Phase 3 Cystic Fibrosis Trial, Completed NCT04043806 Sponsor: Vertex Pharmaceuticals Incorporated Condition: Cystic Fibrosis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT04043806) enrolled 458 participants who were given a combination treatment referred to as ELX/TEZ/IVA. The trial was measuring the safety and tolerability of this treatment — in other words, it was looking at whether participants experienced any unwanted health events while taking it. Of the 458 who started, 412 completed the trial, while 46 did not finish. The reported data shows that the main (primary) outcome being tracked was the number of participants who experienced what are called "treatment-emergent adverse events" (TEAEs) — meaning any unwanted health events that appeared or worsened after starting the treatment — as well as "serious adverse events" (SAEs), which are more severe health events requiring significant medical attention. According to the results reported on ClinicalTrials.gov, 435 participants were reported as experiencing at least one treatment-emergent adverse event, and 75 participants were reported as experiencing at least one serious adverse event. No further breakdown of these numbers — such as what types of events occurred or how often — was available in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Cystic Fibrosis Trial, Completed

NCT04043806
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are currently taking part in a specific related clinical study called VX17-659-105 (also known as NCT03447262)

Who may not be able to join:

  • You had a bad reaction to the study drug during the VX17-659-105 study that the doctors believe could put you at extra risk if you continued
  • You are currently enrolled in another clinical trial testing an experimental drug (other than the VX17-659-105 study)

Important: The trial organisers note that there may be additional eligibility requirements beyond those listed here. Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Australian sites

Royal Adelaide Hospital, Adelaide,
The Prince Charles Hospital, Chermside,
Alfred Hospital, Melbourne, VIC,
Institute for Respiratory Health, Nedlands,
Perth Children's Hospital, Nedlands,
John Hunter Hospital & Hunter Medical Research Institute and John Hunter Children's Hospital, New Lambton,
Queensland Children's Hospital, South Brisbane,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
9 August 2019
Est. completion
14 December 2022

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇩🇰 Denmark 🇩🇪 Germany 🇮🇪 Ireland 🇮🇱 Israel 🇵🇱 Poland 🇪🇸 Spain 🇨🇭 Switzerland 🇬🇧 United Kingdom 🇺🇸 United States

7 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov