Hepatitis C, ChronicPROP-UPNCT02601820
The Patient-Reported Outcomes Project of HCV-TARGET
An observational study of Hepatitis C, Chronic and Liver Diseases, run by University of North Carolina, Chapel Hill at 11 sites in United States.
Trial summary
The PROP UP research study is funded by The Patient Centered Outcomes Research Institute (PCORI). PROP UP is a multi-centered prospective observational study that will evaluate all-oral treatment regimens for chronic hepatitis C viral (HCV) infection regarding several patient-reported outcomes (PROs) such as… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hepatitis C, Chronic, Liver Diseases
- How many people
- 1,601 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 2015to Jul 2018
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients being evaluated for Hep C treatment in 9 large academic liver centers and two private gastroenterology practices in the US.
Who may be able to join
- Diagnosed with HCV genotype 1-6
- English-speaking
- Age 21 or older
- Medically cleared and being prescribed one of the following DAA regimens:
- sofosbuvir/ledipasvir (SOF/LED) with or without ribavirin
- ombitasvir/paritaprevir/ritonavir with dasabuvir (PRoD), with or without ribavirin
Show all 9Show fewer
- elbasvir/grazoprevir (ELB/GRZ) with or without ribavirin
- daclatasvir/sofosbuvir, with or without ribavirin (DAC/SOF)
- sofosbuvir/velpatasvir (SOF/VEL)
Who cannot join
- Inability to provide written informed consent
- Currently participating in a pharmaceutical-sponsored drug trial of hepatitis C treatment
- Major cognitive or mental impairment
- Unable to read or speak English
- Unwilling or unable to complete survey questionnaires
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Michigan
Ann Arbor, Michigan, 48109
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Rush University
Chicago, Illinois, 60612
University of California at Davis
Davis, California, 95616
University of Florida
Gainesville, Florida, 32611
Yale University
New Haven, Connecticut, 06520
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Virginia Commonwealth University
Richmond, Virginia, 23298
St Louis University
St Louis, Missouri, 63104
Wilmington Gastroenterology Associates
Wilmington, North Carolina, 28403
About this study
Official title: The Patient-Reported Outcomes Project of HCV-TARGET (PROP UP)
The PROP UP research study is funded by The Patient Centered Outcomes Research Institute (PCORI). PROP UP is a multi-centered prospective observational study that will evaluate all-oral treatment regimens for chronic hepatitis C viral (HCV) infection regarding several patient-reported outcomes (PROs) such as HCV-associated symptoms, treatment side effects, medication adherence, out of pocket costs, comorbid conditions, and long-term benefits of cure and harms of treatment to compare PROs of different treatment regimens, treatment durations, and patient subgroups. Participants will be recruited from 9 U.S. liver centers. Approximately 1920 patients with HCV infection who are prescribed a regimen containing Sofosbuvir/Ledipasvir(SOF/LED), SOF/Velpatasvir(SOF/VEL), Grazoprevir/Elbasvir(GRZ/ELB), OBV/PTV/r + DSV (PRoD), or daclatasvir/SOF (DAC/SOF) will be recruited and approximately 1600 patients who are approved and begin HCV treatment will be enrolled in the longitudinal study. PRO surveys will be evaluated before, during and after HCV treatment.
PROP UP is a collaborative effort between behavioral and biomedical researchers, a patient engagement group and a patient advocacy organization.
Read the detailed description
Newer, more effective all-oral regimens for hepatitis C viral (HCV) infection are available. However the available data from industry-sponsored trials do not provide all the information that patients need, nor do these data represent the broad spectrum of patients treated in real-world practice. Trials also exclude disadvantaged subgroups, focus on short-term efficacy and clinician-rated adverse events, rarely obtain the patient's perspective, and do not investigate longer-term harms of treatment or benefits of viral cure. Given these informational gaps, patient-centered outcomes research on treatment harms and benefits that matter most to patients, is needed.
