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An Observational Study of Peginterferon Alfa-2a Plus Ribavirin for Hepatitis C Virus (HCV) Infection in Austria

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: NCT02515279
Recruitment Status : Completed
First Posted : August 4, 2015
Results First Posted : February 10, 2016
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This noninterventional, open-label study will observe the safety and tolerability of peginterferon alfa-2a in combination with ribavirin among Austrian participants treated for HCV infection according to routine practice.

Condition or disease Intervention/treatment
Hepatitis C Drug: Peginterferon alfa-2a Drug: Ribavirin

Study Design
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Study Type : Observational
Actual Enrollment : 463 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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

Drug: Ribavirin
1000-1600 mg day orally for 48 weeks.
Other Name: Copegus


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will enroll Austrian participants receiving peginterferon alfa-2a and ribavirin for HCV infection according to routine practice.
Criteria

Inclusion Criteria:

  • Ongoing treatment with peginterferon alfa-2a and ribavirin at the discretion of the prescribing physician
  • HCV infection

Exclusion Criteria:

  • None specified
Contacts and Locations
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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): NCT02515279


Locations
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Austria
A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl.
Ried-innkreis, Austria, 4910
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02515279    
Other Study ID Numbers: ML22273
First Posted: August 4, 2015    Key Record Dates
Results First Posted: February 10, 2016
Last Update Posted: April 10, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents