NCT00787371CompletedPhase 2
Study to Confirm Dose Response With PegIntron (SCH 54031) Monotherapy in Patients With Chronic Hepatitis C
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 69
- Primary Endpoint
- Percentage of patients who achieve normalization of ALT in each treatment group
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
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 Outcomes
- Safety: adverse events, adverse reactions, laboratory test result (hematology, blood biochemistry and thyroid function test)(Measured between when the patient signs the informed consent form and the end of post-treatment follow-up)
Investigators
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