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

Hepatitis C Clinical Trial

Official title:

Study to Confirm Dose Response With PegIntron (SCH 54031) Monotherapy in Patients With Chronic Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00787371
• Other study ID #: P04508
• Secondary ID: JPC-04-356-20
• Status: Completed
• Phase: Phase 2
• First received: November 6, 2008
• Last updated: March 8, 2017
• Start date: June 2005
• Est. completion date: July 2006

Study information

• Verified date: March 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• PegIntron (peginterferon alfa-2b)
PegIntron 0.25 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks
• PegIntron (peginterferon alfa-2b)
PegIntron 0.5 mcg/kg SC QW for 12 weeks
• PegIntron (peginterferon alfa-2b)
PegIntron 1.0 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who achieve normalization of ALT in each treatment group		Measured at the end of 12 weeks of treatment or at discontinuation.
Secondary	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