Chronic Hepatitis CPhase 4OPTIMALNCT01405027
Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy
A Phase 4 study testing Educational Intervention and Patient education and management skills training in people with Chronic Hepatitis C and Genotype 1, run by Chronic Liver Disease Foundation at 43 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C, Genotype 1
- What is being tested?
- Educational Intervention and Patient education and management skills training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 43 sitesUnited States
- Study dates
- Dec 2011to Jul 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
California Liver Institute
Beverly Hills, California, 90210
Digestive Disease Consultants
Bourbonnais, Illinois, 60914
Samuel Burstein, MD
Calabasas, California, 91302
Bay Area Gastroenterology
Clearwater, Florida, 33756
Associates in Gastroenterology
Colorado Springs, Colorado, 80909
Henry Ford Health System
Detroit, Michigan, 48202
South Denver Gastroenterology
Englewood, Colorado, 80113
Metropolitan Research
Fairfax, Virginia, 22031
South Oakland Gastroenterology
Farmington Hills, Michigan, 48336
North Shore Gastroenterology Associates
Great Neck, New York, 11203
Digestive Medicine Associates
Hialeah, Florida, 33016
Indiana University
Indianapolis, Indiana, 46202
University of Iowa Health Center
Iowa City, Iowa, 53342
Saint Luke's Health Center
Kansas City, Missouri, 64111
Saint Luke's Hospital
Kansas City, Missouri, 64111
Michael Fedotin, MD
Kansas City, Missouri, 64132
James Johnson, MD
Lakeland, Florida, 33805
Florida Center for Gastroenterology
Largo, Florida, 33777
Gastroenterology Consultants
Live Oak, Texas, 78233
Medical Associates of Central Virginia
Lynchburg, Virginia, 24501
Union Lake Clinic
Madison Heights, Michigan, 48071
North Shore University Hospital
Manhasset, New York, 11030
Metropolitan Gastroenterology Associates
Metairie, Louisiana, 70006
Consultants in Gastroenerology
Munster, Indiana, 46321
Consultants in Gastroenterology
Munster, Indiana, 46321
Columbia University Medical Center
New York, New York, 10032
Marwan Iskandarani, MD
North Miami Beach, Florida, 33169
Temple Physicians
Philadelphia, Pennsylvania, 19134
Temple University
Philadelphia, Pennsylvania, 19140
Advanced Gastro and Liver Disease
Pinellas Park, Florida, 33781
Dr. Glenn S. Freed, DO
Pottsville, Pennsylvania, 17901
GI Medicine Associates
Saint Clair Shores, Michigan, 48081
Brooke Army Medical Center
San Antonio, Texas, 78234
William Katkov, MD
Santa Monica, California, 90404
Lee S. Mitchel, MD
Sarasota, Florida, 34239
St. Louis University Liver Center
St Louis, Missouri, 63110
Mercy Digestive Disease
St Louis, Missouri, 63141
Tampa General Hospital
Tampa, Florida, 33606
Wabash Valley Infectious Disease
Terre Haute, Indiana, 47802
NY Associates in Gastroenterology
The Bronx, New York, 10461
Sutha Sachar, MD
Torrance, California, 90277
Harbor UCLA Medical Professional Group
Torrance, California, 90509
Main Line Gastroenterology
Wynnewood, Pennsylvania, 19096
About this study
Official 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.
Read the 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.
- Conditions
- Chronic Hepatitis C, Genotype 1
- Being tested
- Educational Intervention, Patient education and management skills training
- Keywords
- HCV, Genotype1, Naive, Partial responder, Relapser
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionProcedure or surgery
Also called Peg-Intron, Pegasys, Victrelis, Pegylated interferon alfa 2B
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.
Patient education and management skills trainingOther
Also called Peg-Intron, Pegasys, Victrelis, Pegylated interferon alfa 2B
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patient education and management skills training |
| 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. Receives: Procedure: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: End of treatment up to treatment week 48
Secondary outcomes (4)
Drug Exposure
Total number of patients receiving treatment over specified time intervals.
Measured: 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.
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.
Measured: 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.
Measured: 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
Measured: Throughout entire study, at end of treatment and follow up week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chronic Liver Disease Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- SCRI Development Innovations, LLC, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Fred Poordad, MD, Principal investigator, Chronic Liver Disease Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405027
- Sponsor's protocol ID
- CLDF-MER-001-00
- Other IDs
- 20111013
- Acronym
- OPTIMAL
- Status last verified
- Dec 2014
- First submitted
- 25 Jul 2011
- Last updated
- 6 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26327916
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boceprevir in Community Practice: Assessing Safety, Efficacy, Compliance and Quality of Life, Impact of an Education Program
- ClinicalTrials.gov ID
- NCT01405027
- Acronym / sponsor ID
- OPTIMAL / CLDF-MER-001-00
- Conditions
- Chronic Hepatitis C, Genotype 1
- Keywords
- HCV, Genotype1, Naive, Partial responder, Relapser
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Chronic Liver Disease FoundationUniversity, hospital or other
- Collaborators
- SCRI Development Innovations, LLC, Merck Sharp & Dohme LLC
- Study start
- Dec 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Posted 6 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - HCEE | Other | Other: Patient education and management skills trainingGroup 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. |
| Group B - Community Sites | Other | Procedure: Educational InterventionGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Peg-Intron, Pegasys, Victrelis, Pegylated interferon alfa 2BReceive 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. | Procedure or surgery | Group B - Community Sites |
| Patient education and management skills trainingAlso: Peg-Intron, Pegasys, Victrelis, Pegylated interferon alfa 2BCommunity 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 | Group A - HCEE |
Primary outcome
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).
4 secondary outcomes
Drug Exposure
Time frame: 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.
Time frame: 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)
Time frame: Baseline, end of treatment, follow-up week 24
Number of Participants With Adverse Events
Time frame: Throughout entire study, at end of treatment and follow up week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26327916Poordad 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.
- Click here for more information about the Chronic Liver Disease Foundation and Hepatology Centers of Educational ExpertiseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred Poordad, MD principal investigator
Chronic Liver Disease Foundation
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Educational Intervention and Patient education and management skills training in people with Chronic Hepatitis C and Genotype 1, run by Chronic Liver Disease Foundation at 43 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Duration Compliance Rate (time frame: End of treatment up to treatment week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01405027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015.