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)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PegIntron (peginterferon alfa-2b; SCH 54031)

Drug

PegIntron administered in accordance with approved labeling

Subcutaneous injection once weekly for 24 weeks.

Other names: SCH 54031

REBETOL (ribavirin; SCH 18908)

Drug

Rebetol administered orally twice daily in accordance with approved labeling. Dosing duration 24 weeks.

Other names: SCH 18908

Primary outcomes

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

Time frame: Assessed at 24 weeks post-treatment

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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"-

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Jul 29, 2008
Registry last updated: Feb 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed