- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02103699
A Study to Examine Patient Characteristics, Health Care Management and Health Outcomes of Hepatitis C Virus (HCV) Patients Treated With Simeprevir
19 februari 2016 uppdaterad 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).
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
315
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Arizona
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Phoenix, Arizona, Förenta staterna
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California
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Bakersfield, California, Förenta staterna
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Beverly Hills, California, Förenta staterna
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Los Angeles, California, Förenta staterna
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Florida
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Daytona Beach, Florida, Förenta staterna
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Deland, Florida, Förenta staterna
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Miami, Florida, Förenta staterna
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Tampa, Florida, Förenta staterna
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West Palm Beach, Florida, Förenta staterna
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Kentucky
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Crestview Hills, Kentucky, Förenta staterna
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Maryland
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Baltimore, Maryland, Förenta staterna
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Massachusetts
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Springfield, Massachusetts, Förenta staterna
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New Jersey
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Newark, New Jersey, Förenta staterna
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Vineland, New Jersey, Förenta staterna
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New York
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Brooklyn, New York, Förenta staterna
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Flushing, New York, Förenta staterna
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New York, New York, Förenta staterna
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Ny, New York, Förenta staterna
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North Carolina
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Durham, North Carolina, Förenta staterna
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Fayetteville, North Carolina, Förenta staterna
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Rocky Mount, North Carolina, Förenta staterna
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Statesville, North Carolina, Förenta staterna
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Winston Salem, North Carolina, Förenta staterna
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Ohio
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Cincinnati, Ohio, Förenta staterna
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Pennsylvania
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Doylestown, Pennsylvania, Förenta staterna
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Philadelphia, Pennsylvania, Förenta staterna
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Tennessee
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Nashville, Tennessee, Förenta staterna
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Texas
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Austin, Texas, Förenta staterna
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Dallas, Texas, Förenta staterna
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Fort Worth, Texas, Förenta staterna
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Houston, Texas, Förenta staterna
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Utah
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Murray, Utah, Förenta staterna
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Virginia
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Norfolk, Virginia, Förenta staterna
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Hepatitis C virus (HCV) infected patients receiving simeprevir.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Number of Patients who Achieve Sustained Virologic Response(SVR)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Determination of Prognostic Factors of Virologic Response
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2014
Primärt slutförande (Faktisk)
1 november 2015
Avslutad studie (Faktisk)
1 januari 2016
Studieregistreringsdatum
Först inskickad
18 februari 2014
Först inskickad som uppfyllde QC-kriterierna
1 april 2014
Första postat (Uppskatta)
4 april 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
22 februari 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 februari 2016
Senast verifierad
1 februari 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CR101973
- TMC435HPC4003 (Annan identifierare: Janssen Scientific Affairs, LLC)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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