Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

A Study to Examine Patient Characteristics, Health Care Management and Health Outcomes of Hepatitis C Virus (HCV) Patients Treated With Simeprevir

19. februar 2016 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

315

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Phoenix, Arizona, Forente stater
    • California
      • Bakersfield, California, Forente stater
      • Beverly Hills, California, Forente stater
      • Los Angeles, California, Forente stater
    • Florida
      • Daytona Beach, Florida, Forente stater
      • Deland, Florida, Forente stater
      • Miami, Florida, Forente stater
      • Tampa, Florida, Forente stater
      • West Palm Beach, Florida, Forente stater
    • Kentucky
      • Crestview Hills, Kentucky, Forente stater
    • Maryland
      • Baltimore, Maryland, Forente stater
    • Massachusetts
      • Springfield, Massachusetts, Forente stater
    • New Jersey
      • Newark, New Jersey, Forente stater
      • Vineland, New Jersey, Forente stater
    • New York
      • Brooklyn, New York, Forente stater
      • Flushing, New York, Forente stater
      • New York, New York, Forente stater
      • Ny, New York, Forente stater
    • North Carolina
      • Durham, North Carolina, Forente stater
      • Fayetteville, North Carolina, Forente stater
      • Rocky Mount, North Carolina, Forente stater
      • Statesville, North Carolina, Forente stater
      • Winston Salem, North Carolina, Forente stater
    • Ohio
      • Cincinnati, Ohio, Forente stater
    • Pennsylvania
      • Doylestown, Pennsylvania, Forente stater
      • Philadelphia, Pennsylvania, Forente stater
    • Tennessee
      • Nashville, Tennessee, Forente stater
    • Texas
      • Austin, Texas, Forente stater
      • Dallas, Texas, Forente stater
      • Fort Worth, Texas, Forente stater
      • Houston, Texas, Forente stater
    • Utah
      • Murray, Utah, Forente stater
    • Virginia
      • Norfolk, Virginia, Forente stater

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Hepatitis C virus (HCV) infected patients receiving simeprevir.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Hepatitis C virus infected patients receiving simeprevir
Legemiddel: No intervention
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Patients who Achieve Sustained Virologic Response(SVR)
Tidsramme: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
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.
12 weeks after the actual end of treatment (an expected average of up to 2 years)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Determination of Prognostic Factors of Virologic Response
Tidsramme: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
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.
12 weeks after the actual end of treatment (an expected average of up to 2 years)
Total duration of therapy
Tidsramme: Up to actual end of treatment (an expected average of up to 2 years)
Actual end of treatment will be determined by health care provider.
Up to actual end of treatment (an expected average of up to 2 years)
Number of Patients who Discontinue Therapy by reason
Tidsramme: Up to actual end of treatment (an expected average of up to 2 years)
Actual end of treatment will be determined by health care provider.
Up to actual end of treatment (an expected average of up to 2 years)
Number of Patients who Achieve Rapid Virologic Response (RVR)
Tidsramme: Week 4
RVR is defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 4.
Week 4
Number of Patients who Achieve Sustained Virologic Response(SVR) Among Participants who Achieve Rapid Virologic Response (RVR)
Tidsramme: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
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.
12 weeks after the actual end of treatment (an expected average of up to 2 years)
Number of Patients who Achieve Sustained Virologic Response(SVR) According to Patient Demographics, Baseline Disease Characteristics, Treatment Paradigm, and Select Practice Setting Features
Tidsramme: 12 weeks after the actual end of treatment (an expected average of up to 2 years)
Actual end of treatment will be determined by health care provider.
12 weeks after the actual end of treatment (an expected average of up to 2 years)
Number of Patients With On-treatment Virologic Failure
Tidsramme: Up to actual end of treatment (an expected average of up to 2 years)
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.
Up to actual end of treatment (an expected average of up to 2 years)
Number of Patients With Viral Relapse
Tidsramme: Up to actual end of treatment (an expected average of up to 2 years)
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.
Up to actual end of treatment (an expected average of up to 2 years)
Number of Patients With Adverse Events by Grade and Causality
Tidsramme: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
Actual end of treatment will be determined by health care provider.
Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
Number of Patients With Changes in Clinical Laboratory Parameters by Grade and Causality
Tidsramme: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
Actual end of treatment will be determined by health care provider.
Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
Number of Patients With Adverse Event Determined to be Related to Simeprevir
Tidsramme: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
Actual end of treatment will be determined by health care provider.
Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
Number of Patients With Serious Adverse Event
Tidsramme: Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
Actual end of treatment will be determined by health care provider.
Up to 24 weeks after the actual end of treatment (an expected average of up to 2 years)
Number of Patients who Develop Mutations at the Time of Virologic Failure
Tidsramme: Up to actual end of treatment (an expected average of up to 2 years)
Actual end of treatment will be determined by health care provider.
Up to actual end of treatment (an expected average of up to 2 years)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Janssen Scientific Affairs, LLC

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2014

Primær fullføring (Faktiske)

1. november 2015

Studiet fullført (Faktiske)

1. januar 2016

Datoer for studieregistrering

Først innsendt

18. februar 2014

Først innsendt som oppfylte QC-kriteriene

1. april 2014

Først lagt ut (Anslag)

4. april 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

22. februar 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. februar 2016

Sist bekreftet

1. februar 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CR101973
  • TMC435HPC4003 (Annen identifikator: Janssen Scientific Affairs, LLC)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere