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OpenTrials
Completed

NCT Number: NCT02515279

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

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

A.Ö. Krankenhaus Der Barmherzigen Schwestern Ried; Interne Abtl.

Ried-innkreis, 4910, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • None specified

Treatment and study plan

Peginterferon alfa-2a

Drug

180 micrograms subcutaneous weekly for 48 weeks.

Other names: Pegasys

Ribavirin

Drug

1000-1600 mg day orally for 48 weeks.

Other names: Copegus

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Non-Interventional Trial of Pegasys/Copegus in HCV Patients for 12 Months

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Aug 4, 2015
Registry last updated
Apr 10, 2017

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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