Trial · NCT04043806
A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
NCT04043806, Phase 3, Completed, Vertex Pharmaceuticals Incorporated; results first posted 2023-07-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Evaluating the Long-term Safety of VX-445 Combination Therapy. Trials, record NCT04043806. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04043806
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
- NCT number
- NCT04043806
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 458 participants, actual
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Conditions
- Cystic Fibrosis
- Interventions
- ELX/TEZ/IVA, IVA
- First posted
- 2019-08-02
- Last updated
- 2023-07-06
- Other registries' IDs
- eudract:2018-004652-38
- Results first posted
- 2023-07-06
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From Baseline through Week 100 |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From Baseline through Week 100 | Safety set for included all participants who received at least 1 dose of study drug. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | ELX/TEZ/IVA | Participants with TEAEs | 435 | participants | |
| Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | ELX/TEZ/IVA | Participants with SAEs | 75 | participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ELX/TEZ/IVA | 458 | |
| Overall Study | Safety Set | ELX/TEZ/IVA | 457 | |
| Overall Study | COMPLETED | ELX/TEZ/IVA | 412 | |
| Overall Study | NOT COMPLETED | ELX/TEZ/IVA | 46 |
Source ClinicalTrials.gov
Adverse events178
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Part A: ELX/TEZ/IVA | 30 | 457 | |
| other | Abdominal pain | Gastrointestinal disorders | Part B: ELX/TEZ/IVA | 2 | 66 | |
| other | Diarrhoea | Gastrointestinal disorders | Part A: ELX/TEZ/IVA | 33 | 457 | |
| other | Diarrhoea | Gastrointestinal disorders | Part B: ELX/TEZ/IVA | 1 | 66 | |
| other | Nausea | Gastrointestinal disorders | Part A: ELX/TEZ/IVA | 40 | 457 | |
| other | Nausea | Gastrointestinal disorders | Part B: ELX/TEZ/IVA | 2 | 66 | |
| other | Vomiting | Gastrointestinal disorders | Part A: ELX/TEZ/IVA | 25 | 457 | |
| other | Vomiting | Gastrointestinal disorders | Part B: ELX/TEZ/IVA | 6 | 66 | |
| other | Fatigue | General disorders | Part A: ELX/TEZ/IVA | 46 | 457 | |
| other | Fatigue | General disorders | Part B: ELX/TEZ/IVA | 4 | 66 |
1 to 10 of 178Source ClinicalTrials.gov
See all 178 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: ELX/TEZ/IVA | 0 | 457 |
| Total, all-cause mortality | Part B: ELX/TEZ/IVA | 0 | 66 |
| Total, other adverse events | Part A: ELX/TEZ/IVA | 404 | 457 |
| Total, other adverse events | Part B: ELX/TEZ/IVA | 45 | 66 |
| Total, serious adverse events | Part A: ELX/TEZ/IVA | 75 | 457 |
| Total, serious adverse events | Part B: ELX/TEZ/IVA | 4 | 66 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Part A: ELX/TEZ/IVA vs Part B: ELX/TEZ/IVA: deaths from any cause | Trial comparisons |
| Part A: ELX/TEZ/IVA vs Part B: ELX/TEZ/IVA: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04043806
GET https://conductscience.org/api/trials/v1/NCT04043806/events?page=2