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

This study has been completed.

Sponsor:

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00787371

First received: November 6, 2008

Last updated: NA

Last verified: November 2008

History: No changes posted

Tracking Information
First Received Date ^ICMJE	November 6, 2008
Last Updated Date	November 6, 2008
Start Date ^ICMJE	June 2005
Primary Completion Date	July 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 6, 2008)	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. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: November 6, 2008)	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 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Low-Dose PegIntron on ALT Normalization in Japanese Patients With Chronic Hepatitis C (Study P04508)(COMPLETED)
Official Title ^ICMJE	Study to Confirm Dose Response With PegIntron (SCH 54031) Monotherapy in Patients With Chronic Hepatitis C
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hepatitis C, Chronic Hepatitis C
Intervention ^ICMJE	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 Biological: PegIntron (peginterferon alfa-2b) PegIntron 0.5 mcg/kg SC QW for 12 weeks Other Name: PegIntron, peginterferon alfa-2b, SCH 54031 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
Study Arm (s)	Experimental: 0.25 Dose Group PegIntron 0.25 mcg/kg SC QW for 12 weeks Intervention: Biological: PegIntron (peginterferon alfa-2b) Experimental: 0.5 Dose Group PegIntron 0.5 mcg/kg SC QW for 12 weeks Intervention: Biological: PegIntron (peginterferon alfa-2b) Experimental: 1.0 Dose Group PegIntron 1.0 mcg/kg SC QW for 12 weeks Intervention: Biological: PegIntron (peginterferon alfa-2b) No Intervention: No-treatment Control No treatment (no placebo)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	69
Completion Date	July 2006
Primary Completion Date	July 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	20 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00787371
Other Study ID Numbers ^ICMJE	P04508, JPC-04-356-20
Has Data Monitoring Committee	No
Responsible Party	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	November 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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