Clinical trial NCT02858050: Portal-724 MEMS for Medication Adherence Patients Taking HCV Medications
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adherence
Lead sponsor: Saint Michael's Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2016-08-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treatment-naïve and treatment-experienced genotype 1 or 4 HCV patients with or without compensated cirrhosis will be enrolled in this study.

Brief 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

Detailed description: Hepatitis C virus (HCV) infection is a very important health problem worldwide. Majority of the estimated 160 million people infected globally are unaware of their affliction \[1\]. It is a leading cause of chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma. In the United States alone, HCV infection is the most common chronic blood-borne infection, affecting about 3.2 million individuals 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

Eligibility criteria: Inclusion Criteria:

1. Male or female 18 years old and above.
2. HCV treatment naïve or HCV trreatment experienced
3. HCV RNA PCR \> 10,000 IU/L
4. Confirmed infection with Hepatitis C virus (HCV) by HCV serum antibody assay and by HCV Ribonucleic Acid (RNA) Polymerase Chain Reaction (PCR) and Confirmed chronicity with 2 PCR's 6 months apart.
5. Patients with HCV Genotype 1, 4
6. Patients are candidates for treatment of HCV with oral Direct-Acting Agents (DAA)
7. understand the study procedures, alternative treatments available, risks involved with the study, and voluntarily agrees to participate by giving written informed consent

Exclusion Criteria:

1. Patient not willing to sign written informed consent
2. Patients deemed not suitable for HCV treatment as deemed by the treating physician at the liver center
3. Patients with decompensated liver cirrhosis, defined as follows:

   1. Liver biopsy within the last year showing Scheuer Stage 4 or transient elastography (Fibroscan®) in the last year with a reading of \>12.5 kPa; AND
   2. Any clinical sign of hepatic decompensation such as ascites (fluid in the abdomen), jaundice (yellowing of eyes and skin), esophageal varices with bleeding (enlarged veins of the esophagus seen on endoscopy) or hepatic encephalopathy (tremors, confusion, sleepiness)
4. Co-Infection with the Hepatitis B virus
5. Any liver disease of non-HCV etiology such as Hemochromatosis, Wilson's Disease, Alcoholic liver disease or Non-Alcoholic Steato-Hepatitis (NASH)
6. Hepatocellular carcinoma or any other malignancy
7. Untreated psychiatric conditions such as major depression, schizophrenia, bipolar disorder which in the opinion of the Principal Investigator will not interfere with protocol visit and/or procedures
8. Current and untreated substance abuse (cocaine, opiates, alcohol, marijuana, other recreational drugs, controlled substances)
9. Patient is pregnant or breastfeeding.
10. Patients unwilling to use cellular phones
11. Patients unwilling to follow specific instructions for medication intake
12. Patient has any of the following conditions:

    * Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair.
    * Poor venous access that precludes routine peripheral blood sampling required for this trial.
    * History of gastric surgery (e.g., stapling, bypass) or subject with a history of malabsorption disorders (e.g., celiac sprue disease).
    * History of a medical/surgical condition that resulted in hospitalization within the 3 months prior to enrollment, other than for minor elective procedures
    * Medical/surgical conditions that may result in a need for hospitalization during the period of the study
    * any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, TNF antagonists, or other immunosuppressant drugs during the course of the trial
13. has exclusionary laboratory values as listed below: Noncirrhotic/Cirrhotic Subjects Creatinine clearance \< 50 mL/min Hemoglobin \<9.5 g/dL for both male and female subjects Platelets \<50 x 103/μL serum albumin \< 3.0 g/dL INR \>1.7, unless subject has a stable INR on an anticoagulant regimen. HbA1c \>10% ALT \>10XULN AST \>10XULN
14. is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.

Primary outcomes:
measure: Use of Portal724-MEMS Service on Medication Adherence in the Treatment of Hepatitis C in Patients, Defined as Compliance to Regimen 95% of the Time.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Saint Michael's Medical Center
state: New Jersey
Study officials:
affiliation: Saint Micahel's Medical Center
name: Jihad Slim, MD
role: PRINCIPAL_INVESTIGATOR
References: