treatment.

-We investigate the IL28B polymorphism in Koreans with CHC and this result can effect on the SVR depending on the dosage of peginterferon alfa 2a

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Response of Reducing Dose of Peginterferon Alfa-2a in Koreans With Chronic Hepatitis C Genotype 1; Randomized Controlled Multicenter Study 100% Versus 80%
Study Start Date : October 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 80% dosage group of peginterferon alfa 2a
This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.
 Drug: peginterferon alfa 2a (pegasys)
dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable
Other Name: Roche
Active Comparator: 100% dosage group of peginterferon alfa 2a
These group patients would be treated with standard dose 180 ug/week for 48 weeks.
 Drug: peginterferon alfa-2a (pegasys)
These patients would be treated with standard dose 180ug /week for 48 weeks. In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.
Other Name: Roche


Outcome Measures
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Primary Outcome Measures :
  1. Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a [ Time Frame: post treatment 24 weeks ]
    We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different.


Secondary Outcome Measures :
  1. IL28B Polymorphism Effect on SVR [ Time Frame: post treatment 24 weeks ]
    We additionally investigate the IL28B polymorphism and this result can effect on the SVR depending on dosage of peginterferon alfa-2a.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • chronic hepatitis C (anti HCV+, HCV RNA +)
  • Genotype 1
  • over 18 year-old
  • Pregnancy test negative if women of childbearing age

Exclusion Criteria:

  • pregnant women or breast feeding women
  • systemic chemotherapy or steroid therapy before 6 months of trial
  • Coinfection with HAV, HBV, and HIV
  • Other liver disease such as hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxic hepatitis
  • Hepatocellular carcinoma
  • Evidence of decompensation such as variceal bleeding,ascites, encephalopathy
  • ANC less than 1500, platelet less than 90k
  • Cr more than 1.5 of UNL
  • Severe psychiatric problem
  • Poorly controlled thyroid disease
  • Severe retinopathy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01378104


Locations
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Korea, Republic of
Soonchunghyang University Hospital
Bucheon, Korea, Republic of
Hallym University Chunchun Medical center
Chunchun, Korea, Republic of
Keimyung University hospital
Daegu, Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of
Ghungnam National University hospital
Daejun, Korea, Republic of
Konyang University hospital
Daejun, Korea, Republic of
Incheon St. Mary's Hospital
Incheon, Korea, Republic of
Inha University hospital
Incheon, Korea, Republic of
Inje University, Ilsan Paik Hospital
Koyang-si, Korea, Republic of
NHIC Ilsan hospital
Koyang-si, Korea, Republic of
Inje University, Pusan Paik Hospital
Pusan, Korea, Republic of
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of
Ulsan university
Ulsan, Korea, Republic of
Yonsei University, Wonju Hospital
Wonju-si, Korea, Republic of
Sponsors and Collaborators
The Catholic University of Korea
Ulsan University Hospital
National Health Insurance Service Ilsan Hospital
Inje University
Soonchunhyang University Hospital
Yonsei University
Chungnam National University
Keimyung University
Kyungpook National University Hospital
Konyang University Hospital
Inha University Hospital
Hallym University Medical Center
Investigators
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Principal Investigator: Jung Hyun Kwon, MD, Assistant professor The Catholic University of Korea
More Information
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Responsible Party: Jung Hyun Kwon, Assistant professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01378104    
Other Study ID Numbers: PEGASYS100:80
First Posted: June 22, 2011    Key Record Dates
Results First Posted: March 8, 2013
Last Update Posted: March 8, 2013
Last Verified: February 2013
Keywords provided by Jung Hyun Kwon, The Catholic University of Korea:
reducing dose of peginterferon
chronic hepatitis c
Koreans
IL28B polymorphism
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
RNA Virus Infections
 Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs