Quantification of Side Effects During Hepatitis C Therapy
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|ClinicalTrials.gov Identifier: NCT02545400|
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : October 5, 2015
|Condition or disease|
Hepatitis C Virus infection is one of the main causes of chronic liver disease worldwide with current estimates of approximately 130 - 210 million individuals (according to 3% of the world population) chronically infected with the hepatitis C virus. However, hepatitis C virus infections are among the most common causes leading to chronic hepatitis, liver cirrhosis and liver related death worldwide.
The current standard of care is a combination of pegylated Interferon and Ribavirin (dual-therapy). Since 2011, direct-acting antiviral drugs inhibiting viral protease are approved as an addition to the standard therapy (triple-therapy).
The occurrence of adverse events as well as their severity generally depends on the therapy regimen and is influenced by type and dosage of medications.
Most common adverse events (affects up to 95% of patients) are fever, fatigue, headache, nausea, arthralgia, depression, skin reactions, neutropenia, and anemia.
A more frequent occurrence of adverse events with triple-therapy compared to dual- therapy has become clear since it's introduction, particularly with regard to anemia, neutropenia, gastrointestinal discomfort, fatigue, dysgeusia, and skin reactions. How- ever, there is accumulating evidence for a more often appearance of infections and/or infestations in patients receiving triple-therapy.
The medical consequence from adverse events is a reduction of quality of life and consecutively the loss of antiviral therapy adherence. Thus, early recognition and immediate treatment of adverse events are crucial aspects in the success of antiviral treatment.
Aim of this study is to quantify reported adverse events with respect to therapy reg- imen (dual-therapy vs. triple-therapy) in patients who are treated at the Department of Internal Medicine, Division of Gastroenterology and Hepatology at the Medical University Graz. Furthermore, a detailed review of international treatment recommendations, as well as an analysis of possible predictor parameters for the appearance of adverse events and treatment success is done.
|Study Type :||Observational|
|Actual Enrollment :||108 participants|
|Official Title:||Quantification of Side Effects During Dual or Triple Therapy for Chronic Hepatitis C|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2015|
- frequency of adverse events [ Time Frame: on average 24 weeks ]reported adverse events
- type of adverse events [ Time Frame: on average 24 weeks ]reported adverse events
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545400
|Department of Internal Medicine, Medical University of Graz|
|Graz, Austria, 8010|
|Principal Investigator:||Vanessa Stadlbauer, MD||Medical University of Graz|