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

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00787371

Purpose

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	Intervention	Phase
Hepatitis C, Chronic Hepatitis C	Biological: PegIntron (peginterferon alfa-2b)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Study to Confirm Dose Response With PegIntron (SCH 54031) Monotherapy in Patients With Chronic Hepatitis C

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Peginterferon Alfa-2b

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	69
Study Start Date:	June 2005
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00787371 History of Changes
Other Study ID Numbers:	P04508, JPC-04-356-20
Study First Received:	November 6, 2008
Last Updated:	November 6, 2008
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Schering-Plough:

alanine transaminase

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
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
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012