Trial of Pegasys® in Patients With Chronic Hepatitis C

Sponsor

Chugai Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT00245414

Collaborator

(none)

108

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C	Drug: Pegasys® Drug: Pegasys®	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2005

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Sustained viral response as undetectable level of HCV-RNA [week 24 from the end of treatment]

Secondary Outcome Measures

Biochemical response as normal level of ALT [week 24 from the end of treatment]
Viral response as undetectable level of HCV-RNA [at the end of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Kyusyu Region	Fukuoka	Japan
2	Chugoku Region	Okayama	Japan
3	Kinki Region	Osaka	Japan
4	Hokkaido Region	Sapporo	Japan
5	Kanto Region	Tokyo	Japan
6	Tokai Region	Yamanashi	Japan