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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00724230|
Recruitment Status : Completed
First Posted : July 29, 2008
Last Update Posted : February 3, 2015
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.
|Condition or disease||Intervention/treatment|
|Hepatitis C, Chronic Hepatitis C||Drug: PegIntron (peginterferon alfa-2b; SCH 54031) Drug: Rebetol (ribavirin; SCH 18908)|
|Study Type :||Observational|
|Actual Enrollment :||505 participants|
|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 Start Date :||February 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Overall study population.
Drug: PegIntron (peginterferon alfa-2b; SCH 54031)
PegIntron administered in accordance with approved labeling
Subcutaneous injection once weekly for 24 weeks.
Other Name: SCH 54031
Drug: Rebetol (ribavirin; SCH 18908)
Rebetol administered orally twice daily in accordance with approved labeling. Dosing duration 24 weeks.
Other Name: SCH 18908
- 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 ]
- 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 ]