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NCT Number: NCT02556307

A Study of the Effectiveness of Peginterferon Alfa-2a (Pegasys) and Ribavirin Treatment in Slovenian Hepatitis C (HCV) Patients

In this Slovenian, multi-center, observational study, the effectiveness of standard of care Peginterferon alfa-2a + ribavirin treatment in adult patients with chronic hepatitis C (CHC) is examined. Patients were treated for 24- or 48-weeks, as prescribed by the treating physician, followed by a 24-week follow-up period.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Celje, Slovenia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female patients >/= 18 years
  • Positive test for HCV
  • Effective contraception as specified by the Peginterferon alfa-2a and/or ribavirin labels

Exclusion criteria

  • Concomitant infection with HIV or hepatitis B
  • Participation in a clinical trial within 30 days prior to study start
  • Any contraindications specified in the Peginterferon alfa-2a and ribavirin product labels

Treatment and study plan

Peginterferon alfa-2a

Drug

Peginterferon alfa-2a according to the standard practice in line with current summaries \\nof product characteristics (SPCs)/local labeling.

Other names: Pegasys

Ribavirin

Drug

Ribavirin according to the standard practice in line with current summaries \\nof product characteristics (SPCs)/local labeling.

Other names: Copegus

Primary outcomes

  1. Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment

    Time frame: 6 months after the last study drug administration (up to 123.6 weeks)

    SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment).

Secondary outcomes

  1. Percentage of Participants With Undetectable HCV RNA

    Time frame: Weeks 4, 12 and at end of treatment (up to 99.6 weeks)

    Undetectable HCV RNA=a single last HCV RNA <20 IU/mL

  2. HCV RNA Values

    Time frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

  3. Thrombocyte Values

    Time frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

  4. Leukocyte Values

    Time frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

  5. Hemoglobin Values

    Time frame: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

  6. Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin

    Time frame: Up to 99.6 Weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Sep 22, 2015
Registry last updated
Feb 15, 2016

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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