PROP UP is funded by The Patient Centered Outcomes Research Institute (PCORI). PROP UP is a multi-centered prospective observational study that will evaluate newly approved direct acting antiviral (DAA) treatment regimens for HCV regarding several patient-reported outcomes (PROs) such as HCV-associated symptoms, treatment side effects, medication adherence, out of pocket costs, comorbid conditions, and long-term benefits of cure and harms of treatment to compare PROs of different treatment regimens, treatment durations, and patient subgroups.
PROP UP is a collaborative effort between researchers, a patient engagement group, and a patient advocacy organization. Eleven U.S. liver centers will collaborate on PROP UP. Approximately 1920 patients with HCV infection who are prescribed a DAA regimen for chronic HCV will be consented and will complete baseline PRO surveys. Approximately 1600 patients who are approved and begin HCV treatment will be enrolled in the longitudinal study. Participants will complete several PRO surveys at 5 assessment periods during the study: baseline, treatment week 4, end of treatment, 3 months post-treatment, and 12 months post-treatment. PRO survey data will be collected via 3 options: patient home-based computers, tablet, smartphone; phone-administered surveys with a centralized call enter; or at regular clinic visits.
Analysis of PROs collected longitudinally before, during and after treatment for HCV will allow the investigators to answer a variety of questions important to patients and clinicians. Specifically, the investigators will evaluate: (a) prevalence of pre-existing baseline symptoms associated with HCV; (b) the development of new onset treatment side effects and exacerbation of pre-existing symptoms during HCV treatment; (c) medication adherence and out of pocket costs associated with treatment; (d) changes in HCV-associated symptoms and functional status in patients who are cured; (e) long-term patient-reported harms associated with treatments and long-term benefits associated with viral cure.
- Conditions
- Hepatitis C, Chronic, Liver Diseases
- Keywords
- patient-reported outcomes, observational, HCV, Hepatitis C, Liver Disease, Liver, Infectious Disease, PROs
- Medical subject headings
- Hepatitis C, Chronic, Liver Diseases, Hepatitis C, Communicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Total Memorial Symptom Assessment Scale Mean Score (TMSAS) From Baseline to On-Treatment
Change in "Overall Symptom Burden" was measured using the Memorial Symptom Assessment Scale (MSAS). Patients indicate the presence or absence of a symptom, and if present, rate the symptom on severity, frequency and interference. The total MSAS score (TMSAS) can range from 0 (no symptom) to 4 (symptom present and worst severity, frequency and distress). Change in TMSAS score is calculated as Baseline TMSAS mean score minus T2 TMSAS mean score or Baseline TMSAS mean score minus T3 TMSAS mean score.
Change scores could range from +/- 4.0. Higher scores (+) indicate worse symptom burden.
To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful.
Measured: Baseline to up to 24 weeks of HCV Treatment
Secondary outcomes (10)
Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment
Change in Treatment-Related Symptoms was measured using multiple surveys from the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) and the Headache Impact Test (HIT-6). Mean CHANGE Scores were calculated as baseline mean score minus T2 mean score or baseline mean score minus T3 mean score. Lower change scores (-) indicate symptoms improved.
- PROMIS Fatigue-7 mean change score range = +/- 53.9
- PROMIS Sleep Disturbance-8a mean change score range = +/- 47.1
- PROMIS Nausea/Vomiting-4 mean change score range = +/- 44.0
- PROMIS Diarrhea-6 mean change score range = +/- 42.8
- PROMIS Anger-5 mean change score range = +/- 50.5.
- PROMIS Anxiety-4 mean change score range = +/- 41.4
- HIT-6 mean change score range = +/- 42
To aid in interpretation of clinical significance, a 5% change from baseline is considered a "minimally important change (MIC)." The 5% MIC change in a PROMIS or HIT-6 score is +/- 2.5 points.
Measured: Baseline to up to 24 weeks of HCV Treatment
Change in HCV-PRO Mean Scores From Baseline to On-Treatment
HCV-specific Functional Well-Being was measured using the disease-specific "HCV-PRO." The scale includes 16 items that measure physical, emotional and social functioning, productivity, intimacy, and perception of quality of life.
The Means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T2 HCV-PRO mean score or Baseline HCV-PRO mean score minus T3 HCV-PRO mean score.
HCV-PRO mean change scores range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes.
To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful.
