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

22 december 2014 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

197

Fase

  • Fase 4

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

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

Beschrijving

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

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

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: 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.
Ander: 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.
Andere namen:
  • Pegasys
  • Ribavirine
  • Peg-Intron
  • Victrelis
  • Pegylated interferon alfa 2B
  • Pegylated interferon alfa 2A
  • Boceprevir
Ander: 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.
Procedure: 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.
Andere namen:
  • Pegasys
  • Ribavirine
  • Peg-Intron
  • Victrelis
  • Pegylated interferon alfa 2B
  • Pegylated interferon alfa 2A
  • Boceprevir

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Treatment Duration Compliance Rate
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Drug Exposure
Tijdsspanne: 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.
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

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

Sponsor

Chronic Liver Disease Foundation

Medewerkers

Merck Sharp & Dohme LLC
SCRI Development Innovations, LLC

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

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 december 2011

Primaire voltooiing (Werkelijk)

1 juli 2014

Studie voltooiing (Werkelijk)

1 juli 2014

Studieregistratiedata

Eerst ingediend

25 juli 2011

Eerst ingediend dat voldeed aan de QC-criteria

27 juli 2011

Eerst geplaatst (Schatting)

29 juli 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

6 januari 2015

Laatste update ingediend die voldeed aan QC-criteria

22 december 2014

Laatst geverifieerd

1 december 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CLDF-MER-001-00
  • 20111013 (Andere identificatie: Western Institutional Review Board)

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 .

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