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Completed

NCT Number: NCT01604291

An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C

This multi-center, observational study will evaluate the efficacy and safety of dual and triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to 24 weeks of follow-up.

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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

Haemek Hospital; Gastroenterology, Afula, Israel

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, >/= 18 years of age
  • Chronic hepatitis C (all genotypes, naïve or treatment experienced, HCV mono-infected or HCV-HIV co-infected)
  • Receiving either dual therapy (Pegasys plus ribavirin) or triple therapy (Pegasys plus ribavirin plus telaprevir/boceprevir)
  • No contra-indications to Pegasys and ribavirin therapy or to treatment regimen containing protease inhibitor (telaprevir or boceprevir) as detailed in local Prescribing Information
  • Quantitative serum HCV RNA by PCR test before initiation of treatment

Exclusion criteria

  • Hepatitis A/B co-infection
  • Evidence of severe illness, active malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • Pregnant or breast-feeding women

Treatment and study plan

Primary outcomes

  1. Percentage of Participants With Sustained Viral Response (SVR) at Week 24

    Time frame: Week 24

    The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels < 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion.

Secondary outcomes

  1. Comparison of SVR at Week 24

    Time frame: Week 24

    SVR at Week 24 is compared by treatment group, type of infection, prior treatments and genotype.

  2. Number of Participants With SVR at Week 24 According to the Demographic Characteristics

    Time frame: Week 24

    The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels < 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion. Number of participants analysed signifies participants who were evaluated for outcome measure. Data for this outcome measure was not summarized for each arm. Hence, data is reported for all participants.

  3. Percentage of Participants With Rapid Virologic Response (RVR) at Week 4

    Time frame: Week 4

    RVR was defined as HCV-RNA <50 IU/mL by Week 4

  4. Percentage of Participants With Extended RVR

    Time frame: Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group

    Extended RVR was defined as HCV-RNA <50 IU/mL at weeks 4 and 12 for participants treated with telaprevir; or at weeks 8 & 24 for participants treated with boceprevir.

    The assessment was performed in participants who received triple therapy in treatment arms 'Peginterferon Alfa-2a + Ribavirin +Telaprevir' and 'Peginterferon Alfa-2a + Ribavirin + Boceprevir'.

  5. Percentage of Participants With Complete Early Virologic Response (cEVR)

    Time frame: Week 12

    Complete early virologic response (cEVR) was defined as HCV-RNA <50 IU/mL by Week 12

  6. Percentage of Participants With End of Treatment Response (EoT)

    Time frame: Week 24

    End-of-Treatment (EoT) response was defined as HCV-RNA <50 IU/mL by the end of treatment.

  7. Percentage of Participants With Virologic Relapse

    Time frame: Week 72

    Virologic relapse was defined as detectable HCV-RNA during the treatment-free follow-up period in participants with HCV-RNA <50 IU/mL at EoT.

  8. Treatment Duration

    Time frame: Week 48

    The average amount of time a treatment was prescribed to participants.

  9. Time to First Dose Modification of Peginterferon Alfa-2a

    Time frame: Week 48

  10. Time to First Dose Modification of Ribavirin

    Time frame: Week 48

  11. Time to First Dose Modification of Telaprevir/Boceprevir

    Time frame: Week 48

  12. Percentage of Participants With Adverse Events (AEs)

    Time frame: Week 48

    Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Safety analysis included 2 additional participants in arm 'Peginterferon Alfa-2a + Ribavirin + Telaprevir'. The safety parameters were analyzed by the treatment actually received by the participants.

  13. Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia

    Time frame: Week 48

  14. Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia

    Time frame: Week 48

  15. Percentage of Participants Who Had SVR at Week 24 With Dose Modifications

    Time frame: Week 24

    Participants with dose modifications who had achieved SVR at Week 24 were reported. Data was collected for all participants who had dose modification of Peginterferon alfa-2a, Ribavirin or Telaprevir/boceprevir in any of the treatment regimen during the study.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • Clalit Health Services

Registry information

Official study title

Multi-Center, Non-Interventional Study, on the Efficacy of Dual and Triple Therapies Based on Pegylated Interferon Alfa-2a for the Treatment of Chronic Hepatitis C Patients

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 23, 2012
Registry last updated
Mar 14, 2019

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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