Measured: Baseline to up to 24 weeks of HCV Treatment
Cumulative Out of Pocket Costs During HCV Treatment
Cumulative out of pocket (OOP) costs incurred by patients during HCV treatment was measured by a survey recording 5 direct and 5 indirect costs of treatment. OOP costs were collected early on-treatment (T2), late on-treatment (T3), and early post-treatment (T4) in case patients paid bills after treatment ended.
The Mean is the average dollar ($$) amount for Total OOP Cost of HCV Treatment for the cohort, calculated by summing the OOP costs for each patient reported at T2+T3+T4.
Measured: Up to 24 weeks of HCV Treatment
Percentage of Participants With Nonadherence During HCV Treatment
Medication adherence was measured using the Voils' Medication Adherence Survey (VMAS). The VMAS consists of 3 items that evaluated the extent of adherence using a 5-point Likert scale from 1=None of the time to 5=All of the time. The 3 items assess how often participants missed doses, skip doses, or do not take doses over the past 7 days and are averaged into a single score. A dichotomous variable was created to categorize patients as 100% (adherent) or <100% (nonadherent) during HCV treatment at early treatment (T2) and late treatment (T3).
Measured: Up to 24 weeks of HCV Treatment
Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 3-months Post Treatment
Change in "Overall Symptom Burden" from Baseline to 3-months post-treatment was measured using the Memorial Symptom Assessment Scale (MSAS).
The total Overall Symptom Burden mean change score (TMSAS) was calculated as Baseline TMSAS mean score minus T4 TMSAS mean score.
Lower scores (-) indicate better outcomes. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.
TMSAS Mean Change Scores could range from +/- 4.
To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful.
Measured: Baseline to 3-months post-treatment
Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment
Change in Symptoms was measured using surveys below. Change scores were calculated as baseline mean minus T4 mean. Lower change scores (-) indicate symptom improved
- PROMIS Fatigue mean change score range = +/- 53.9
- PROMIS Sleep Disturbance mean change score range = +/- 47.1
- PROMIS Nausea mean change score range = +/- 44.0
- PROMIS Diarrhea mean change score range = +/- 42.8
- PROMIS Anger mean change score range = +/- 50.5.
- PROMIS Anxiety mean change score range = +/- 41.4
- PROMIS Depression mean change score range = +/- 43.1
- PROMIS Cognitive Concern mean change score range = +/- 39.5
- PROMIS Pain mean change score range = +/- 36.4
- PROMIS Belly Pain mean change score range = +/- 50.2
- Headache HIT-6 mean change score range = +/- 42 A 5% change from baseline is considered the clinically "minimally important change" (MIC). The 5% MIC = +/- 2.5 points.
Change scores were calculated for two subgroups: Patients who did and did not achieve SVR
Measured: Baseline to 3-months post-treatment
Change in HCV-PRO Mean Score From Baseline to 3-months Post Treatment
HCV-specific Functional Well-Being was measured using the disease-specific "HCV-PRO."
The means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T4 HCV-PRO mean score. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.
HCV-PRO Mean Change Scores could range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes.
To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful.
Measured: Baseline to 3-months post-treatment
Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 1 Year Post-Treatment
Change in "Overall Symptom Burden" from Baseline to 1 year post-treatment was measured using the Memorial Symptom Assessment Scale (MSAS). The total Overall Symptom Burden mean change score (TMSAS) was calculated as Baseline TMSAS mean score minus T5 TMSAS mean score.
Lower scores (-) indicate better outcomes. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.
TMSAS Mean Change Scores could range from +/- 4. To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful
Measured: Baseline to 1 year post-treatment
Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment
Change in Symptoms was measured using surveys below. Change scores were calculated as baseline mean minus T5 mean. Lower change scores (-) indicate symptom improved
- PROMIS Fatigue mean change score range = +/- 53.9
- PROMIS Sleep Disturbance mean change score range = +/- 47.1
- PROMIS Nausea mean change score range = +/- 44.0
- PROMIS Diarrhea mean change score range = +/- 42.8
- PROMIS Anger mean change score range = +/- 50.5.
