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A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)

Primary Purpose

Liver Cirrhosis, Chronic Hepatitis C

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
peginterferon alfa-2a 180μg
peginterferon alfa-2a 90μg
ribavirin
Sponsored by
Chugai Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring CHC with compensated LC

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged 20 to 75 years-old with quantifiable serum HCV-RNA (≥ 500 IU/mL), elevated serum alanine aminotransferase activity (≥ 45 IU per liter) within sixty days of screening, and proven CHC with compensated LC (Child-Pugh A) on liver biopsy. Exclusion Criteria: Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter) Thrombocytopenia (fewer than 75,000 platelets per cubic millimeter) Anemia (less than 12 g hemoglobin per deciliter ) Hepatitis B co-infection; decompensated liver disease. Organ transplant Creatinine clearance less than 50 milliliters per minute Poorly controlled psychiatric disease Poorly controlled diabetes Malignant neoplastic disease Severe cardiac or chronic pulmonary disease Immunologically mediated disease Retinopathy

Sites / Locations

  • Chugoku
  • Hokkaido Region
  • Kanto Region
  • Kinki Region
  • Kyusyu Region
  • Shikoku Region
  • Tohoku Region
  • Tokai Region

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Sustained virological response, defined as undetectable hepatitis C virus (HCV)-RNA (< 50 IU per milliliter [IU/mL])

Secondary Outcome Measures

Biochemical response (normalization of serum alanine aminotransferase activity)
Virological response (HCV-RNA < 50 IU per milliliter)

Full Information

First Posted
March 5, 2006
Last Updated
June 1, 2010
Sponsor
Chugai Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00304551
Brief Title
A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)
Official Title
A Phase II/III Study of Peginterferon Alfa-2a in Combination With Ribavirin for the Treatment of CHC With Compensated LC
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chugai Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC. Additionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC patients with compensated LC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Chronic Hepatitis C
Keywords
CHC with compensated LC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a 180μg
Intervention Description
180μg（s.c.）/week for 48 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a 90μg
Intervention Description
90μg(s.c.)/week for 48 weeks
Intervention Type
Drug
Intervention Name(s)
ribavirin
Intervention Description
600, 800, or 1,000 mg X 2(p.o.)/day
Primary Outcome Measure Information:
Title
Sustained virological response, defined as undetectable hepatitis C virus (HCV)-RNA (< 50 IU per milliliter [IU/mL])
Time Frame
week 24 from the end of treatment
Secondary Outcome Measure Information:
Title
Biochemical response (normalization of serum alanine aminotransferase activity)
Time Frame
at the end of treatment and week 24 form the end of treatment
Title
Virological response (HCV-RNA < 50 IU per milliliter)
Time Frame
at the end of treatment and week 24 form the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 20 to 75 years-old with quantifiable serum HCV-RNA (≥ 500 IU/mL), elevated serum alanine aminotransferase activity (≥ 45 IU per liter) within sixty days of screening, and proven CHC with compensated LC (Child-Pugh A) on liver biopsy. Exclusion Criteria: Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter) Thrombocytopenia (fewer than 75,000 platelets per cubic millimeter) Anemia (less than 12 g hemoglobin per deciliter ) Hepatitis B co-infection; decompensated liver disease. Organ transplant Creatinine clearance less than 50 milliliters per minute Poorly controlled psychiatric disease Poorly controlled diabetes Malignant neoplastic disease Severe cardiac or chronic pulmonary disease Immunologically mediated disease Retinopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takehiko Aoshima
Organizational Affiliation
Clinical Research Department 4, Chugai Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Chugoku
City
Chugoku
Country
Japan
Facility Name
Hokkaido Region
City
Hokkaido
Country
Japan
Facility Name
Kanto Region
City
Kanto
Country
Japan
Facility Name
Kinki Region
City
Kinki
Country
Japan
Facility Name
Kyusyu Region
City
Kyusyu
Country
Japan
Facility Name
Shikoku Region
City
Shikoku
Country
Japan
Facility Name
Tohoku Region
City
Tohoku
Country
Japan
Facility Name
Tokai Region
City
Tokai
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)

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