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Completed

NCT Number: NCT02545400

Quantification of Side Effects During Hepatitis C Therapy

This study aims to assess the frequency and severity of adverse events during Hepatitis C therapy with or without first generation protease inhibitors.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Internal Medicine, Medical University of Graz

Graz, 8010, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • chronic hepatitis C
  • Indication for a hepatitis C therapy

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. frequency of adverse events

    Time frame: on average 24 weeks

    reported adverse events

Secondary outcomes

  1. type of adverse events

    Time frame: on average 24 weeks

    reported adverse events

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Quantification of Side Effects During Dual or Triple Therapy for Chronic Hepatitis C

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Sep 10, 2015
Registry last updated
Oct 5, 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.

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