129Xe for Cystic Fibrosis

University of Virginia, Charlottesville, VA
Cystic Fibrosis129Xe - Drug
Eligibility
6 - 8
All Sexes

Study Summary

This trial will use MRIs to look for effects of a new triple-combination therapy in 6-8 year olds.

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 1 year

1 year
Abdominal T1 values
Lung reader score
Pancreas volume
Ventilation Defect Percentage change from baseline

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Post Trikafta
1 of 2
Pre Trikafta
1 of 2

Experimental Treatment

44 Total Participants · 2 Treatment Groups

Primary Treatment: 129Xe · No Placebo Group · Phase 4

Post Trikafta
Drug
Experimental Group · 1 Intervention: 129Xe · Intervention Types: Drug
Pre Trikafta
Drug
Experimental Group · 1 Intervention: 129Xe · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

University of KansasOTHER
137 Previous Clinical Trials
323,416 Total Patients Enrolled
University of VirginiaOTHER
707 Previous Clinical Trials
1,468,225 Total Patients Enrolled
4 Trials studying Cystic Fibrosis
261 Patients Enrolled for Cystic Fibrosis
University of IowaOTHER
425 Previous Clinical Trials
879,525 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
30 Patients Enrolled for Cystic Fibrosis
Children's Hospital Medical Center, CincinnatiLead Sponsor
772 Previous Clinical Trials
5,425,879 Total Patients Enrolled
20 Trials studying Cystic Fibrosis
981 Patients Enrolled for Cystic Fibrosis

Eligibility Criteria

Age 6 - 8 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

How is 129Xe impacting the wellbeing of individuals?

"There is substantial clinical evidence that 129Xe treatment is safe, leading our team to assign a score of 3." - Anonymous Online Contributor

Unverified Answer

Is enrollment in this experiment still an option for interested participants?

"According to clinicaltrials.gov, this study is presently recruiting participants - the initial posting date was May 1st 2022 and it has since been revised on August 24th of the same year." - Anonymous Online Contributor

Unverified Answer

Am I eligible to join this experiment?

"This clinical investigation is seeking 44 participants with cystic fibrosis aged 6 to 8. Essential eligibility criteria includes: the ability to comply with visit and protocol schedules, sweat chloride levels of 60 mEq/liter or more, two well-documented CFTR gene mutations, written consent from subjects (and assent if applicable), no change in maintenance therapies within 28 days prior to enrollment, willingness to undergo MRI scans and a physician's intent to administer triple combination therapy." - Anonymous Online Contributor

Unverified Answer

What is the limit to how many participants are accepted into this experiment?

"Affirmative. Per clinicaltrials.gov, this medical research project is actively recruiting participants since its initial posting on May 1st 2022 and most recently updated August 24th 2022. 44 individuals need to be enrolled from a single location." - Anonymous Online Contributor

Unverified Answer

Is this research trial open to individuals aged 75 or older?

"According to the study's prerequisites, participants must be between 6 and 8 years old." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.