Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Portal-724 MEMS for Medication Adherence Patients Taking HCV Medications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02858050
Recruitment Status : Completed
First Posted : August 8, 2016
Results First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Jihad Slim, MD, Saint Michael's Medical Center

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment
Adherence Device: Portal-724 MEMs Cap

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
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 9, 2016
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : January 25, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
MEMs Cap Real-Time Monitoring
Group 1 will consist of patient taking hepatitis C medicaitons and will have Portal-724 MEMs cap place in their medication bottle and will transmit data in real-time
 Device: Portal-724 MEMs Cap
MEMs Cap Without Real-Time Monitoring
Group 2 will consist of patient taking hepatitis C medicaitons and will have Portal-724 MEMs cap place in their medication bottle and data will be downloaded at each study visit while taking hepatitis C medications
 Device: Portal-724 MEMs Cap


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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. [ Time Frame: 1 year ]
    Number of Participants with Compliance to Regimen 95% of the Time Due to Portal724-MEMS Service


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858050


Locations
Layout table for location information
United States, New Jersey
Saint Michael's Medical Center
Newark, New Jersey, United States, 07102
Sponsors and Collaborators
Saint Michael's Medical Center
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Principal Investigator: Jihad Slim, MD Saint Micahel's Medical Center
  Study Documents (Full-Text)

Documents provided by Jihad Slim, MD, Saint Michael's Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] March 9, 2016

More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jihad Slim, MD, Chief and Program Director, Infectious Diseases, Saint Michael's Medical Center
ClinicalTrials.gov Identifier: NCT02858050    
Other Study ID Numbers: 13/16
First Posted: August 8, 2016    Key Record Dates
Results First Posted: December 11, 2018
Last Update Posted: December 11, 2018
Last Verified: December 2018