- PROMIS Anxiety mean change score range = +/- 41.4
- PROMIS Depression mean change score range = +/- 43.1
- PROMIS Cognitive Concern mean change score range = +/- 39.5
- PROMIS Pain mean change score range = +/- 36.4
- PROMIS Belly Pain mean change score range = +/- 50.2
- Headache HIT-6 mean change score range = +/- 42 A 5% change from baseline is considered the clinically "minimally important change" (MIC). The 5% MIC = +/- 2.5 points.
Change scores were calculated for two subgroups: Patients who did and did not achieve SVR
Measured: Baseline to 1 year post-treatment
Change in HCV-PRO Mean Score From Baseline to 1 Year Post-treatment
HCV-specific Functional Well-Being was measured using the disease-specific "HCV-PRO." The scale includes 16 items that measure physical, emotional and social functioning, productivity, intimacy, and perception of quality of life.
The Means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T5 HCV-PRO mean score.
Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.
HCV-PRO mean change scores could range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes.
To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful.
Measured: Baseline to 1 year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2018
- Study completionJul 2018
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 (4)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,601 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Donna M. Evon, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601820
- Sponsor's protocol ID
- 15-1633
- Acronym
- PROP-UP
- Status last verified
- Oct 2018
- First submitted
- 3 Nov 2015
- Last updated
- 16 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Serper M, Evon DM, Amador J, Stewart PW, Sarkar S, Lok AS, Sterling RK, Reeve BB, Golin CE, Rajender Reddy K, Lim JK, Reau N, Nelson DR, Di Bisceglie AM, Fried MW. Patient-reported outcomes 12 months after hepatitis C treatment with direct-acting antivirals: Results from the PROP UP study. Liver Int. 2021 Apr;41(4):692-704. doi: 10.1111/liv.14781. Epub 2021 Jan 22.
PubMed 33387381Evon DM, Sarkar S, Amador J, Lok AS, Sterling RK, Stewart PW, Reeve BB, Serper M, Reau N, Rajender Reddy K, Di Bisceglie AM, Nelson DR, Golin CE, Lim JK, Fried MW. Patient-reported symptoms during and after direct-acting antiviral therapies for chronic hepatitis C: The PROP UP study. J Hepatol. 2019 Sep;71(3):486-497. doi: 10.1016/j.jhep.2019.04.016. Epub 2019 May 13.
PubMed 31096006Evon DM, Stewart PW, Amador J, Serper M, Lok AS, Sterling RK, Sarkar S, Golin CE, Reeve BB, Nelson DR, Reau N, Lim JK, Reddy KR, Di Bisceglie AM, Fried MW. A comprehensive assessment of patient reported symptom burden, medical comorbidities, and functional well being in patients initiating direct acting antiviral therapy for chronic hepatitis C: Results from a large US multi-center observational study. PLoS One. 2018 Aug 1;13(8):e0196908. doi: 10.1371/journal.pone.0196908. eCollection 2018.
PubMed 30067745Evon DM, Golin CE, Stewart P, Fried MW, Alston S, Reeve B, Lok AS, Sterling RK, Lim JK, Reau N, Sarkar S, Nelson DR, Reddy KR, Di Bisceglie AM. Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment. Contemp Clin Trials. 2017 Jun;57:58-68. doi: 10.1016/j.cct.2017.03.013. Epub 2017 Mar 22.
PubMed 28342989
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Patient-Reported Outcomes Project of HCV-TARGET (PROP UP)
- ClinicalTrials.gov ID
- NCT02601820
- Acronym / sponsor ID
- PROP-UP / 15-1633
- Conditions
- Hepatitis C, Chronic, Liver Diseases
- Keywords
- patient-reported outcomes, observational, HCV, Hepatitis C, Liver Disease, Liver, Infectious Disease, PROs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,601 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Nov 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 10 Nov 2015 (estimated)
- Results
- Posted 16 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PROP UP research study is funded by The Patient Centered Outcomes Research Institute (PCORI). PROP UP is a multi-centered prospective observational study that will evaluate all-oral treatment regimens for chronic hepatitis C viral (HCV) infection regarding several patient-reported outcomes (PROs) such as HCV-associated symptoms, treatment side effects, medication adherence, out of pocket costs, comorbid conditions, and long-term benefits of cure and harms of treatment to compare PROs of different treatment regimens, treatment durations, and patient subgroups. Participants will be recruited from 9 U.S. liver centers. Approximately 1920 patients with HCV infection who are prescribed a regimen containing Sofosbuvir/Ledipasvir(SOF/LED), SOF/Velpatasvir(SOF/VEL), Grazoprevir/Elbasvir(GRZ/ELB), OBV/PTV/r + DSV (PRoD), or daclatasvir/SOF (DAC/SOF) will be recruited and approximately 1600 patients who are approved and begin HCV treatment will be enrolled in the longitudinal study. PRO surveys will be evaluated before, during and after HCV treatment.
