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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-07-31

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.

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Detailed Description

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Conditions

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Hepatitis C, Chronic Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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0.25 Dose Group

PegIntron 0.25 mcg/kg SC QW for 12 weeks

Group Type EXPERIMENTAL

PegIntron (peginterferon alfa-2b)

Intervention Type BIOLOGICAL

PegIntron 0.25 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks

0.5 Dose Group

PegIntron 0.5 mcg/kg SC QW for 12 weeks

Group Type EXPERIMENTAL

PegIntron (peginterferon alfa-2b)

Intervention Type BIOLOGICAL

PegIntron 0.5 mcg/kg SC QW for 12 weeks

1.0 Dose Group

PegIntron 1.0 mcg/kg SC QW for 12 weeks

Group Type EXPERIMENTAL

PegIntron (peginterferon alfa-2b)

Intervention Type BIOLOGICAL

PegIntron 1.0 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks

No-treatment Control

No treatment (no placebo)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PegIntron (peginterferon alfa-2b)

PegIntron 0.25 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks

Intervention Type BIOLOGICAL

PegIntron (peginterferon alfa-2b)

PegIntron 0.5 mcg/kg SC QW for 12 weeks

Intervention Type BIOLOGICAL

PegIntron (peginterferon alfa-2b)

PegIntron 1.0 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks

Intervention Type BIOLOGICAL

Other Intervention Names

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PegIntron, peginterferon alfa-2b, SCH 54031 PegIntron, peginterferon alfa-2b, SCH 54031 PegIntron, peginterferon alfa-2b, SCH 54031

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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No