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

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ClinicalTrials.gov Identifier: NCT02556307
Recruitment Status : Completed
First Posted : September 22, 2015
Results First Posted : February 15, 2016
Last Update Posted : February 15, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

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

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Study Type : Observational
Actual Enrollment : 270 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : March 2009
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Peginterferon alfa-2a + Ribavirin Drug: Peginterferon alfa-2a
Peginterferon alfa-2a according to the standard practice in line with current summaries \nof product characteristics (SPCs)/local labeling.
Other Name: Pegasys

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Slovenian patients with chronic hepatitis C (CHC) treated with Peginterferon alfa-2a and ribavirin.
Criteria

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

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): NCT02556307


Locations
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Slovenia
Celje, Slovenia, 3000
Ljubljana, Slovenia, 1000
Maribor, Slovenia, 2000
Novo Mesto, Slovenia, 8000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02556307     History of Changes
Other Study ID Numbers: ML22263
First Posted: September 22, 2015    Key Record Dates
Results First Posted: February 15, 2016
Last Update Posted: February 15, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs