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An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01447446
First received: October 4, 2011
Last updated: February 10, 2017
Last verified: December 2016

October 4, 2011
February 10, 2017
September 2011
July 2015   (Final data collection date for primary outcome measure)
  • Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24) [ Time Frame: 24 weeks after end of treatment (up to 118 weeks) ]
    SVR24 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 24 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR24 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 24 weeks post completion of the treatment period.
  • Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12) [ Time Frame: 12 weeks after end of treatment (up to 118 weeks) ]
    SVR12 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR12 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 weeks post completion of the treatment period.
Sustained virological response rate, defined as percentage of patients with HCV RNA <50 IU/mL at 24 weeks past completion of treatment [ Time Frame: approximately 4 years ]
Complete list of historical versions of study NCT01447446 on ClinicalTrials.gov Archive Site
  • Virological Response at Various on Treatment Time Points and End of Treatment (EOT) [ Time Frame: Week 4, 12 and End of treatment (EOT) (up to 96 weeks) ]
    Virological response (VR) for dual therapy participants is defined as HCV RNA <50 IU/mL as assessed by a qualitative HCV RNA test with a lower limit of detection (LLD) <=50 IU/mL or as assessed by a quantitative test with a lower limit of quantification (LLQ) <=50 IU/mL for all time points concerned. Results of HCV RNA tests with LLD and LLQ >50 IU/mL were considered as non-response. VR for triple therapy participants is defined as undetectable HCV RNA assessed by a test with lower limit of detection <=50 IU/mL (UVR). Results of HCV RNA tests with an LLD >50 IU/mL were considered as non-response for triple therapy participants.
  • Virological Relapse After End of Treatment [ Time Frame: Up to 24 weeks after EOT (up to 118 weeks) ]
    Virological relapse defined as non-virological response (non-VR)/non-undetectable virological response (non-UVR) at the last HCV RNA assessment during the treatment-free follow-up period in participants with VR/UVR at EOT. Here, number of participants analyzed is the participants with end of treatment response (EoT-R) who also had an HCV RNA test at least 12 weeks after EoT or whose last follow-up HCV RNA test showed non-response (HCV RNA >=50 IU/mL).
  • Virological Breakthrough [ Time Frame: Up to EOT (up to 118 weeks) ]
    Virological breakthrough/rebound defined as non-VR/non-UVR during the treatment period (including end of treatment) in participants with prior VR/UVR or an increase of HCV RNA by >=1 log10 during the treatment period in comparison to the lowest HCV RNA (nadir) previously measured during the treatment period in participants without VR/UVR during the treatment period. Here, Number of participants analyzed is the participants with at least 2 on-treatment HCV RNA assessments (including EoT) or 1 on-treatment HCV RNA assessment (excluding EoT) and response at EoT by backward imputation.
  • Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions [ Time Frame: Up to first 12 weeks of treatment ]
    SVR 12 and 24 rates for dual therapy participants are defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 or 24 weeks post completion of the treatment period. If a qualitative test was used, then the lower limit of detection has to be <=50 IU/mL. SVR12 and 24 rates for triple therapy participants are defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 or 24 weeks post completion of the treatment period. Here, number of participants analyzed excluded the participants with premature withdrawal due to lack of efficacy or non-safety reasons and participants without dose reductions or interruptions during the first 99 study days.
  • Percentage of Participants With Very Rapid Virological Response, Rapid Virological Response, Complete Early Virological Response and Partial Early Virological Response (pEVR) During First 12 Weeks [ Time Frame: Up to 12 weeks ]
    Percentage of participants with very rapid virological response (VRVR) (defined as VR/UVR by study week 2), rapid virological response (RVR) (defined as VR/UVR by study week 4, but no VRVR), complete early virological response (cEVR) (defined as VR/UVR by study week 12, but no VRVR or RVR) and partial early virological response (pEVR) (defined as a 2 log10 drop of HCV RNA by study week 12, but no VRVR, RVR or cEVR) were reported.
  • Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR) [ Time Frame: Up to 98 weeks ]
    Extended (rapid) virological response (eRVR) defined as UVR at weeks 4 and 12 for telaprevir, and as UVR at weeks 8 and 24 for boceprevir.
  • Duration of Overall Treatment [ Time Frame: Up to 118 weeks ]
    Duration of overall treatment was defined as the time between first and last administration of any study drug, in weeks.
  • Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC) [ Time Frame: Up to 118 weeks ]
  • Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV) [ Time Frame: Up to 72 weeks of treatment ]
    Participants who prolonged the treatment period from 72 weeks were not reported.
  • Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA) [ Time Frame: Up to 72 weeks of treatment ]
    Participants who prolonged the treatment period from 72 weeks were not reported. Participants who discontinued their treatment as planned were included. Here, number of participant analyzed is the total number of participants who received direct-acting anti-viral (DAA).
  • Percentage of Participants With Concomitant Medical Condition at Baseline [ Time Frame: Baseline ]
  • Percentage of Participants With Adverse Events (AE) [ Time Frame: Up to 118 weeks ]
    An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
  • Virological response (in correlation with on-treatment factors) [ Time Frame: approximately 4 years ]
  • Duration of treatment [ Time Frame: approximately 4 years ]
  • Percentage of patients treated according to label / Summary of Product Characteristics (SPC) [ Time Frame: approximately 4 years ]
  • Treatment discontinuation (time, reasons) [ Time Frame: approximately 4 years ]
  • Sustained virological response in correlation with dose reductions/treatment interruptions [ Time Frame: approximately 4 years ]
  • Treatment (drugs, regimen) in relation to medical history/concomitant medical conditions [ Time Frame: approximately 4 years ]
  • Incidence of viral rebound on DAA based triple therapy [ Time Frame: approximately 4 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ]
Not Provided
Not Provided
 
An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C
Non-Interventional Cohort Study on the Utilization and Impact of Dual and Triple Therapies Based on Pegylated Interferon for the Treatment of Chronic Hepatitis C
This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of pegylated interferon alfa (peginterferon alfa) (e.g. Pegasys) plus ribavirin and treatment regimens containing direct-acting antivirals in participants with chronic hepatitis C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be collected from participants receiving treatment according to current Summary of Product Characteristics (SPC) and local labeling for the duration of their treatment and a 24-week follow-up.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Chronic hepatitis C (CHC) participants (naïve or treatment experienced, including HIV HCV co-infected) receiving combination therapy with pegylated interferons plus ribavirin or treatment regimens containing direct-acting antivirals.
Hepatitis C, Chronic
  • Drug: Peg-IFN Alfa-2a
    Peg-IFN Alfa-2a according to standard of care and in line with local labeling.
  • Drug: Peg-IFN Alfa-2b
    Peg-IFN Alfa-2b according to standard of care and in line with local labeling.
  • Drug: Ribavirin
    Ribavirin according to standard of care and in line with local labeling.
  • Drug: Boceprevir
    Boceprevir according to standard of care and in line with local labeling.
  • Drug: Telaprevir
    Telaprevir according to standard of care and in line with local labeling.
  • Dual Therapy: Peg-IFN Alfa-2a + Ribavirin
    Participants with chronic hepatitis C (CHC) receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed up for the duration of their treatment and for up to 24 weeks after therapy.
    Interventions:
    • Drug: Peg-IFN Alfa-2a
    • Drug: Ribavirin
  • Dual Therapy: Peg-IFN Alfa-2b + Ribavirin
    Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
    Interventions:
    • Drug: Peg-IFN Alfa-2b
    • Drug: Ribavirin
  • Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin
    Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
    Interventions:
    • Drug: Peg-IFN Alfa-2a
    • Drug: Ribavirin
    • Drug: Boceprevir
  • Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin
    Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
    Interventions:
    • Drug: Peg-IFN Alfa-2b
    • Drug: Ribavirin
    • Drug: Boceprevir
  • Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin
    Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
    Interventions:
    • Drug: Peg-IFN Alfa-2a
    • Drug: Ribavirin
    • Drug: Telaprevir
  • Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin
    Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
    Interventions:
    • Drug: Peg-IFN Alfa-2b
    • Drug: Ribavirin
    • Drug: Telaprevir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4442
July 2015
July 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult (according to local legislation) participants
  • Chronic hepatitis C (HCV)
  • Naive or treatment experienced, HIV-HCV co-infected or HCV mono-infected
  • Receiving treatment for HCV with pegylated interferons plus ribavirin or regimens containing direct-acting antivirals (DAA) according to standard of care and in line with current SPC/local labeling

Exclusion Criteria:

  • Contraindications according to SPC/local labeling
  • Treatment started >4 weeks before entering study
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Egypt,   Estonia,   France,   Germany,   Greece,   Hungary,   Ireland,   Italy,   Kuwait,   Lebanon,   Macedonia, The Former Yugoslav Republic of,   Morocco,   Oman,   Pakistan,   Portugal,   Qatar,   Romania,   Saudi Arabia,   Serbia,   Sweden,   Switzerland,   Syrian Arab Republic,   Taiwan,   Turkey,   United Arab Emirates,   United Kingdom
India,   United States
 
NCT01447446
MV25599
Not Provided
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP