Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
108 participants
INTERVENTIONAL
2005-10-31
2010-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Interferon (IFN)-Treated
Pegasys®
180μg for s.c./week for 48 weeks
2
Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is positive at week 1
Pegasys®
180μg for s.c./week for 48 weeks
3
Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1
Pegasys®
180μg for s.c./week for 48 weeks
4
Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1
Pegasys®
180μg for s.c./week for 24 weeks
Interventions
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Pegasys®
180μg for s.c./week for 48 weeks
Pegasys®
180μg for s.c./week for 24 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Responsible Party
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Chugai Pharmaceutical
Principal Investigators
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Ken Kashima
Role: STUDY_DIRECTOR
Chugai Pharmaceutical
Locations
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Kyusyu Region
Fukuoka, , Japan
Chugoku Region
Okayama, , Japan
Kinki Region
Osaka, , Japan
Hokkaido Region
Sapporo, , Japan
Kanto Region
Tokyo, , Japan
Tokai Region
Yamanashi, , Japan
Countries
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Other Identifiers
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ML18501
Identifier Type: -
Identifier Source: org_study_id