Effect of Low-dose PegIntron on ALT Normalization in Japanese Patients With Chronic Hepatitis C (Study P04508)(COMPLETED)
March 8, 2017 updated by: Merck Sharp & Dohme LLC
Study to Confirm Dose Response With PegIntron (SCH 54031) Monotherapy in Patients With Chronic Hepatitis C
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 0.25 Dose Group
PegIntron 0.25 mcg/kg SC QW for 12 weeks
|
PegIntron 0.25 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks
Other Names:
PegIntron 0.5 mcg/kg SC QW for 12 weeks
Other Names:
PegIntron 1.0 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks
Other Names:
|
|
Experimental: 0.5 Dose Group
PegIntron 0.5 mcg/kg SC QW for 12 weeks
|
PegIntron 0.25 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks
Other Names:
PegIntron 0.5 mcg/kg SC QW for 12 weeks
Other Names:
PegIntron 1.0 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks
Other Names:
|
|
Experimental: 1.0 Dose Group
PegIntron 1.0 mcg/kg SC QW for 12 weeks
|
PegIntron 0.25 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks
Other Names:
PegIntron 0.5 mcg/kg SC QW for 12 weeks
Other Names:
PegIntron 1.0 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks
Other Names:
|
|
No Intervention: No-treatment Control
No treatment (no placebo)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
|
Measured at the end of 12 weeks of treatment or at discontinuation.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Measured between when the patient signs the informed consent form and the end of post-treatment follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
July 1, 2006
Study Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
November 6, 2008
First Submitted That Met QC Criteria
November 6, 2008
First Posted (Estimate)
November 7, 2008
Study Record Updates
Last Update Posted (Actual)
March 13, 2017
Last Update Submitted That Met QC Criteria
March 8, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Immunologic Factors
- Interferon-alpha
- Peginterferon alfa-2b
Other Study ID Numbers
- P04508
- JPC-04-356-20
Plan for Individual participant data (IPD)
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.