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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)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic; Hepatitis C

Intervention: PegIntron (peginterferon alfa-2b; SCH 54031) (Drug); Rebetol (ribavirin; SCH 18908) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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.

Clinical Details

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"-

Study design: Time Perspective: Prospective

Primary outcome:

Overall incidence of adverse events and adverse drug reactions.

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

Sustained virologic response rate by HCV genotype, baseline viral load, and patient demographic characteristics

Secondary outcome: Rate of ALT normalization at end of treatment period and at 24 weeks post completing therapy.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: February 2006
Last updated: February 2, 2015

Page last updated: August 20, 2015

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