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

NCT00787371 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2017-03-13

No results posted yet for this study

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.

Conditions

  • Hepatitis C, Chronic
  • Hepatitis C

Interventions

BIOLOGICAL

PegIntron (peginterferon alfa-2b)

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

BIOLOGICAL

PegIntron (peginterferon alfa-2b)

PegIntron 0.5 mcg/kg SC QW for 12 weeks

BIOLOGICAL

PegIntron (peginterferon alfa-2b)

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2006-07-31
Completion
2006-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00787371 on ClinicalTrials.gov