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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 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.

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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.

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

Sponsor

National Jewish Health

83 total trials

What the Registry Record Tells You About NCT03445793

The ClinicalTrials.gov registry entry for NCT03445793 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 141-participant average among 14 other Cystic Fibrosis (CF) trials with a reported enrollment target (96% lower). The listed sponsor is National Jewish Health, which has 83 total studies on file at ClinicalTrials.gov.

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

NCT03445793 reports 1 study location spanning 1 distinct geographic area - top geographies include 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)

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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