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NCT02601820 · ClinicalTrials.gov registry record
The Patient-Reported Outcomes Project of HCV-TARGET
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- 1,601
- Enrollment target
NCT02601820: Completed study, sponsored by University of North Carolina, Chapel Hill.
NCT02601820 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 1,601 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02601820 has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- 1,601 participants
- Enrollment target
Study 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.
Primary Outcome
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 scor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,601 participants |
| Start Date | 2015-11 |
| Est. Completion | 2018-07 |
What the finished NCT02601820 record still lists
NCT02601820 is an observational study that tracks outcomes without assigning an intervention. Its 1,601 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT02601820 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02601820 about?
NCT02601820 is a clinical study titled "The Patient-Reported Outcomes Project of HCV-TARGET". 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...
What is the current status of trial NCT02601820?
This trial is currently completed. The enrollment target is 1,601 participants. The study started on 2015-11. Estimated completion is 2018-07.
Who is sponsoring clinical trial NCT02601820?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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