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Trial record 74 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

The Patient-Reported Outcomes Project of HCV-TARGET (PROP-UP)

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ClinicalTrials.gov Identifier: NCT02601820
Recruitment Status : Completed
First Posted : November 10, 2015
Results First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date November 3, 2015
First Posted Date November 10, 2015
Results First Submitted Date January 16, 2019
Results First Posted Date September 16, 2019
Last Update Posted Date September 16, 2019
Study Start Date November 2015
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 7, 2019)
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.
Original Primary Outcome Measures
 (submitted: November 6, 2015)
Overall Toxicity measured using the Memorial Symptom Assessment Scale [ Time Frame: Baseline through end of HCV treatment, up to 24 weeks. ]
Overall toxicity of treatment will be measured using the Memorial Symptom Assessment Scale (MSAS). The MSAS is a reliable and validated 32-item instrument that will be used to measure change in pre-existing HCV symptoms and new onset treatment side effects during HCV treatment. The MSAS evaluates 32 prevalent symptoms or side effects that commonly occur in medical populations and during medical treatments. Participants will indicate the presence or absence of a symptom/side effect, and if present, will rate the construct on severity, frequency and interference. An overall treatment toxicity score using all the items will be analyzed, as well as descriptive statistics about change in each symptom/side effect over time.
Change History Complete list of historical versions of study NCT02601820 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 7, 2019)
  • 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 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.
    1. PROMIS Fatigue-7 mean change score range = +/- 53.9
    2. PROMIS Sleep Disturbance-8a mean change score range = +/- 47.1
    3. PROMIS Nausea/Vomiting-4 mean change score range = +/- 44.0
    4. PROMIS Diarrhea-6 mean change score range = +/- 42.8
    5. PROMIS Anger-5 mean change score range = +/- 50.5.
    6. PROMIS Anxiety-4 mean change score range = +/- 41.4
    7. 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.
  • Change in HCV-PRO Mean Scores From Baseline to On-Treatment [ Time Frame: Baseline to up to 24 weeks of HCV 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.
  • Cumulative Out of Pocket Costs During HCV Treatment [ Time Frame: Up to 24 weeks of 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.
  • Percentage of Participants With Nonadherence During HCV Treatment [ Time Frame: Up to 24 weeks of 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).
  • 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 "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.
  • Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment [ Time Frame: 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
    1. PROMIS Fatigue mean change score range = +/- 53.9
    2. PROMIS Sleep Disturbance mean change score range = +/- 47.1
    3. PROMIS Nausea mean change score range = +/- 44.0
    4. PROMIS Diarrhea mean change score range = +/- 42.8
    5. PROMIS Anger mean change score range = +/- 50.5.
    6. PROMIS Anxiety mean change score range = +/- 41.4
    7. PROMIS Depression mean change score range = +/- 43.1
    8. PROMIS Cognitive Concern mean change score range = +/- 39.5
    9. PROMIS Pain mean change score range = +/- 36.4
    10. PROMIS Belly Pain mean change score range = +/- 50.2
    11. 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
  • Change in HCV-PRO Mean Score From Baseline to 3-months Post Treatment [ Time Frame: 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.
  • 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 ]
    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
  • Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment [ Time Frame: 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
    1. PROMIS Fatigue mean change score range = +/- 53.9
    2. PROMIS Sleep Disturbance mean change score range = +/- 47.1
    3. PROMIS Nausea mean change score range = +/- 44.0
    4. PROMIS Diarrhea mean change score range = +/- 42.8
    5. PROMIS Anger mean change score range = +/- 50.5.
    6. PROMIS Anxiety mean change score range = +/- 41.4
    7. PROMIS Depression mean change score range = +/- 43.1
    8. PROMIS Cognitive Concern mean change score range = +/- 39.5
    9. PROMIS Pain mean change score range = +/- 36.4
    10. PROMIS Belly Pain mean change score range = +/- 50.2
    11. 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
  • Change in HCV-PRO Mean Score From Baseline to 1 Year Post-treatment [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: November 6, 2015)
  • Change in Treatment Related Symptoms [ Time Frame: Baseline through end of HCV treatment, up to 24 weeks. ]
    Treatment-related side effects-- fatigue, sleep disturbance, nausea/vomiting, diarrhea, irritability and anxiety-- will be measured using multiple shorts forms developed by the NIIH Patient-Reported Outcomes Measurement Information System® (PROMIS®). The number and severity of each incident will be collected and counted in order to create a report about the aggregate change in overall number of symptoms.
  • Change in HCV-specific functional status [ Time Frame: Baseline through end of HCV treatment, up to 24 weeks. ]
    HCV-specific functional status and well-being will be measured using the HCV-PRO.
  • Cumulative Out of Pocket Costs During HCV Treatment [ Time Frame: Baseline to one year ]
    Cumulative out of pocket costs incurred by patients during HCV treatment will be measured by a survey recording 5 direct and 5 indirect costs of treatment.
  • HCV medication adherence [ Time Frame: Baseline through end of HCV treatment, up to 24 weeks. ]
    Medication adherence will be measured by the Voils' Medication Adherence Survey.
  • Change in HCV symptoms, side effects and functional status 3-months post treatment [ Time Frame: Baseline to 3-months post-treatment ]
    Longitudinal change in HCV-associated symptoms, treatment side effects, and functional status will be evaluated by calculating the aggregate change in symptoms through counting the overall symptoms, etc reported through multiple PROMIS surveys and the HCV-PRO.
  • Changes in HCV symptoms, side effects and functional status 1 year post treatment [ Time Frame: Longitudinal change from baseline to 1 year post-treatment ]
    Longitudinal change in HCV-associated symptoms, treatment side effects, and functional status will be evaluated by calculating the aggregate change in symptoms through counting the overall symptoms, etc reported through multiple PROMIS surveys and the HCV-PRO.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Patient-Reported Outcomes Project of HCV-TARGET
Official Title The Patient-Reported Outcomes Project of HCV-TARGET (PROP UP)
Brief 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 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients being evaluated for Hep C treatment in 9 large academic liver centers and two private gastroenterology practices in the US.
Condition
  • Hepatitis C, Chronic
  • Liver Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 7, 2019)
1601
Original Estimated Enrollment
 (submitted: November 6, 2015)
1600
Actual Study Completion Date July 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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
    • elbasvir/grazoprevir (ELB/GRZ) with or without ribavirin
    • daclatasvir/sofosbuvir, with or without ribavirin (DAC/SOF)
    • sofosbuvir/velpatasvir (SOF/VEL)

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02601820
Other Study ID Numbers 15-1633
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor University of North Carolina, Chapel Hill
Collaborators Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Donna M. Evon, PhD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date October 2018