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

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ClinicalTrials.gov Identifier: NCT00787371
Recruitment Status : Completed
First Posted : November 7, 2008
Last Update Posted : March 13, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Hepatitis C Biological: PegIntron (peginterferon alfa-2b) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study to Confirm Dose Response With PegIntron (SCH 54031) Monotherapy in Patients With Chronic Hepatitis C
Study Start Date : June 2005
Primary Completion Date : July 2006
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 0.25 Dose Group
PegIntron 0.25 mcg/kg SC QW for 12 weeks
Biological: PegIntron (peginterferon alfa-2b)
PegIntron 0.25 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks
Other Name: PegIntron, peginterferon alfa-2b, SCH 54031
Experimental: 0.5 Dose Group
PegIntron 0.5 mcg/kg SC QW for 12 weeks
Biological: PegIntron (peginterferon alfa-2b)
PegIntron 0.5 mcg/kg SC QW for 12 weeks
Other Name: PegIntron, peginterferon alfa-2b, SCH 54031
Experimental: 1.0 Dose Group
PegIntron 1.0 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
Other Name: PegIntron, peginterferon alfa-2b, SCH 54031
No Intervention: No-treatment Control
No treatment (no placebo)

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00787371     History of Changes
Other Study ID Numbers: P04508
First Posted: November 7, 2008    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017

Keywords provided by Merck Sharp & Dohme Corp.:
alanine transaminase

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs