Safety and Efficacy of PegIntron and Rebetol Combination Therapy in Patients With Chronic Hepatitis C in Japan (Study P04505)

NCT00724295 | Completed

• 1 other identifier: P04505
• Study Type: observational
• Target: 1,077
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a post-marketing surveillance of patients with chronic hepatitis C treated with PegIntron and Rebetol combination therapy in clinical practice in Japan. The objective of the study is to evaluate the safety and efficacy of the combination therapy. The study will also compare the safety profile of the combination therapy among elderly patients and younger patients. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Conditions

Hepatitis C, Chronic; Hepatitis C

Outcome Measures

Primary Outcomes (3)

• Overall incidence of adverse events and adverse drug reactions.

  From the time the informed consent is signed and up to 30 days after study completion or discontinuation. Treatment period is 48 weeks with a 24 week post dose followup.

• Assessment of trends of adverse drug reactions by patient factors and concomitant medications. Incidence of adverse events (AEs) in the elderly vs younger patients; rates of hematologic AEs; dose reduction and discontinuation rates.

  From the time the informed consent is signed and up to 30 days after study completion or discontinuation. Treatment period is 48 weeks with a 24 week post dose followup.

• Sustained virologic response rate and improvement of ALT (alanine transaminase).

  Assessed at the end-of-treatment and at 24 weeks post-treatment.

Study Arms (1)

Arm 1

Overall study population

Drug: peginterferon alfa-2b; Drug: ribavirin

Interventions

peginterferon alfa-2b DRUG

PegIntron powder (reconstituted) administered in accordance with approved labeling; Subcutaneous injection of 1.5 ug/kg once weekly for 48 weeks.

Also known as: PegIntron, SCH 54031

Arm 1

ribavirin DRUG

Rebetol capsule administered orally twice daily in accordance with approved labeling (weight based dosing). Dosing duration 48 weeks.

Also known as: Rebetol, SCH 18908

Arm 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic hepatitis C treated with PegIntron and Rebetol combination therapy in the clinical practice at approximately 100 to 200 institutions in Japan.

You may qualify if:

• Patients with chronic hepatitis C.
• Patients are serogroup 1(genotype I (1a) or II (1b)).
• The HCV-RNA level in the blood is more than 10\^5 IU/mL by RT-PCR method, or 1Meq./mL by b-DNA method

You may not qualify if:

• Patients with a history of hypersensitivity to test drugs or other interferon preparations
• Patients with a history of hypersensitivity to biological products, such as vaccines
• Patients being treated with Shosaikoto
• Patients with autoimmune hepatitis
• Pregnant women, women who may be pregnant, and nursing mothers
• Patients with a history of hypersensitivity to any component of this drug or other nucleoside analogs (aciclovir, ganciclovir, vidarabine, etc.)
• Patients with difficult-to-control cardiac disease (eg, myocardial infarction, cardiac failure, arrhythmia)
• Patients with hemoglobinopathies (eg, thalassemia, sickle-cell anemia)
• Patients with chronic renal failure or renal function disorder with creatinine clearance of \<=50 mL/min
• Patients with or a history of severe psychiatric condition such as severe depression, suicidal ideation or suicide attempt
• Patients with serious hepatic dysfunction
• Patients with autoimmune hepatitis

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

peginterferon alfa-2b; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: April 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 4, 2015

Record last verified: 2015-02