An Observational Study of Peginterferon Alfa-2a Plus Ribavirin for Hepatitis C Virus (HCV) Infection in Austria
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|ClinicalTrials.gov Identifier: NCT02515279|
Recruitment Status : Completed
First Posted : August 4, 2015
Results First Posted : February 10, 2016
Last Update Posted : April 10, 2017
|Condition or disease||Intervention/treatment|
|Hepatitis C||Drug: Peginterferon alfa-2a Drug: Ribavirin|
|Study Type :||Observational|
|Actual Enrollment :||463 participants|
|Official Title:||A Non-Interventional Trial of Pegasys/Copegus in HCV Patients for 12 Months|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Participants With Hepatitis C
All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
Drug: Peginterferon alfa-2a
180 micrograms subcutaneous weekly for 48 weeks.
Other Name: Pegasys
1000-1600 mg day orally for 48 weeks.
Other Name: Copegus
- Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) [ Time Frame: Up to 6 years ]An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs.
- Percentage of Participants With End of Treatment Response [ Time Frame: 12 months ]Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). A participant was considered to have and end of treatment response if there was undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) after completing treatment. Participants with available PCR results were reported.
- Percentage of Participants With Sustained Virologic Response 24 (SVR24) [ Time Frame: 18 months ]Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). SVR24 is defined as the percentage of participants with undetectable HCV RNA 24 weeks after completing treatment.
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): NCT02515279
|A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl.|
|Ried-innkreis, Austria, 4910|
|Study Director:||Clinical Trials||Hoffmann-La Roche|