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Completed

NCT Number: NCT00787371

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

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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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PegIntron (Peginterferon alfa-2b)

Biological

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

Other names: PegIntron, peginterferon alfa-2b, SCH 54031

Primary outcomes

  1. Percentage of patients who achieve normalization of ALT in each treatment group

    Time frame: Measured at the end of 12 weeks of treatment or at discontinuation.

Secondary outcomes

  1. Safety: adverse events, adverse reactions, laboratory test result (hematology, blood biochemistry and thyroid function test)

    Time frame: Measured between when the patient signs the informed consent form and the end of post-treatment follow-up

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Nov 7, 2008
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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