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Completed

NCT Number: NCT01405027

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

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Genotype 1 Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

California Liver Institute, Beverly Hills, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

educational intervention

Procedure

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.

Other names: Peg-Intron, Pegasys, Victrelis, Pegylated interferon alfa 2B, Pegylated interferon alfa 2A, Boceprevir, Ribavirin

Patient education and management skills training

Other

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.

Other names: Peg-Intron, Pegasys, Victrelis, Pegylated interferon alfa 2B, Pegylated interferon alfa 2A, Boceprevir, Ribavirin

Primary outcomes

  1. Treatment Duration Compliance Rate

    Time frame: 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).

Secondary outcomes

  1. Drug Exposure

    Time frame: End of treatment up to treatment week 48

    Total number of patients receiving treatment over specified time intervals.

  2. Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.

    Time frame: 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.

  3. Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)

    Time frame: 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.

  4. Number of Participants With Adverse Events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Chronic Liver Disease Foundation

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • SCRI Development Innovations, LLC

Registry information

Official study title

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

Acronym: OPTIMAL

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 29, 2011
Registry last updated
Jan 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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