A Study to Examine Patient Characteristics, Health Care Management and Health Outcomes of Hepatitis C Virus (HCV) Patients Treated With Simeprevir
19 février 2016 mis à jour par: Janssen Scientific Affairs, LLC
A Prospective Observational Study to Examine Patient Characteristics, Health Care Management, and Effectiveness Among HCV Patients Treated With Simeprevir at Various Practice Settings
The purpose of this study is to evaluate the effectiveness of a simeprevir-containing hepatitis C virus (HCV) treatment regimen as measured by sustained virologic response (SVR).
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This is a multicenter, observational (a study in which the investigators/ physicians observe the patients and measure their outcomes), prospective study (a study in which the patients are identified and then followed forward in time for the outcome of the study) designed to reflect routine clinical practice.
Approximately 300 Hepatitis C virus (HCV) infected patients who are prescribed simeprevir by their health care provider as part of their routine HCV treatment regimen, inclusive of patients who have been treated with a simeprevir-based therapy for less than or equal to (<=) 28 days will be enrolled in this and observed to evaluate the effectiveness of a simeprevir.
Practice setting features will be documented at the initiation of the study by each participating site.
The decision of patients to participate in this study will in no way impact upon the standard of care that they are receiving.
All treatment decisions will be made at the discretion of the health care provider.
Safety assessments will include assessment of adverse events, and clinical laboratory parameters (hematology, clotting tests, human immunodeficiency virus tests, chemistry, and liver function tests).
The maximum study duration for each patient will be approximately 2 years.
Type d'étude
Observationnel
Inscription (Réel)
315
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Arizona
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Phoenix, Arizona, États-Unis
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California
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Bakersfield, California, États-Unis
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Beverly Hills, California, États-Unis
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Los Angeles, California, États-Unis
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Florida
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Daytona Beach, Florida, États-Unis
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Deland, Florida, États-Unis
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Miami, Florida, États-Unis
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Tampa, Florida, États-Unis
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West Palm Beach, Florida, États-Unis
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Kentucky
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Crestview Hills, Kentucky, États-Unis
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Maryland
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Baltimore, Maryland, États-Unis
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Massachusetts
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Springfield, Massachusetts, États-Unis
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New Jersey
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Newark, New Jersey, États-Unis
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Vineland, New Jersey, États-Unis
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New York
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Brooklyn, New York, États-Unis
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Flushing, New York, États-Unis
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New York, New York, États-Unis
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Ny, New York, États-Unis
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North Carolina
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Durham, North Carolina, États-Unis
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Fayetteville, North Carolina, États-Unis
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Rocky Mount, North Carolina, États-Unis
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Statesville, North Carolina, États-Unis
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Winston Salem, North Carolina, États-Unis
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Ohio
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Cincinnati, Ohio, États-Unis
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Pennsylvania
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Doylestown, Pennsylvania, États-Unis
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Philadelphia, Pennsylvania, États-Unis
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Tennessee
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Nashville, Tennessee, États-Unis
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Texas
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Austin, Texas, États-Unis
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Dallas, Texas, États-Unis
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Fort Worth, Texas, États-Unis
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Houston, Texas, États-Unis
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Utah
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Murray, Utah, États-Unis
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Virginia
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Norfolk, Virginia, États-Unis
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Hepatitis C virus (HCV) infected patients receiving simeprevir.
La description
Inclusion Criteria:
- Patients who have genotype 1 chronic hepatitis C infection
- Hepatitis C virus (HCV) ribonucleic acid (RNA) test result above the limit of quantification before initiation of simeprevir-based therapy
- Health care provider decision to treat patient with a simeprevir-based therapy, inclusive of patients who have been treated with a simeprevir-based therapy for less than or equal to (<=) 28 days will be enrolled into the study
- Prior HCV treatment must be completed more than 3 months before initiation of simeprevir-based therapy
- In the opinion of the health care provider, the patient will attend routine standard of care visits, either at enrolled site or by virtual/telemedicine
Exclusion Criteria:
- Non-genotype 1 HCV infected patients
- Absolute contraindication to any component of prescribed HCV treatment per prescribing information
- Patient is currently enrolled in an interventional study
- Past use of an HCV direct-acting antiviral therapy
- Any investigational drug use within 30 days before initiation of simeprevir-based therapy
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Hepatitis C virus infected patients receiving simeprevir
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This is an observational study.
Patients receiving simeprevir (single capsule of 150 mg once daily) as prescribed by the health care provider will be observed.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Patients who Achieve Sustained Virologic Response(SVR)
Délai: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
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SVR is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at least 12 weeks after the actual end of all HCV treatment.
Actual end of treatment will be determined by health care provider.
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12 weeks after the actual end of treatment (an expected average of up to 2 years)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Determination of Prognostic Factors of Virologic Response
Délai: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
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Prognostic factors of virologic response includes patient and disease characteristics, treatment paradigm, Rapid Virologic Response (RVR), and select practice setting features.
Actual end of treatment will be determined by health care provider.
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12 weeks after the actual end of treatment (an expected average of up to 2 years)
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Total duration of therapy
Délai: Up to actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to actual end of treatment (an expected average of up to 2 years)
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Number of Patients who Discontinue Therapy by reason
Délai: Up to actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to actual end of treatment (an expected average of up to 2 years)
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Number of Patients who Achieve Rapid Virologic Response (RVR)
Délai: Week 4
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RVR is defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.
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Week 4
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Number of Patients who Achieve Sustained Virologic Response(SVR) Among Participants who Achieve Rapid Virologic Response (RVR)
Délai: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
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SVR is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at least 12 weeks after the actual end of all HCV treatment.
RVR is defined as undetectable HCV RNA at Week 4. Actual end of treatment will be determined by health care provider.
Actual end of treatment will be determined by health care provider.
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12 weeks after the actual end of treatment (an expected average of up to 2 years)
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Number of Patients who Achieve Sustained Virologic Response(SVR) According to Patient Demographics, Baseline Disease Characteristics, Treatment Paradigm, and Select Practice Setting Features
Délai: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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12 weeks after the actual end of treatment (an expected average of up to 2 years)
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Number of Patients With On-treatment Virologic Failure
Délai: Up to actual end of treatment (an expected average of up to 2 years)
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On-treatment virologic failure is defined as a confirmed increase of >1 log10 IU/mL in hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached, or a confirmed HCV RNA level of >100 IU/mL in patients whose HCV RNA had previously been <25 IU/mL.
Actual end of treatment will be determined by health care provider.
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Up to actual end of treatment (an expected average of up to 2 years)
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Number of Patients With Viral Relapse
Délai: Up to actual end of treatment (an expected average of up to 2 years)
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Viral Relapse is defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) after concluding treatment with undetectable HCV RNA.
Actual end of treatment will be determined by health care provider.
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Up to actual end of treatment (an expected average of up to 2 years)
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Number of Patients With Adverse Events by Grade and Causality
Délai: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Number of Patients With Changes in Clinical Laboratory Parameters by Grade and Causality
Délai: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Number of Patients With Adverse Event Determined to be Related to Simeprevir
Délai: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Number of Patients With Serious Adverse Event
Délai: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
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Number of Patients who Develop Mutations at the Time of Virologic Failure
Délai: Up to actual end of treatment (an expected average of up to 2 years)
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Actual end of treatment will be determined by health care provider.
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Up to actual end of treatment (an expected average of up to 2 years)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 février 2014
Achèvement primaire (Réel)
1 novembre 2015
Achèvement de l'étude (Réel)
1 janvier 2016
Dates d'inscription aux études
Première soumission
18 février 2014
Première soumission répondant aux critères de contrôle qualité
1 avril 2014
Première publication (Estimation)
4 avril 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
22 février 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 février 2016
Dernière vérification
1 février 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CR101973
- TMC435HPC4003 (Autre identifiant: Janssen Scientific Affairs, LLC)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .