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Trial record 68 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

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 Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Adherence
Intervention Device: Portal-724 MEMs Cap
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Portal-724 MEMs Cap Real-Time Monitoring Portal-724 MEMs Cap Without Real-Time Monitoring
Hide Arm/Group Description

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

Portal-724 MEMs Cap

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

Portal-724 MEMs Cap

Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Portal-724 MEMs Cap Real-Time Monitoring Portal-724 MEMs Cap Without Real-Time Monitoring Total
Hide Arm/Group Description

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

Portal-724 MEMs Cap

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

Portal-724 MEMs Cap

Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
7
  35.0%
8
  40.0%
15
  37.5%
Male
13
  65.0%
12
  60.0%
25
  62.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 20 participants 20 participants 40 participants
Caucasian
12
  60.0%
14
  70.0%
26
  65.0%
Non-Caucasion
8
  40.0%
6
  30.0%
14
  35.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20
 100.0%
20
 100.0%
40
 100.0%
Treatment Naive  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
18
  90.0%
19
  95.0%
37
  92.5%
1.Primary Outcome
Title 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.
Hide Description Number of Participants with Compliance to Regimen 95% of the Time Due to Portal724-MEMS Service
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Portal-724 MEMs Cap Real-Time Monitoring Portal-724 MEMs Cap Without Real-Time Monitoring
Hide Arm/Group Description:

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

Portal-724 MEMs Cap

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

Portal-724 MEMs Cap

Overall Number of Participants Analyzed 20 20
Measure Type: Count of Participants
Unit of Measure: Participants
19
  95.0%
18
  90.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Portal-724 MEMs Cap Real-Time Monitoring, Portal-724 MEMs Cap Without Real-Time Monitoring
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.548306
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Portal-724 MEMs Cap Real-Time Monitoring Portal-724 MEMs Cap Without Real-Time Monitoring
Hide Arm/Group Description

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

Portal-724 MEMs Cap

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

Portal-724 MEMs Cap

All-Cause Mortality
Portal-724 MEMs Cap Real-Time Monitoring Portal-724 MEMs Cap Without Real-Time Monitoring
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Portal-724 MEMs Cap Real-Time Monitoring Portal-724 MEMs Cap Without Real-Time Monitoring
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Portal-724 MEMs Cap Real-Time Monitoring Portal-724 MEMs Cap Without Real-Time Monitoring
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
A limitation to our pilot study might be the small sample size and a larger study might detect a difference in adherence.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jihad Slim, MD
Organization: Saint Michael's Medical Center
Phone: 9738772663
EMail: jsmdsmmc@gmail.com
Layout table for additonal information
Responsible Party: Jihad Slim, MD, Saint Michael's Medical Center
ClinicalTrials.gov Identifier: NCT02858050     History of Changes
Other Study ID Numbers: 13/16
First Submitted: August 3, 2016
First Posted: August 8, 2016
Results First Submitted: April 25, 2018
Results First Posted: December 11, 2018
Last Update Posted: December 11, 2018