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Quantification of Side Effects During Hepatitis C Therapy

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: NCT02545400
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : October 5, 2015
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

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

Condition or disease
Hepatitis C

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. frequency of adverse events [ Time Frame: on average 24 weeks ]
    reported adverse events


Secondary Outcome Measures :
  1. type of adverse events [ Time Frame: on average 24 weeks ]
    reported adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic hepatitis C undergoing therapy with pegylated interferon and ribavirin +/- a firstgeneration protease inhibitor
Criteria

Inclusion Criteria:

  • chronic hepatitis C
  • Indication for a hepatitis C therapy

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545400


Locations
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Austria
Department of Internal Medicine, Medical University of Graz
Graz, Austria, 8010
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Vanessa Stadlbauer, MD Medical University of Graz

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT02545400     History of Changes
Other Study ID Numbers: HCV-side effects
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections