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)

Hepatitis C Clinical Trial

Official 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"-

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724230
• Other study ID #: P04841
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: February 2, 2015
• Start date: February 2006
• Est. completion date: December 2008

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial Summary

The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C. The study will exclude (1) subjects with HCV genotype 1 and high viral load, and (2) interferon-naïve subjects with low viral load. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Drug:
• PegIntron (peginterferon alfa-2b; SCH 54031)
PegIntron administered in accordance with approved labeling Subcutaneous injection once weekly for 24 weeks.
• Rebetol (ribavirin; SCH 18908)
Rebetol administered orally twice daily in accordance with approved labeling. Dosing duration 24 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	Overall incidence of adverse events and adverse drug reactions.		Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study	Yes
Primary	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		Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study	Yes
Primary	Sustained virologic response rate by HCV genotype, baseline viral load, and patient demographic characteristics		Assessed at 24 weeks post-treatment	No
Secondary	Rate of ALT normalization at end of treatment period and at 24 weeks post completing therapy.		End of treatment and 24 weeks after end of treatment	No