PROP UP is a collaborative effort between behavioral and biomedical researchers, a patient engagement group and a patient advocacy organization.
Detailed description
Newer, more effective all-oral regimens for hepatitis C viral (HCV) infection are available. However the available data from industry-sponsored trials do not provide all the information that patients need, nor do these data represent the broad spectrum of patients treated in real-world practice. Trials also exclude disadvantaged subgroups, focus on short-term efficacy and clinician-rated adverse events, rarely obtain the patient's perspective, and do not investigate longer-term harms of treatment or benefits of viral cure. Given these informational gaps, patient-centered outcomes research on treatment harms and benefits that matter most to patients, is needed.
PROP UP is funded by The Patient Centered Outcomes Research Institute (PCORI). PROP UP is a multi-centered prospective observational study that will evaluate newly approved direct acting antiviral (DAA) treatment regimens for HCV regarding several patient-reported outcomes (PROs) such as HCV-associated symptoms, treatment side effects, medication adherence, out of pocket costs, comorbid conditions, and long-term benefits of cure and harms of treatment to compare PROs of different treatment regimens, treatment durations, and patient subgroups.
PROP UP is a collaborative effort between researchers, a patient engagement group, and a patient advocacy organization. Eleven U.S. liver centers will collaborate on PROP UP. Approximately 1920 patients with HCV infection who are prescribed a DAA regimen for chronic HCV will be consented and will complete baseline PRO surveys. Approximately 1600 patients who are approved and begin HCV treatment will be enrolled in the longitudinal study. Participants will complete several PRO surveys at 5 assessment periods during the study: baseline, treatment week 4, end of treatment, 3 months post-treatment, and 12 months post-treatment. PRO survey data will be collected via 3 options: patient home-based computers, tablet, smartphone; phone-administered surveys with a centralized call enter; or at regular clinic visits.
Analysis of PROs collected longitudinally before, during and after treatment for HCV will allow the investigators to answer a variety of questions important to patients and clinicians. Specifically, the investigators will evaluate: (a) prevalence of pre-existing baseline symptoms associated with HCV; (b) the development of new onset treatment side effects and exacerbation of pre-existing symptoms during HCV treatment; (c) medication adherence and out of pocket costs associated with treatment; (d) changes in HCV-associated symptoms and functional status in patients who are cured; (e) long-term patient-reported harms associated with treatments and long-term benefits associated with viral cure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being evaluated for Hep C treatment in 9 large academic liver centers and two private gastroenterology practices in the US.
Key inclusion criteria (9 listed)
- Diagnosed with HCV genotype 1-6
- English-speaking
- Age 21 or older
- Medically cleared and being prescribed one of the following DAA regimens:
Key exclusion criteria (5 listed)
- Inability to provide written informed consent
- Currently participating in a pharmaceutical-sponsored drug trial of hepatitis C treatment
- Major cognitive or mental impairment
- Unable to read or speak English
- Unwilling or unable to complete survey questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the Total Memorial Symptom Assessment Scale Mean Score (TMSAS) From Baseline to On-Treatment
Time frame: Baseline to up to 24 weeks of HCV Treatment
Change in "Overall Symptom Burden" was measured using the Memorial Symptom Assessment Scale (MSAS). Patients indicate the presence or absence of a symptom, and if present, rate the symptom on severity, frequency and interference. The total MSAS score (TMSAS) can range from 0 (no symptom) to 4 (symptom present and worst severity, frequency and distress). Change in TMSAS score is calculated as Baseline TMSAS mean score minus T2 TMSAS mean score or Baseline TMSAS mean score minus T3 TMSAS mean score. Change scores could range from +/- 4.0. Higher scores (+) indicate worse symptom burden. To aid in interpretation of clinically significant change, a >5% change from baseline was set as the "minimally important change (MIC)" threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful.
