Trial of Pegasys® in Patients With Chronic Hepatitis C

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245414
• Other study ID #: ML18501
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2005
• Last updated: November 16, 2010
• Start date: October 2005
• Est. completion date: July 2010

Study information

• Verified date: November 2010
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Pegasys®
180µg for s.c./week for 48 weeks
• Pegasys®
180µg for s.c./week for 24 weeks

Locations

Country	Name	City	State
Japan	Kyusyu Region	Fukuoka
Japan	Chugoku Region	Okayama
Japan	Kinki Region	Osaka
Japan	Hokkaido Region	Sapporo
Japan	Kanto Region	Tokyo
Japan	Tokai Region	Yamanashi

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained viral response as undetectable level of HCV-RNA		week 24 from the end of treatment	No
Secondary	Biochemical response as normal level of ALT		week 24 from the end of treatment	No
Secondary	Viral response as undetectable level of HCV-RNA		at the end of treatment	No