Trial of Pegasys® in Patients With Chronic Hepatitis C

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00245414

Enrollment

108

Registered

2005-10-28

Start date

2005-10-31

Completion date

2010-07-31

Last updated

2010-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

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.

Interventions

DRUGPegasys®

180μg for s.c./week for 48 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026