Four Arms, Multicenter Study of Tailored Regimens With Peginterferon Plus Ribavirin for Genotype 2 Chronic Hepatitis C

December 24, 2014 updated by: MING-LUNG,YU, Kaohsiung Medical University Chung-Ho Memorial Hospital

Four Arms, Multicenter, Open Label Study of Tailored Regimens With Peginterferon Plus Ribavirin for Genotype 2 Chronic Hepatitis C

The purposes of this study are:

  1. To evaluate the efficacy and safety of low-dose versus standard-dose of ribavirin in combination with peginterferon alfa-2a given for 16 weeks in hepatitis C virus (HCV) genotype 2 infected, treatment-naïve chronic hepatitis C patients after achieving a rapid virologic response (RVR,defined as seronegativity of HCV RNA at week 4 of treatment).
  2. To evaluate the efficacy and safety of 24-week versus 48-week regimen of peginterferon alfa-2a plus standard-dose of ribavirin in HCV genotype 2 infected, treatment-naïve chronic hepatitis C patients who have no RVR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The recommended regimen for treating HCV genotype 2 patients is peginterferon plus low dose ribavirin (800 mg/day) for 24 weeks. Recently studies have demonstrated that a shorter treatment duration of 12-16 weeks of peginterferon plus standard weight-based dose of ribavirin (800-1400 mg/day) is as effective as a 24-week regimen among HCV genotype 2 patients with a RVR at week 4 of treatment (rate of sustained virological response, SVR, approximately 90%). However, for patients without a RVR at week 4 the efficacy of 24 week treatment remains unsatisfied. Individualized therapy with tailored regimen according to baseline and on-treatment virological factors, without compromising efficacy, is the future strategy in the management of chronic hepatitis C.

The aims of the present study are

  1. To evaluate the efficacy and safety of low-dose versus standard-dose of ribavirin in combination with peginterferon alfa-2a given for 16 weeks in hepatitis C virus (HCV) genotype 2 infected, treatment-naïve chronic hepatitis C patients after achieving a rapid virologic response (RVR,defined as seronegativity of HCV RNA at week 4 of treatment).
  2. To evaluate the efficacy and safety of 24-week versus 48-week regimen of peginterferon alfa-2a plus standard-dose of ribavirin in HCV genotype 2 infected, treatment-naïve chronic hepatitis C patients who have no RVR.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients 18 years of age
  • Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
  • Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
  • Detectable serum HCV-RNA and HCV viral genotype 2
  • Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)
  • Compensated liver disease (Child-Pugh Grade A clinical classification)
  • Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
  • All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end

Exclusion Criteria:

  • Women with ongoing pregnancy or breast feeding
  • Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug
  • Any investigational drug 6 weeks prior to the first dose of study drug
  • Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV)
  • History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
  • Signs or symptoms of hepatocellular carcinoma
  • History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
  • Neutrophil count < 1500 cells/mm3 or platelet count < 90,000 cells/mm3 at screening
  • Serum creatinine level > 1.5 times the upper limit of normal at screening
  • History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
  • History of a severe seizure disorder or current anticonvulsant use
  • History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
  • Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
  • Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
  • Inability or unwillingness to provide informed consent or abide by the requirements of the study
  • Male partners of women who are pregnant
  • Hgb < 11 g/dL in women or < 12 g/dL in men at screening
  • Any patient with major thalassemia
  • Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well-tolerated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A, RVR LD RBV
Patients who have a RVR will be randomized into two groups with a ratio of 1:1 (Arm A & B)B, RVR SD RBV A, RVR LD RBV B, RVR SD RBV
Drug: pegylated interferon alpha 2a and plus ribavirin
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 4 weeks followed by pegylated interferon alpha 2a 180 mcg/week and Ribavirin 800 mg/day for 12 weeks, follow up for 24 weeks
Other Names:
  • PEGASYS®
Active Comparator: B, RVR SD RBV
Patients who have a RVR will be randomized into two groups with a ratio of 1:1 (Arm A & B)B, RVR SD RBV
Drug: Pegylated interferon alfa-2a and ribavirin
pegylated interferon alfa-2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 16 weeks, follow up for 24 weeks
Other Names:
  • PEGASYS®
Active Comparator: C, non-RVR 24w
For patients who do not have a RVR will be randomized into two groups with a ratio of 1:1 (Arm C & D) (C, non-RVR 24w) (D, non-RVR 48w)
Drug: pegylated interferon alpha 2a and ribavirin
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
Other Names:
  • PEGASYS®
Drug: pegylated interferon alpha 2a and ribavirin
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 48 weeks, follow up for 24 weeks
Other Names:
  • PEGASYS®
Active Comparator: D, non-RVR 48w
For patients who do not have a RVR will be randomized into two groups with a ratio of 1:1 (Arm C & D)(C, non-RVR 24w) (D, non-RVR 48w)
Drug: pegylated interferon alpha 2a and ribavirin
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
Other Names:
  • PEGASYS®
Drug: pegylated interferon alpha 2a and ribavirin
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 48 weeks, follow up for 24 weeks
Other Names:
  • PEGASYS®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy - Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4 Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period
Time Frame: 1.5 year
1.5 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety - adverse event rate and profile
Time Frame: 1.5 year
1.5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 5, 2007

First Submitted That Met QC Criteria

October 5, 2007

First Posted (Estimate)

October 8, 2007

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 24, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUH-IRB-960057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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