Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

19 februari 2016 bijgewerkt door: 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).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Werkelijk)

315

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Hepatitis C virus (HCV) infected patients receiving simeprevir.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Hepatitis C virus infected patients receiving simeprevir
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Patients who Achieve Sustained Virologic Response(SVR)
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Determination of Prognostic Factors of Virologic Response
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Janssen Scientific Affairs, LLC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2014

Primaire voltooiing (Werkelijk)

1 november 2015

Studie voltooiing (Werkelijk)

1 januari 2016

Studieregistratiedata

Eerst ingediend

18 februari 2014

Eerst ingediend dat voldeed aan de QC-criteria

1 april 2014

Eerst geplaatst (Schatting)

4 april 2014

Updates van studierecords

Laatste update geplaatst (Schatting)

22 februari 2016

Laatste update ingediend die voldeed aan QC-criteria

19 februari 2016

Laatst geverifieerd

1 februari 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CR101973
  • TMC435HPC4003 (Andere identificatie: Janssen Scientific Affairs, LLC)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren