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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00787371

Enrollment

Registered

2008-11-07

Start date

2005-06-30

Completion date

2006-07-31

Last updated

2017-03-13

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

Conditions

Hepatitis C, Hepatitis C, Chronic

Keywords

alanine transaminase

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.

Interventions

BIOLOGICALPegIntron (peginterferon alfa-2b)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	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

Outcome results

None listed

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