10 secondary outcomes
Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment
Time frame: Baseline to up to 24 weeks of HCV Treatment
Change in HCV-PRO Mean Scores From Baseline to On-Treatment
Time frame: Baseline to up to 24 weeks of HCV Treatment
Cumulative Out of Pocket Costs During HCV Treatment
Time frame: Up to 24 weeks of HCV Treatment
Percentage of Participants With Nonadherence During HCV Treatment
Time frame: Up to 24 weeks of HCV Treatment
Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 3-months Post Treatment
Time frame: Baseline to 3-months post-treatment
Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment
Time frame: Baseline to 3-months post-treatment
Change in HCV-PRO Mean Score From Baseline to 3-months Post Treatment
Time frame: Baseline to 3-months post-treatment
Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 1 Year Post-Treatment
Time frame: Baseline to 1 year post-treatment
Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment
Time frame: Baseline to 1 year post-treatment
Change in HCV-PRO Mean Score From Baseline to 1 Year Post-treatment
Time frame: Baseline to 1 year post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33387381Serper M, Evon DM, Amador J, Stewart PW, Sarkar S, Lok AS, Sterling RK, Reeve BB, Golin CE, Rajender Reddy K, Lim JK, Reau N, Nelson DR, Di Bisceglie AM, Fried MW. Patient-reported outcomes 12 months after hepatitis C treatment with direct-acting antivirals: Results from the PROP UP study. Liver Int. 2021 Apr;41(4):692-704. doi: 10.1111/liv.14781. Epub 2021 Jan 22.
- Derived from this study: PubMed 31096006Evon DM, Sarkar S, Amador J, Lok AS, Sterling RK, Stewart PW, Reeve BB, Serper M, Reau N, Rajender Reddy K, Di Bisceglie AM, Nelson DR, Golin CE, Lim JK, Fried MW. Patient-reported symptoms during and after direct-acting antiviral therapies for chronic hepatitis C: The PROP UP study. J Hepatol. 2019 Sep;71(3):486-497. doi: 10.1016/j.jhep.2019.04.016. Epub 2019 May 13.
- Derived from this study: PubMed 30067745Evon DM, Stewart PW, Amador J, Serper M, Lok AS, Sterling RK, Sarkar S, Golin CE, Reeve BB, Nelson DR, Reau N, Lim JK, Reddy KR, Di Bisceglie AM, Fried MW. A comprehensive assessment of patient reported symptom burden, medical comorbidities, and functional well being in patients initiating direct acting antiviral therapy for chronic hepatitis C: Results from a large US multi-center observational study. PLoS One. 2018 Aug 1;13(8):e0196908. doi: 10.1371/journal.pone.0196908. eCollection 2018.
- Derived from this study: PubMed 28342989Evon DM, Golin CE, Stewart P, Fried MW, Alston S, Reeve B, Lok AS, Sterling RK, Lim JK, Reau N, Sarkar S, Nelson DR, Reddy KR, Di Bisceglie AM. Patient engagement and study design of PROP UP: A multi-site patient-centered prospective observational study of patients undergoing hepatitis C treatment. Contemp Clin Trials. 2017 Jun;57:58-68. doi: 10.1016/j.cct.2017.03.013. Epub 2017 Mar 22.
- PROP UP Patient WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Donna M. Evon, PhD principal investigator
University of North Carolina, Chapel Hill
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic and Liver Diseases, run by University of North Carolina, Chapel Hill at 11 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 9 inclusion and 5 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 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2019). 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?
Change in the Total Memorial Symptom Assessment Scale Mean Score (TMSAS) From Baseline to On-Treatment (time frame: Baseline to up to 24 weeks of HCV Treatment). 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 NCT02601820, which also lists 4 linked publications.
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 16 Sep 2019.