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Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy (OPTIMAL)

22 december 2014 uppdaterad av: Chronic Liver Disease Foundation

Boceprevir in Community Practice: Assessing Safety, Efficacy, Compliance and Quality of Life, Impact of an Education Program

The purpose of this study is to evaluate the impact of a physician directed education program on treatment compliance of hepatitis C patients administered triple drug therapy of pegylated interferon, ribavirin and boceprevir.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

The new treatment paradigm for HCV in the era of protease inhibitors will add a level of complexity that was previously not seen with pegylated interferon and ribavirin. In addition to new concepts such as utilization of a lead-in period, compliance with a TID dosing regimen of a third agent, development of resistance, and futility rules and decision points have yet to be assessed in a real life practice setting. The OPTIMAL trial is designed to evaluate the impact of an education program for community sites participating in a CLDF study treating chronic HCV genotype 1 patients. Group A will be comprised of approximately 30 CLDF designated Hepatology Centers of Educational Expertise (HCEE) and Group B will be comprised of approximately 60 community sites. Group A will also deliver the educational program regarding the use of HCV protease inhibitors, and the overall treatment of HCV to approximately two (2) community sites in it's geographic region. Group B will be comprised of community sites that have no previous clinical trial experience with boceprevir or an HCV protease inhibitor. For the purpose of this study, each community site in Group B will be assigned to an HCEE.

Studietyp

Interventionell

Inskrivning (Faktisk)

197

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • Beverly Hills, California, Förenta staterna, 90210
        • California Liver Institute
      • Calabasas, California, Förenta staterna, 91302
        • Samuel Burstein, MD
      • Santa Monica, California, Förenta staterna, 90404
        • William Katkov, MD
      • Torrance, California, Förenta staterna, 90277
        • Sutha Sachar, MD
      • Torrance, California, Förenta staterna, 90509
        • Harbor UCLA Medical Professional Group
    • Colorado
      • Colorado Springs, Colorado, Förenta staterna, 80909
        • Associates in Gastroenterology
      • Englewood, Colorado, Förenta staterna, 80113
        • South Denver Gastroenterology
    • Florida
      • Clearwater, Florida, Förenta staterna, 33756
        • Bay Area Gastroenterology
      • Hialeah, Florida, Förenta staterna, 33016
        • Digestive Medicine Associates
      • Lakeland, Florida, Förenta staterna, 33805
        • James Johnson, MD
      • Largo, Florida, Förenta staterna, 33777
        • Florida Center for Gastroenterology
      • North Miami Beach, Florida, Förenta staterna, 33169
        • Marwan Iskandarani, MD
      • Pinellas Park, Florida, Förenta staterna, 33781
        • Advanced Gastro and Liver Disease
      • Sarasota, Florida, Förenta staterna, 34239
        • Lee S. Mitchel, MD
      • Tampa, Florida, Förenta staterna, 33606
        • Tampa General Hospital
    • Illinois
      • Bourbonnais, Illinois, Förenta staterna, 60914
        • Digestive Disease Consultants
    • Indiana
      • Indianapolis, Indiana, Förenta staterna, 46202
        • Indiana University
      • Munster, Indiana, Förenta staterna, 46321
        • Consultants in Gastroenerology
      • Munster, Indiana, Förenta staterna, 46321
        • Consultants in Gastroenterology
      • Terre Haute, Indiana, Förenta staterna, 47802
        • Wabash Valley Infectious Disease
    • Iowa
      • Iowa City, Iowa, Förenta staterna, 53342
        • University of Iowa Health Center
    • Louisiana
      • Metairie, Louisiana, Förenta staterna, 70006
        • Metropolitan Gastroenterology Associates
    • Michigan
      • Detroit, Michigan, Förenta staterna, 48202
        • Henry Ford Health System
      • Farmington Hills, Michigan, Förenta staterna, 48336
        • South Oakland Gastroenterology
      • Madison Heights, Michigan, Förenta staterna, 48071
        • Union Lake Clinic
      • St Clair Shores, Michigan, Förenta staterna, 48081
        • GI Medicine Associates
    • Missouri
      • Kansas City, Missouri, Förenta staterna, 64111
        • Saint Luke's Hospital
      • Kansas City, Missouri, Förenta staterna, 64111
        • Saint Luke's Health Center
      • Kansas City, Missouri, Förenta staterna, 64132
        • Michael Fedotin, MD
      • St. Louis, Missouri, Förenta staterna, 63110
        • St. Louis University Liver Center
      • St. Louis, Missouri, Förenta staterna, 63141
        • Mercy Digestive Disease
    • New York
      • Bronx, New York, Förenta staterna, 10461
        • NY Associates in Gastroenterology
      • Great Neck, New York, Förenta staterna, 11203
        • North Shore Gastroenterology Associates
      • Manhasset, New York, Förenta staterna, 11030
        • North Shore University Hospital
      • New York, New York, Förenta staterna, 10032
        • Columbia University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19140
        • Temple University
      • Philadelphia, Pennsylvania, Förenta staterna, 19134
        • Temple Physicians
      • Pottsville, Pennsylvania, Förenta staterna, 17901
        • Dr. Glenn S. Freed, DO
      • Wynnewood, Pennsylvania, Förenta staterna, 19096
        • Main Line Gastroenterology
    • Texas
      • Live Oak, Texas, Förenta staterna, 78233
        • Gastroenterology Consultants
      • San Antonio, Texas, Förenta staterna, 78234
        • Brooke Army Medical Center
    • Virginia
      • Fairfax, Virginia, Förenta staterna, 22031
        • Metropolitan Research
      • Lynchburg, Virginia, Förenta staterna, 24501
        • Medical Associates of Central Virginia

