Sustained Virological Response (SVR)Rate of Pegasys Plus Ribavirin in Patients With Chronic Hepatitis C

July 27, 2015 updated by: I-Shyan Sheen, Chang Gung Memorial Hospital

A Randomized, Open-lable, Multicenter, Parallel Group Study to Compare SVR Rate of Pegasys Plus Ribavirin for 48 Weeks vs. 36 Weeks in Patients With Chronic Hepatitis C

The purpose of this study is to evaluate the effect of PEGASYS® (peginterferon alfa-2a 40KD) plus Robatrol® (ribavirin) combination therapy given for 36 weeks versus 48 weeks on the clearance of HCV viremia 24 weeks after treatment end

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Pegylated interferon plus ribavirin brings a good therapeutic response and curability. However, the adverse effects and sufferings are lots. Response-guided, personalized treatment is current principle. In patients of CHC, GT1 PR treatment for 24 weeks is established in rapid virologic responders (RVR) who have low viral load before treatment. As to patients with RVR but high viral load (HVL), the treatment duration is 48 weeks that is the same as patients with complete early virologic response (cEVR). Is a shorter duration of treatment feasible for those with a good virokinetic response? The ideal treatment duration for patients of chronic hepatitis C, GT-1, high viral load with RVR has had no enough data yet. Is it really necessary to double the treatment duration (48 weeks) for patients of chronic hepatitis C, GT-1, high viral load with RVR? Is 36-week adequate for them? A multicenter trial of INDIV-2 was presented at EASL 2010. They treated CHC patients of naïve GT1 HVL and RVR for 30 weeks and got similarly good SVR as those treated for 48 weeks (85% vs. 82%).

Therefore, investigators design a randomized controlled study to investigate the SVR rates between treatment for 36 weeks and for 48 weeks in patients of CHC, GT1, HVL and RVR.

Study Type

Interventional

Enrollment (Anticipated)

410

Phase

  • Not Applicable

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
      • Changhua City, Taiwan, 500
        • Show Chwan Memorial Hospital
      • Changhua County, Taiwan, 500
        • Changhua Christian Hospital
      • Keelung City, Taiwan, 222
        • Keelung Chang Gung Memorial Hospital
      • Taichung City, Taiwan, 404
        • China Medical University Hospital
      • Taichung City, Taiwan, 435
        • Tungs' Taichung MetroHarbor Hospital
      • Taipei County, Taiwan, 235
        • Taipei Medical University - Shuang Ho Hospital
      • Taoyuan County, Taiwan, 333
        • Linkou Medical Center, Chang Gung Memorial 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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 20~70 years old
  • Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribarivin
  • Chronic hepatitis C, genotype 1, HCV-RNA > 0.8x106 IU/ml, achieving RVR (undetectable HCV RNA at week 4) in the SoC treatment
  • Patient must be able to comply with the assessments during the study
  • Compensated liver disease (Child-Pugh Grade A clinical classification for patients with cirrhosis: total score ≦ 6)
  • All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment with study drugs and 6 months post treatment completion

Exclusion Criteria:

  • 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)
  • History or other evidence of decompensated liver disease
  • Signs or symptoms of hepatocellular carcinoma
  • Co-infection with hepatitis A, hepatitis B or human immunodeficiency virus (HIV)
  • Not adequately controlled thyroid dysfunction, diabetes mellitus (HbA1c >8.5%) or psychiatric disorders, 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
  • Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically relevant ophthalmological disorder (e.g. due to diabetes mellitus or hypertension)
  • Women with on-going pregnancy or breast feeding
  • Male partners of women who are pregnant

  • Subjects with any of the following laboratory abnormalities

    • Platelet count < 90,000/mm3
    • Absolute neutrophil count < 1,500 /mm3
    • Hemoglobin < 12 g/dL (F), 13 g/dL (M)
    • Creatinine > ULN
    • ALT and/or AST > 10X ULN
    • Total serum bilirubin > 1.5 x ULN
  • Inability or unwillingness to provide written informed consent or abide by the requirements of the study

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEGASYS® plus ROBATROL® for 36 weeks
Drug: Peginterferon alfa-2a plus Ribavirin
Peginterferon alfa-2a(pre-filled syringes 180 mcg/0.5 ml once a week) plus ribavirin(200 mg/Capsules, 1000~1200 mg daily in split doses (morning/evening)) for 36 or 48 weeks
Other Names:
  • PEGASYS® plus ROBATROL®
Active Comparator: PEGASYS® plus ROBATROL® for 48 weeks
Drug: Peginterferon alfa-2a plus Ribavirin
Peginterferon alfa-2a(pre-filled syringes 180 mcg/0.5 ml once a week) plus ribavirin(200 mg/Capsules, 1000~1200 mg daily in split doses (morning/evening)) for 36 or 48 weeks
Other Names:
  • PEGASYS® plus ROBATROL®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained virological response
Time Frame: At 24 weeks after end of treatment
Sustained virological response (SVR) defined as percentage of patients with HCV RNA < 15 IU/ML as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test at 24 weeks post completion of the 36 or 48 week treatment periods.
At 24 weeks after end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Virological Response Rate at week 2
Time Frame: At treatment week 2
Virological Response Rate at week 2 defined as the percentage of patients with HCV RNA < 15 IU/ML as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV at 2 weeks post treatment.
At treatment week 2
Virological response at end of treatment
Time Frame: At end of treatment
Virological response at end of treatment defined as the percentage of patients with HCV RNA < 15 IU/ML as measured by the Roche COBAS AmpliPrep / COBAS TaqMan® HCV Test after the last dose of study medication(± 28 days).
At end of treatment
Correlation of virological response and SVR rate
Time Frame: At 24 weeks after end of treatment
Correlation of virological response (HCV RNA < 15 IU/ML) at week 2 and SVR rate in each group.
At 24 weeks after end of treatment

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: I-Shyan Sheen, M.D., Linkou Medical Center, Chang Gung Memorial Hospital

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

July 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

June 28, 2012

First Submitted That Met QC Criteria

July 10, 2012

First Posted (Estimate)

July 12, 2012

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTC-133

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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