Trial of Pegasys® in Patients With Chronic Hepatitis C

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Pegasys®

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

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

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

Sites / Locations

Kyusyu Region
Chugoku Region
Kinki Region
Hokkaido Region
Kanto Region
Tokai Region

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

1

2

3

4

Arm Description

Interferon (IFN)-Treated

Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is positive at week 1

Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1

Outcomes

Primary Outcome Measures

Sustained viral response as undetectable level of HCV-RNA

Secondary Outcome Measures

Biochemical response as normal level of ALT

Viral response as undetectable level of HCV-RNA

Full Information

NCT ID

NCT00245414

First Posted

October 27, 2005

Last Updated

November 16, 2010

Sponsor

Chugai Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT00245414

Brief Title

Trial of Pegasys® in Patients With Chronic Hepatitis C

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Chugai Pharmaceutical

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Arm Description

Interferon (IFN)-Treated

Arm Title

2

Arm Type

Experimental

Arm Description

Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is positive at week 1

Arm Title

3

Arm Type

Experimental

Arm Description

Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1

Arm Title

4

Arm Type

Experimental

Arm Description

Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1

Intervention Type

Drug

Intervention Name(s)

Pegasys®

Intervention Description

180μg for s.c./week for 48 weeks

Intervention Type

Drug

Intervention Name(s)

Pegasys®

Intervention Description

180μg for s.c./week for 24 weeks

Primary Outcome Measure Information:

Title

Sustained viral response as undetectable level of HCV-RNA

Time Frame

week 24 from the end of treatment

Secondary Outcome Measure Information:

Title

Biochemical response as normal level of ALT

Time Frame

week 24 from the end of treatment

Title

Viral response as undetectable level of HCV-RNA

Time Frame

at the end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ken Kashima

Organizational Affiliation

Chugai Pharmaceutical

Official's Role

Study Director

Facility Information:

Facility Name

Kyusyu Region

City

Fukuoka

Country

Japan

Facility Name

Chugoku Region

City

Okayama

Country

Japan

Facility Name

Kinki Region

City

Osaka

Country

Japan

Facility Name

Hokkaido Region

City

Sapporo

Country

Japan

Facility Name

Kanto Region

City

Tokyo

Country

Japan

Facility Name

Tokai Region

City

Yamanashi

Country

Japan

Chronic Hepatitis C

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial