Effect of Low-Dose PegIntron on ALT Normalization in Japanese Patients With Chronic Hepatitis C (Study P04508)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
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
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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 2 |
| 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:
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 May 21, 2013