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| ID | Type | Description | Link |
|---|---|---|---|
| 20111013 | Other Identifier | Western Institutional Review Board |
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| Name | Class |
|---|---|
| SCRI Development Innovations, LLC | OTHER |
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - HCEE | Other | 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. |
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| Group B - Community Sites | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Duration Compliance Rate | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Exposure | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fred Poordad, MD | Chronic Liver Disease Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Liver Institute | Beverly Hills | California | 90210 | United States | ||
| Samuel Burstein, MD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26327916 | Derived | Poordad F, Rustgi V, Brown RS Jr, Patel V, Kugelmas M, Regenstein F, Balart L, LaBrecque D, Brown K, Avila M, Biederman M, Freed G, Smith R, Bernstein M, Arnold H, Cahan J, Fink S, Katkov W, Massoumi H, Harrison S. The impact of an educational program on HCV patient outcomes using boceprevir in community practices (OPTIMAL trial). Ther Adv Gastroenterol. 2015 Sep;8(5):263-9. doi: 10.1177/1756283X15588876. |
| Label | URL |
|---|---|
| Click here for more information about the Chronic Liver Disease Foundation and Hepatology Centers of Educational Expertise | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. No Intervention: Deliver patient education and management skills training to community sites 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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. |
|
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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) | 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 | 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 |
| Calabasas |
| California |
| 91302 |
| United States |
| William Katkov, MD | Santa Monica | California | 90404 | United States |
| Sutha Sachar, MD | Torrance | California | 90277 | United States |
| Harbor UCLA Medical Professional Group | Torrance | California | 90509 | United States |
| Associates in Gastroenterology | Colorado Springs | Colorado | 80909 | United States |
| South Denver Gastroenterology | Englewood | Colorado | 80113 | United States |
| Bay Area Gastroenterology | Clearwater | Florida | 33756 | United States |
| Digestive Medicine Associates | Hialeah | Florida | 33016 | United States |
| James Johnson, MD | Lakeland | Florida | 33805 | United States |
| Florida Center for Gastroenterology | Largo | Florida | 33777 | United States |
| Marwan Iskandarani, MD | North Miami Beach | Florida | 33169 | United States |
| Advanced Gastro and Liver Disease | Pinellas Park | Florida | 33781 | United States |
| Lee S. Mitchel, MD | Sarasota | Florida | 34239 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Digestive Disease Consultants | Bourbonnais | Illinois | 60914 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Consultants in Gastroenerology | Munster | Indiana | 46321 | United States |
| Consultants in Gastroenterology | Munster | Indiana | 46321 | United States |
| Wabash Valley Infectious Disease | Terre Haute | Indiana | 47802 | United States |
| University of Iowa Health Center | Iowa City | Iowa | 53342 | United States |
| Metropolitan Gastroenterology Associates | Metairie | Louisiana | 70006 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| South Oakland Gastroenterology | Farmington Hills | Michigan | 48336 | United States |
| Union Lake Clinic | Madison Heights | Michigan | 48071 | United States |
| GI Medicine Associates | Saint Clair Shores | Michigan | 48081 | United States |
| Saint Luke's Health Center | Kansas City | Missouri | 64111 | United States |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Michael Fedotin, MD | Kansas City | Missouri | 64132 | United States |
| St. Louis University Liver Center | St Louis | Missouri | 63110 | United States |
| Mercy Digestive Disease | St Louis | Missouri | 63141 | United States |
| North Shore Gastroenterology Associates | Great Neck | New York | 11203 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| NY Associates in Gastroenterology | The Bronx | New York | 10461 | United States |
| Temple Physicians | Philadelphia | Pennsylvania | 19134 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| Dr. Glenn S. Freed, DO | Pottsville | Pennsylvania | 17901 | United States |
| Main Line Gastroenterology | Wynnewood | Pennsylvania | 19096 | United States |
| Gastroenterology Consultants | Live Oak | Texas | 78233 | United States |
| Brooke Army Medical Center | San Antonio | Texas | 78234 | United States |
| Metropolitan Research | Fairfax | Virginia | 22031 | United States |
| Medical Associates of Central Virginia | Lynchburg | Virginia | 24501 | United States |
| FG001 | Group B - Community Sites | Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. No Intervention: Deliver patient education and management skills training to community sites 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. |
| BG001 | Group B - Community Sites | Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Patient Status | Number | participants |
| ||||||||||||||||
| Hepatitis C Virus Genotype | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Duration Compliance Rate | 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). | Population analyzed represents patients who had a PCR at treatment weeks where expected duration of treatment could have been determined. Subjects who discontinued the study due to Treatment Futility were considered to have 100% treatment duration compliance. | Posted | Mean | 95% Confidence Interval | Percentage of compliance | End of treatment up to treatment week 48 |
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| Secondary | Drug Exposure | Total number of patients receiving treatment over specified time intervals. | Posted | Number | participants | End of treatment up to treatment week 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs. | 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 SVR includes data collected 10 weeks or greater from last treatment. | Posted | Number | percentage of participants | Follow-up week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions) | 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. | The Quality of Life scores are derived from the responses from subjects who completed questionnaires at protocol-scheduled timepoints. | Posted | Mean | Standard Deviation | score | Baseline, end of treatment, follow-up week 24 |
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| Secondary | Number of Participants With Adverse Events | Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs | Posted | Number | participants | Throughout entire study, at end of treatment and follow up week 24 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. No Intervention: Deliver patient education and management skills training to community sites 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. | 6 | 84 | 77 | 84 | ||
| EG001 | Group B - Community Sites | Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor 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. | 8 | 113 | 92 | 113 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pancytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| Stroke | Nervous system disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
| ||
| Irritability | General disorders | Systematic Assessment |
| ||
| Influenza like Illness | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Malaise | General disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Weight decreased | Investigations | Systematic Assessment |
| ||
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
Smaller sample size than expected due to changing treatment landscape for HCV during course of study.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fred Poordad | Chronic Liver Disease Foundation | 732-381-8887 | poordad@txliver.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| C417083 | peginterferon alfa-2b |
| C100416 | peginterferon alfa-2a |
| C512204 | N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide |
| D012254 | Ribavirin |
| D010353 | Patient Education as Topic |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D006266 | Health Education |
Not provided
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| Male |
|
| Black/African American |
|
| Asian |
|
| Latino |
|
| Other |
|
| Previous Partial Responder |
|
| Relapsed |
|
| Compensated Cirrhotic |
|
| Historic Null Responder |
|
| 1b |
|
| Missing |
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
| Group B - Community Sites |
Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor 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. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|