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.
Brief Title
Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Chronic Hepatitis C
Genotype 1
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
HCV
Genotype1
Naive
Partial responder
Relapser
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01405027
Org Class
Other
Org Full Name
Chronic Liver Disease Foundation
Org Study Id
CLDF-MER-001-00
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Boceprevir in Community Practice: Assessing Safety, Efficacy, Compliance and Quality of Life, Impact of an Education Program
Primary Outcomes
Outcome Description
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).
Outcome Measure
Treatment Duration Compliance Rate
Outcome Time Frame
End of treatment up to treatment week 48
Secondary Ids
Secondary Id
20111013
Secondary Outcomes
Outcome Description
Total number of patients receiving treatment over specified time intervals.
Outcome Time Frame
End of treatment up to treatment week 48
Outcome Measure
Drug Exposure
Outcome Description
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.
Outcome Time Frame
Follow-up week 24
Outcome 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.
Outcome Description
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.
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.
Outcome Time Frame
Baseline, end of treatment, follow-up week 24
Outcome Measure
Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)
Outcome Description
Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs
Outcome Time Frame
Throughout entire study, at end of treatment and follow up week 24
Outcome Measure
Number of Participants With Adverse Events
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Paul Gaglio
Investigator Email
PGAGLIO@montefiore.org
Investigator Phone
Categories Mesh Debug
Hepatitis --- HEPATITIS C, CHRONIC
Hepatitis --- HEPATITIS C
Blood Disorders --- BLOOD-BORNE INFECTIONS
HIV/AIDS --- BLOOD-BORNE INFECTIONS
Infectious Disease --- BLOOD-BORNE INFECTIONS
Hepatitis --- COMMUNICABLE DISEASES
HIV/AIDS --- COMMUNICABLE DISEASES
Infectious Disease --- COMMUNICABLE DISEASES
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
Hepatitis --- HEPATITIS, VIRAL, HUMAN
COVID-19 --- VIRUS DISEASES
Hepatitis --- VIRUS DISEASES
Infectious Disease --- VIRUS DISEASES
COVID-19 --- RNA VIRUS INFECTIONS
Infectious Disease --- RNA VIRUS INFECTIONS
Hepatitis --- HEPATITIS, CHRONIC
Hepatitis --- HEPATITIS
Digestive System --- LIVER DISEASES
Liver --- LIVER DISEASES
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
MeSH Terms
HEPATITIS C, CHRONIC
HEPATITIS C
BLOOD-BORNE INFECTIONS
COMMUNICABLE DISEASES
INFECTIONS
HEPATITIS, VIRAL, HUMAN
VIRUS DISEASES
FLAVIVIRIDAE INFECTIONS
RNA VIRUS INFECTIONS
HEPATITIS, CHRONIC
HEPATITIS
LIVER DISEASES
DIGESTIVE SYSTEM DISEASES
CHRONIC DISEASE
DISEASE ATTRIBUTES
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
EARLY INTERVENTION, EDUCATIONAL
PEGINTERFERON ALFA-2B
PEGINTERFERON ALFA-2A
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
RIBAVIRIN
PATIENT EDUCATION AS TOPIC
CHILD HEALTH SERVICES
COMMUNITY HEALTH SERVICES
HEALTH SERVICES
HEALTH CARE FACILITIES WORKFORCE AND SERVICES
PREVENTIVE HEALTH SERVICES
RIBONUCLEOSIDES
NUCLEOSIDES
NUCLEIC ACIDS, NUCLEOTIDES, AND NUCLEOSIDES
HEALTH EDUCATION