Safety and Efficacy of PegIntron Plus Rebetol in Patients With Chronic Hepatitis C in Japan, Excluding (1) Subjects With HCV Genotype 1 and High Viral Load, and (2) Interferon-naïve Subjects With Low Viral Load (Study P04841)(COMPLETED)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00724230
• Date of registration: 25/07/2008
• Primary sponsor: Schering-Plough
• Public title: Safety and Efficacy of PegIntron Plus Rebetol in Patients With Chronic Hepatitis C in Japan, Excluding (1) Subjects With HCV Genotype 1 and High Viral Load, and (2) Interferon-naïve Subjects With Low Viral Load (Study P04841)(COMPLETED)
• Scientific title: PegIntron/REBETOL Combination Therapy Designated Drug Use Investigation -Investigation on the Safety and Efficacy of PegIntron and REBETOL Combination Therapy in Patients With Chronic Hepatitis C Excluding Those With "IFN Naive Low Viral Load and Genotype 1 and High Viral Load"-
• Date of first enrolment: February 2006
• Target sample size: 500
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00724230
• Study type: Observational
• Study design: Time Perspective: Prospective

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients diagnosed with chronic hepatitis C

- Among interferon-naïve patients, only patients with high viral load and HCV genotype
other than 1

- Among prior nonresponders or relapsers to interferon monotherapy, (1) patients with
high viral load and HCV genotype other than 1; and (2) patients with low viral load
of all genotypes (including genotype 1)

Exclusion Criteria:

- Patients infected with HCV genotype 1 with high viral load, regardless of whether
treatment-naïve or previous nonresponders/relapsers

- Interferon-naïve patients with low viral load

- 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



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis C

Hepatitis C, Chronic

Intervention(s)

Drug: PegIntron (peginterferon alfa-2b; SCH 54031)

Drug: Rebetol (ribavirin; SCH 18908)

Primary Outcome(s)

Assessment of trends of adverse drug reactions by patient factors and concomitant medications; Incidence, severity, and outcome of adverse events (AEs) between the elderly vs younger patients [Time Frame: Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study]

Overall incidence of adverse events and adverse drug reactions. [Time Frame: Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study]

Sustained virologic response rate by HCV genotype, baseline viral load, and patient demographic characteristics [Time Frame: Assessed at 24 weeks post-treatment]

Secondary Outcome(s)

Rate of ALT normalization at end of treatment period and at 24 weeks post completing therapy. [Time Frame: End of treatment and 24 weeks after end of treatment]

Secondary ID(s)

P04841

Source(s) of Monetary Support

Please refer to primary and secondary sponsors