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

Beskrivning

Inclusion Criteria:

  • Chronic Hepatitis C (HCV) genotype 1
  • Detectable HCV-RNA within 180 days of screening
  • Age ≥ 18 years
  • Weight > 40 kg
  • Patient and partner(s) must agree to use acceptable methods of contraception
  • Written informed consent

Exclusion Criteria:

  • Known co-infection with HIV or HBV
  • Previous interferon or ribavirin regimen requiring discontinuation for an adverse event considered related to ribavirin and/or interferon
  • Currently taking or planning on taking any prohibited medications
  • Evidence of decompensated liver disease including the presence of clinical ascites, bleeding varices, or hepatic encephalopathy
  • Diabetes and/or hypertension with clinically significant ocular examination findings
  • Pre-existing psychiatric condition(s)
  • History of severe and uncontrolled psychiatric disorders
  • Active alcohol or drug abuse (not including marijuana)
  • Pre-existing medical condition that could interfere with the patient's participation in the study
  • Chronic obstructive pulmonary disease
  • Abnormal lab values

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: Group A - HCEE
Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor. HCEE investigators provided patient education and management skills training during four (4) educational interventions to Community Site investigators.
Övrig: Patient education and management skills training
Community sites received patient education and management skills training by HCEE investigators during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes.
Andra namn:
  • Pegasys
  • Ribavirin
  • Peg-Intron
  • Victrelis
  • Pegylated interferon alfa 2B
  • Pegylated interferon alfa 2A
  • Boceprevir
Övrig: Group B - Community Sites
Group B - community physicians treating HCV but without clinical trial experience with an HCV protease inhibitor received patient education and management skills training from Hepatology Centers of Educational Expertise (HCEEs) during four (4) educational interventions.
Procedur: Educational Intervention
Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes.
Andra namn:
  • Pegasys
  • Ribavirin
  • Peg-Intron
  • Victrelis
  • Pegylated interferon alfa 2B
  • Pegylated interferon alfa 2A
  • Boceprevir

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Treatment Duration Compliance Rate
Tidsram: End of treatment up to treatment week 48
The primary objective will be to define treatment duration compliance rate (calculated as the actual treatment duration in weeks divided by the expected duration in weeks) based on individual patient treatment goals as defined in the OPTIMAL protocol for HCV patients treated with boceprevir, peginterferon and ribavirin for up to 48 weeks. Rates will be reported for HCEEs (Group A) and community sites enrolled in the Program (Group B).
End of treatment up to treatment week 48

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Drug Exposure
Tidsram: End of treatment up to treatment week 48
Total number of patients receiving treatment over specified time intervals.
End of treatment up to treatment week 48
Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.
Tidsram: Follow-up week 24
Rate of SVR was defined as the percentage of participants with HCV-RNA undetectable at follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.
Follow-up week 24
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Tidsram: Baseline, end of treatment, follow-up week 24

Determination of the quality of life for HCV patients treated with boceprevir, peginterferon and ribavirin at community sites and at HCEEs.

Patient scores per subscale (8) were obtained by subtracting the lowest possible raw score from the actual raw score x 100, divided by the lowest possible raw score subtracted from the highest possible raw score. Subscale scores were averaged (with standard deviation) for Group A and Group B. Composite Scores are standardized to the general US population having a mean of 50 and a standard deviation of 10. Higher score = improved quality of life.
Baseline, end of treatment, follow-up week 24
Number of Participants With Adverse Events
Tidsram: Throughout entire study, at end of treatment and follow up week 24
Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs
Throughout entire study, at end of treatment and follow up week 24

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Chronic Liver Disease Foundation

Samarbetspartners

Merck Sharp & Dohme LLC
SCRI Development Innovations, LLC

Utredare

  • Huvudutredare: Fred Poordad, MD, Chronic Liver Disease Foundation

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

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 december 2011

Primärt slutförande (Faktisk)

1 juli 2014

Avslutad studie (Faktisk)

1 juli 2014

Studieregistreringsdatum

Först inskickad

25 juli 2011

Först inskickad som uppfyllde QC-kriterierna

27 juli 2011

Första postat (Uppskatta)

29 juli 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

6 januari 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 december 2014

Senast verifierad

1 december 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CLDF-MER-001-00
  • 20111013 (Annan identifierare: Western Institutional Review Board)

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