At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓HCV treatment-naïve or treatment-experienced
- ✓HCV RNA PCR >10,000 IU/L
- ✓Confirmed HCV infection by serology and RNA PCR with chronicity documented by 2 PCR tests 6 months apart
- ✕Decompensated liver cirrhosis: fibrosis stage 4 on biopsy or >12.5 kPa on fibroscan AND clinical signs of decompensation (ascites, jaundice, esophageal varices with bleeding, or hepatic encephalopathy)
- ✕Hepatitis B virus co-infection
- ✕Non-HCV liver disease (hemochromatosis, Wilson disease, alcoholic liver disease, NASH)
- ✕Hepatocellular carcinoma or other active malignancy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Parallel-group, Pilot Study on the Effect of Using the Portal724-Medication Electronic Medication System (MEMS) Smart Cap With Real-time Medication Adherence Among Patients Being Treated With Grazoprevir/Elbasvir
In Brief
An observational study evaluating Portal-724 MEMs Cap for Adherence. Completed, enrolled 40 participants across 1 site.
Detailed Summary
The study will look at real-time adherence monitoring with Portal-724 MEMS cap. It integrates medication bottle, Smart Cap, Pill Dispenser, Embedded Computer, Embedded Cellular Modem and Tamper Proof apparatus. This device is capable of transmitting pill dispensing events from the patient's home to the Cloud over Cellular and IP networks. The transmission is done in real time if cellular coverage is above 1-bar, but if the cell signal is not available or if the signal is below the threshold, then the device Store-and-Forward feature is automatically activated. The patient will be randomized to real-time monitoring or to have monitoring data download monthly at each study visit while taking hepatitis C medications