Trial of Pegasys® in Patients With Chronic Hepatitis C

November 16, 2010 updated by: Chugai Pharmaceutical

Post-marketing Clinical Trial of Pegasys® 180μg for Subcutaneous Injection in Patients With Chronic Hepatitis C. General Clinical Study in Interferon (IFN)-Treated and IFN-untreated Chronic Hepatitis C Patients, Except for Those Infected With High Viral Load of Genotype 1b

The purpose of this study is to investigate the efficacy and safety of Pegasys® 180μg for subcutaneous (s.c.) injection in interferon (IFN)-treated or IFN-untreated chronic hepatitis C patients except for those infected with genotype 1b of hepatitis C virus (HCV) and a high viral load (≥ 100 KIU/mL).

In addition, this study will explore the efficacy and safety of Pegasys® 180μg for s.c. injection given at 2 different periods between 24 and 48 weeks in IFN-untreated chronic hepatitis C patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

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

  • Japan
      • Fukuoka, Japan
        • Kyusyu region
      • Okayama, Japan
        • Chugoku region
      • Osaka, Japan
        • Kinki region
      • Sapporo, Japan
        • Hokkaido region
      • Tokyo, Japan
        • Kanto region
      • Yamanashi, Japan
        • Tokai region

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Quantitative serum HCV-RNA is positive except for high viral load of genotype 1b (≥ 100 KIU/mL)
  • Observation of serum ALT elevation above upper limit of normal
  • Chronic hepatitis is evaluated as the negative result (< 0) calculated by the method of "formula for discrimination between chronic hepatitis and liver cirrhosis."

Exclusion Criteria:

  • Observation of white blood cells ≦ 3000/mm3; neutrophils ≦ 1500/mm3; platelets ≦ 90,000/mm3; or hemoglobin ≦ 10 g/dL.
  • Observation of the following situations and disease: severe renal disease, hepatitis B co-infection, de-compensated liver disease, liver cirrhosis, hepatocellular carcinoma, poorly controlled psychiatric disease, seizure disorders, immunologically mediated disease, severe cardiac disease, poorly uncontrolled hypertension, poorly controlled diabetes, chronic pulmonary disease, retinopathy, malignant tumor, and organ transplant

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Interferon (IFN)-Treated
Drug: Pegasys®
180μg for s.c./week for 48 weeks
Drug: Pegasys®
180μg for s.c./week for 24 weeks
Experimental: 2
Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is positive at week 1
Drug: Pegasys®
180μg for s.c./week for 48 weeks
Drug: Pegasys®
180μg for s.c./week for 24 weeks
Experimental: 3
Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1
Drug: Pegasys®
180μg for s.c./week for 48 weeks
Drug: Pegasys®
180μg for s.c./week for 24 weeks
Experimental: 4
Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1
Drug: Pegasys®
180μg for s.c./week for 48 weeks
Drug: Pegasys®
180μg for s.c./week for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sustained viral response as undetectable level of HCV-RNA
Time Frame: week 24 from the end of treatment
week 24 from the end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Biochemical response as normal level of ALT
Time Frame: week 24 from the end of treatment
week 24 from the end of treatment
Viral response as undetectable level of HCV-RNA
Time Frame: at the end of treatment
at the end of treatment

Collaborators and Investigators

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

Sponsor

Chugai Pharmaceutical

Investigators

  • Study Director: Ken Kashima, Chugai Pharmaceutical

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, 2005

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

October 27, 2005

First Submitted That Met QC Criteria

October 27, 2005

First Posted (Estimate)

October 28, 2005

Study Record Updates

Last Update Posted (Estimate)

November 17, 2010

Last Update Submitted That Met QC Criteria

November 16, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML18501

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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