Effect of Low-dose PegIntron on ALT Normalization in Japanese Patients With Chronic Hepatitis C (Study P04508)(COMPLETED)

Study Overview
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Brief Summary
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In patients with chronic hepatitis C, the ultimate treatment goal is the improvement of liver histology and inhibition of progression to liver cirrhosis and hepatocellular carcinoma (HCC). These effects are reported to be correlated with sustained ALT improvement. Therefore, the aim of this study is to determine if a low-dose (0.25, 0.5, or 1.0 mcg/kg SC QW) PegIntron monotherapy administered for 12 weeks will result in ALT normalization in Japanese patients with chronic hepatitis C.

Official Title
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Study to Confirm Dose Response With PegIntron (SCH 54031) Monotherapy in Patients With Chronic Hepatitis C

Conditions
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Hepatitis C, Chronic, Hepatitis C

Intervention / Treatment
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* Biological: PegIntron (peginterferon alfa-2b)
* Biological: PegIntron (peginterferon alfa-2b)
* Biological: PegIntron (peginterferon alfa-2b)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic hepatitis C patients (CHC) who met all of the following criteria: At least 20 years of age and willing to sign an informed consent Patients who can practice contraception Patients who are classified either as relapsers or non-responders. Weight between 45 and 100 kg Patients willing to be hospitalized for 3 days after the start of treatment Patients with positive HCV-RNA Serum ALT level: Over 60 IU/L, equal to or less than 150 IU/L Neutrophil count: equal to or more than 1,200 /mm^3 Platelet count：equal to or more than 100,000/mm^3 Exclusion Criteria: Patients with conditions which would interfere with the evaluation of therapeutic efficacy of the study drug and patients for whom assurance of safety is a concern were excluded from the study.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.25 Dose Group<br>PegIntron 0.25 mcg/kg SC QW for 12 weeks | Biological: PegIntron (peginterferon alfa-2b)<br>* PegIntron 0.25 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks<br>* Other names: PegIntron, peginterferon alfa-2b, SCH 54031;|
| Experimental: 0.5 Dose Group<br>PegIntron 0.5 mcg/kg SC QW for 12 weeks | Biological: PegIntron (peginterferon alfa-2b)<br>* PegIntron 0.5 mcg/kg SC QW for 12 weeks<br>* Other names: PegIntron, peginterferon alfa-2b, SCH 54031;|
| Experimental: 1.0 Dose Group<br>PegIntron 1.0 mcg/kg SC QW for 12 weeks | Biological: PegIntron (peginterferon alfa-2b)<br>* PegIntron 1.0 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks<br>* Other names: PegIntron, peginterferon alfa-2b, SCH 54031;|
| No Intervention: No-treatment Control<br>No treatment (no placebo) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who achieve normalization of ALT in each treatment group |  | Measured at the end of 12 weeks of treatment or at discontinuation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: adverse events, adverse reactions, laboratory test result (hematology, blood biochemistry and thyroid function test) |  | Measured between when the patient signs the informed consent form and the end of post-treatment follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alanine transaminase