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

Phase 2

Completed

• Conditions: Hepatitis C, Chronic; Hepatitis C
• Interventions: Biological: PegIntron (peginterferon alfa-2b)

• Registration Number: NCT00787371
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Study First Submitted: 2008-11-06
• Study First Submitted QC: 2008-11-06
• Study First Posted: 2008-11-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-08
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.0 Dose Group	PegIntron (peginterferon alfa-2b)	PegIntron 1.0 mcg/kg SC QW for 12 weeks
0.25 Dose Group	PegIntron (peginterferon alfa-2b)	PegIntron 0.25 mcg/kg SC QW for 12 weeks
0.5 Dose Group	PegIntron (peginterferon alfa-2b)	PegIntron 0.5 mcg/kg SC QW for 12 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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