Evaluation of the ReX-C System, in Patients Receiving CFTR Modulators for the Treatment of Cystic Fibrosis (CF).
Evaluation of the Safety, Usability and Efficacy of the ReX-C® System in Medication Management, in Patients Receiving CFTR Modulators (Kalydeco, Orkambi and/or Symdeko) for the Treatment of Cystic Fibrosis (CF).
1 other identifier
interventional
10
1 country
2
Brief Summary
Cystic fibrosis (CF) is a progressive multisystem disorder characterized by abnormalities in the transport of chloride ions in human airway epithelial cells, leading to frequent lung infections, decreased pulmonary function, inability to properly digest food and absorb essential nutrients, and complications with many organs. Patients with CF spend hours daily, in treatments required to manage their disease, including hours of physiotherapy and inhalation and treatment with many daily pills. CF treatment load heavy burden on patients and families and the inevitable consequence of these treatment demands is widespread non-adherence to therapy. CFTR modulators (trade name Kalydeco, Orkambi, Simdeco) is a highly efficient drug approved to treat CF in patients with certain mutations. It is the first drug that treats the underlying cause rather than the symptoms of the disease. It is also one of the most expensive drugs, costing over $300,000 per patient per year. Despite of its proven efficacy and approved reimbursement for certain patients, non-adherence is common among CF patients, resulting from the heavy burden of daily treatment required to manage CF disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2020
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedStudy Start
First participant enrolled
May 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedSeptember 23, 2021
September 1, 2021
2.1 years
December 29, 2019
September 22, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Number of safety events during administration of oral oncolytic medications by ReX-C
Safety events include: pill overdose, pill inhalation during pill ingestion, pill malformation upon dispensing and any severe adverse events related to pill intake by the ReX-C device.
12 months
Rate of subjects feel comfortable to use ReX-C for pill intake and medication managment and define the system as "Easy to use"
At least 70% of subjects: A. Complete at least 6 months with Rex-C. B. Define the system as easy to use and are willing to continue using it for their medication treatment.
12 months
Rate of adherence (number of pill intakes) during treatment with ReX-C
A. Adherence rate when using the ReX-C system is \> 80%. B. Adherence rate is enhanced by the following measures: * At least 80% of missed/ delayed doses recorded by ReX-C are subsequently taken by subjects following real-time reminder communication. * Subject's self-report by adherence questionnaire
12 months
Secondary Outcomes (1)
Rate of improvement in patients health condition when using ReX-C compared with historical data of the same subject, taking identical CFTR modulator in the conventional way
24 months (12 months historical data, before study initiation), 12 months ReX intervention
Study Arms (1)
ReX-C intervention
EXPERIMENTALSubjects use ReX-C to receive CFTR modulators medications. Adherence data, side effects and response to treatment are monitored online in real time via ReX-C cloud.
Interventions
Eligibility Criteria
You may qualify if:
- Male or Female, at least 12 years of age
- Subject is able to swallow pills and during training successfully achieves 2 administrations of "demo" pills (Tic-Tac sweets) by ReX-C.
- Subject is able to read and understand the Informed Consent Form.
- Subject was diagnosed with CF and receives CFTR modulators medication.
- Subject is intended to receive Kalydeco OR Orkambi OR Symdeko during the 12 months study period.
- Subject takes medication therapy at home.
- Subject is fluent in one of the following languages: Hebrew, Arabic.
You may not qualify if:
- Subject has significant physical disability including; poor fine motor skills, impaired visual or auditory faculties, mental disorders or other impairment affecting ability to provide Informed Consent or use the ReX-C dispensing unit effectively.
- Subject failed to extract 2 "demo" pills during ReX-C training.
- Subject is participating in another clinical study that does not permit participation in two studies simultaneously.
- Subject is at end stage or terminal illness with anticipated life expectancy of 6 months or less.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dosentrx Ltd.lead
Study Sites (2)
Hadassah Medical Organization
Jerusalem, Select One, Israel
Carmel Medical Center
Haifa, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Shoseyyov, MD
Hadassah Medical Center, Pediatric department, Jerusalem, Israel
- PRINCIPAL INVESTIGATOR
Galit Livnat-Levanon, MD
Pediatric unit, Lady Davis Carmel Medical Center, Haifa, Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2019
First Posted
January 2, 2020
Study Start
May 12, 2020
Primary Completion
June 30, 2022
Study Completion
July 31, 2022
Last Updated
September 23, 2021
Record last verified: 2021-09