Chronic Hepatitis C Clinical Trial
— OPTIMALOfficial title:
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.
Status | Completed |
Enrollment | 197 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | California Liver Institute | Beverly Hills | California |
United States | Digestive Disease Consultants | Bourbonnais | Illinois |
United States | NY Associates in Gastroenterology | Bronx | New York |
United States | Samuel Burstein, MD | Calabasas | California |
United States | Bay Area Gastroenterology | Clearwater | Florida |
United States | Associates in Gastroenterology | Colorado Springs | Colorado |
United States | Henry Ford Health System | Detroit | Michigan |
United States | South Denver Gastroenterology | Englewood | Colorado |
United States | Metropolitan Research | Fairfax | Virginia |
United States | South Oakland Gastroenterology | Farmington Hills | Michigan |
United States | North Shore Gastroenterology Associates | Great Neck | New York |
United States | Digestive Medicine Associates | Hialeah | Florida |
United States | Indiana University | Indianapolis | Indiana |
United States | University of Iowa Health Center | Iowa City | Iowa |
United States | Michael Fedotin, MD | Kansas City | Missouri |
United States | Saint Luke's Health Center | Kansas City | Missouri |
United States | Saint Luke's Hospital | Kansas City | Missouri |
United States | James Johnson, MD | Lakeland | Florida |
United States | Florida Center for Gastroenterology | Largo | Florida |
United States | Gastroenterology Consultants | Live Oak | Texas |
United States | Medical Associates of Central Virginia | Lynchburg | Virginia |
United States | Union Lake Clinic | Madison Heights | Michigan |
United States | North Shore University Hospital | Manhasset | New York |
United States | Metropolitan Gastroenterology Associates | Metairie | Louisiana |
United States | Consultants in Gastroenerology | Munster | Indiana |
United States | Consultants in Gastroenterology | Munster | Indiana |
United States | Columbia University Medical Center | New York | New York |
United States | Marwan Iskandarani, MD | North Miami Beach | Florida |
United States | Temple Physicians | Philadelphia | Pennsylvania |
United States | Temple University | Philadelphia | Pennsylvania |
United States | Advanced Gastro and Liver Disease | Pinellas Park | Florida |
United States | Dr. Glenn S. Freed, DO | Pottsville | Pennsylvania |
United States | Brooke Army Medical Center | San Antonio | Texas |
United States | William Katkov, MD | Santa Monica | California |
United States | Lee S. Mitchel, MD | Sarasota | Florida |
United States | GI Medicine Associates | St Clair Shores | Michigan |
United States | Mercy Digestive Disease | St. Louis | Missouri |
United States | St. Louis University Liver Center | St. Louis | Missouri |
United States | Tampa General Hospital | Tampa | Florida |
United States | Wabash Valley Infectious Disease | Terre Haute | Indiana |
United States | Harbor UCLA Medical Professional Group | Torrance | California |
United States | Sutha Sachar, MD | Torrance | California |
United States | Main Line Gastroenterology | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Chronic Liver Disease Foundation | Merck Sharp & Dohme Corp., SCRI Development Innovations, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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). | End of treatment up to treatment week 48 | No |
Secondary | Drug Exposure | Total number of patients receiving treatment over specified time intervals. | End of treatment up to treatment week 48 | No |
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 week 24 | No |
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. |
Baseline, end of treatment, follow-up week 24 | No |
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 | Throughout entire study, at end of treatment and follow up week 24 | Yes |
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