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NCT03445793 · ClinicalTrials.gov registry record

: TRANSITION: An Observational Study of Transition From Lumacaftor/Ivacaftor to Tezacaftor/Ivacaftor (Tez/Iva)

A clinical trial of Cystic Fibrosis (CF), sponsored by National Jewish Health.

Completed
Registry status
5
Enrollment target
1
Study location

NCT03445793: Completed study of Cystic Fibrosis (CF), sponsored by National Jewish Health.

NCT03445793 is a study of Cystic Fibrosis (CF) that has completed, run by National Jewish Health. The registered enrollment target is 5 participants, below the 141-participant average among 14 other Cystic Fibrosis (CF) trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03445793, a study of Cystic Fibrosis (CF), has completed, sponsored by National Jewish Health.

COMPLETED
Registry status
5 participants
Enrollment target
1
Study location

Study Summary

This study is a single center study of clinical and laboratory outcomes in patients ≥ 12 who transition from use of Orkambi to tez/iva. Clinical and laboratory measurements will be measured at baseline, 1 month, 3 months, and 6 months after initiation of tez/iva. Change from baseline at 6 months pre-specified will be reported. The length of study participation will be approximately 6 months.

Primary Outcome

Sweat chloride is a measure of cystic fibrosis transmembrane conductance regulator function. The calculations represent the average change from baseline to the average change at 6 months.

Conditions Studied

Study Locations (1)

Colorado

  • National Jewish Heatlh - Denver

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2018-03-01
Est. Completion 2019-11-01
National Jewish Health

83 total trials

What the finished NCT03445793 record still lists

NCT03445793 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 141-participant average among 14 other Cystic Fibrosis (CF) trials with a reported enrollment target (96% lower).

The record links to 1 condition, with Cystic Fibrosis (CF) appearing as the primary indexed condition, and to 0 interventions.

NCT03445793 reports a single indexed study location in Colorado.

Frequently Asked Questions

What is clinical trial NCT03445793 about?

NCT03445793 is a clinical study titled ": TRANSITION: An Observational Study of Transition From Lumacaftor/Ivacaftor to Tezacaftor/Ivacaftor (Tez/Iva)". This study is a single center study of clinical and laboratory outcomes in patients ≥ 12 who transition from use of Orkambi to tez/iva. Clinical and laboratory measurements will be measured at baseline, 1 month, 3 months, and 6 months after initiation of tez/iva. Change from baseline at 6 months pre...

What is the current status of trial NCT03445793?

This trial is currently completed. The enrollment target is 5 participants. The study started on 2018-03-01. Estimated completion is 2019-11-01.

What conditions does trial NCT03445793 study?

This clinical trial studies the following conditions: Cystic Fibrosis (CF).

Who is sponsoring clinical trial NCT03445793?

This trial is sponsored by National Jewish Health, which has 83 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03445793 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Cystic Fibrosis (CF)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03445793's enrollment target sits among peer trials

5 15th of 14 the lowest of 14 other Cystic Fibrosis (CF) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cystic Fibrosis (CF) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03445793, the US trial registry maintained by the National Library of Medicine. NCT03445793 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.