Clinical trial NCT01405027: Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy
Official title: Boceprevir in Community Practice: Assessing Safety, Efficacy, Compliance and Quality of Life, Impact of an Education Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis C
Genotype 1
Keywords: HCV
Genotype1
Naive
Partial responder
Relapser
Lead sponsor: Chronic Liver Disease Foundation
Sponsor class: OTHER
Collaborators: name: SCRI Development Innovations, LLC
name: Merck Sharp & Dohme LLC
First posted: 2011-07-29
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment Duration Compliance Rate
timeFrame: End of treatment up to treatment week 48
Secondary outcomes:
measure: Drug Exposure
timeFrame: End of treatment up to treatment week 48
measure: Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.
timeFrame: Follow-up week 24
measure: Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
timeFrame: Baseline, end of treatment, follow-up week 24
measure: Number of Participants With Adverse Events
timeFrame: Throughout entire study, at end of treatment and follow up week 24
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: California Liver Institute
state: California
city: Calabasas
country: United States
facility: Samuel Burstein, MD
state: California
city: Santa Monica
country: United States
facility: William Katkov, MD
state: California
city: Torrance
country: United States
facility: Sutha Sachar, MD
state: California
city: Torrance
country: United States
facility: Harbor UCLA Medical Professional Group
state: California
city: Colorado Springs
country: United States
facility: Associates in Gastroenterology
state: Colorado
city: Englewood
country: United States
facility: South Denver Gastroenterology
state: Colorado
city: Clearwater
country: United States
facility: Bay Area Gastroenterology
state: Florida
city: Hialeah
country: United States
facility: Digestive Medicine Associates
state: Florida
city: Lakeland
country: United States
facility: James Johnson, MD
state: Florida
city: Largo
country: United States
facility: Florida Center for Gastroenterology
state: Florida
city: North Miami Beach
country: United States
facility: Marwan Iskandarani, MD
state: Florida
city: Pinellas Park
country: United States
facility: Advanced Gastro and Liver Disease
state: Florida
city: Sarasota
country: United States
facility: Lee S. Mitchel, MD
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Bourbonnais
country: United States
facility: Digestive Disease Consultants
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Munster
country: United States
facility: Consultants in Gastroenerology
state: Indiana
city: Munster
country: United States
facility: Consultants in Gastroenterology
state: Indiana
city: Terre Haute
country: United States
facility: Wabash Valley Infectious Disease
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Health Center
state: Iowa
city: Metairie
country: United States
facility: Metropolitan Gastroenterology Associates
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Farmington Hills
country: United States
facility: South Oakland Gastroenterology
state: Michigan
city: Madison Heights
country: United States
facility: Union Lake Clinic
state: Michigan
city: St Clair Shores
country: United States
facility: GI Medicine Associates
state: Michigan
city: Kansas City
country: United States
facility: Saint Luke's Health Center
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: Kansas City
country: United States
facility: Michael Fedotin, MD
state: Missouri
city: St. Louis
country: United States
facility: St. Louis University Liver Center
state: Missouri
city: St. Louis
country: United States
facility: Mercy Digestive Disease
state: Missouri
city: Bronx
country: United States
facility: NY Associates in Gastroenterology
state: New York
city: Great Neck
country: United States
facility: North Shore Gastroenterology Associates
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Philadelphia
country: United States
facility: Temple Physicians
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pottsville
country: United States
facility: Dr. Glenn S. Freed, DO
state: Pennsylvania
city: Wynnewood
country: United States
facility: Main Line Gastroenterology
state: Pennsylvania
city: Live Oak
country: United States
facility: Gastroenterology Consultants
state: Texas
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
city: Lynchburg
country: United States
facility: Medical Associates of Central Virginia
state: Virginia
Study officials:
affiliation: Chronic Liver Disease Foundation
name: Fred Poordad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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). Therap Adv Gastroenterol. 2015 Sep;8(5):263-9. doi: 10.1177/1756283X15588876.