Trial · NCT02565914
A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation
NCT02565914, Phase 3, Completed, Vertex Pharmaceuticals Incorporated; results first posted 2020-06-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation. Trials, record NCT02565914. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02565914
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Participants With Cystic Fibrosis Who Have an F508del-CFTR Mutation
- NCT number
- NCT02565914
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,131 participants, actual
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Conditions
- Cystic Fibrosis
- Interventions
- TEZ/IVA, IVA
- First posted
- 2015-10-01
- Last updated
- 2023-09-28
- Other registries' IDs
- eudract:2014-004827-29
- Results first posted
- 2020-06-16
Source ClinicalTrials.gov
Registered outcomes37
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 (AEs) and Serious Adverse Events (SAEs) | Day 1 up to Week 100 | |
| Primary | Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs | Day 1 up to Week 100 | |
| Primary | Part C: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to Week 196 | |
| Secondary | Part A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 106/110 Efficacy Set | From Baseline at Study 110 Week 96 | FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Data are reported separately for Placebo-TEZ/IVA category (participants who received placebo in parent study 106 and TEZ/IVA in current study 110) and TEZ/IVA-TEZ/IVA category (participants who received TEZ/IVA in both parent study 106 and in current study 110) as per pre-specified analysis plan. Baseline was defined as the parent study baseline except for Placebo-TEZ/IVA category, for which baseline was study 110 baseline. |
| Secondary | Part A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 108/110 Efficacy Set | From Baseline at Study 110 Week 96 | FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Data are reported separately for Placebo-TEZ/IVA category (participants who received placebo in parent study 108 and TEZ/IVA in current study 110); IVA-TEZ/IVA category (participants who received IVA monotherapy in parent study 108 and TEZ/IVA in current study 110); and TEZ/IVA-TEZ/IVA category (participants who received TEZ/IVA in both parent study 108 and in current study 110) as per pre-specified analysis plan. Baseline was defined as the parent study baseline. |
| Secondary | Part A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 103/110 Efficacy Set | From Baseline at Study 110 Week 96 | FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Data are reported for TEZ/IVA-TEZ/IVA group (participants who received TEZ/IVA in both parent study 103 and in current study 110). Baseline was defined as the parent study baseline. |
| Secondary | Part A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 111/110 Efficacy Set | From Baseline at Study 110 Week 96 | FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Data are reported separately for Placebo-TEZ/IVA category (participants who received placebo in parent study 111 and TEZ/IVA in current study 110) and TEZ/IVA-TEZ/IVA category (participants who received TEZ/IVA in both parent study 111 and in current study 110) as per pre-specified analysis plan. Baseline was defined as the parent study baseline. |
| Secondary | Part A: Relative Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 106/110 Efficacy Set | From Baseline at Study 110 Week 96 | FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Data are reported separately for Placebo-TEZ/IVA category (participants who received placebo in parent study 106 and TEZ/IVA in current study 110) and TEZ/IVA-TEZ/IVA category (participants who received TEZ/IVA in both parent study 106 and in current study 110) as per pre-specified analysis plan. Baseline was defined as the parent study baseline except for Placebo-TEZ/IVA category, for which baseline was study 110 baseline. |
| Secondary | Part A: Relative Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 108/110 Efficacy Set | From Baseline at Study 110 Week 96 | FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Data are reported separately for Placebo-TEZ/IVA category (participants who received placebo in parent study 108 and TEZ/IVA in current study 110); IVA-TEZ/IVA category (participants who received IVA monotherapy in parent study 108 and TEZ/IVA in current study 110); and TEZ/IVA-TEZ/IVA category (participants who received TEZ/IVA in both parent study 108 and in current study 110) as per pre-specified analysis plan. Baseline was defined as the parent study baseline. |
| Secondary | Part A: Relative Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 103/110 Efficacy Set | From Baseline at Study 110 Week 96 | FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Data are reported for TEZ/IVA-TEZ/IVA group (participants who received TEZ/IVA in both parent study 103 and in current study 110). Baseline was defined as the parent study baseline. |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
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 (AEs) and Serious Adverse Events (SAEs) | Day 1 up to Week 100 | Safety Set was defined as all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs | Day 1 up to Week 100 | Safety set included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part C: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to Week 196 | Safety set included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 106/110 Efficacy Set | From Baseline at Study 110 Week 96 | The 106/110 efficacy set included all enrolled participants who received at least 1 dose of study drug in Part A and rolled over from parent study 106 and had pre-defined CFTR genotypes. | percentage points | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 108/110 Efficacy Set | From Baseline at Study 110 Week 96 | The 108/110 efficacy set included all enrolled participants who received at least 1 dose of study drug in Part A and rolled over from parent study 108 and had pre-defined CFTR genotypes. | percentage points | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 103/110 Efficacy Set | From Baseline at Study 110 Week 96 | The 103/110 efficacy set included all enrolled participants who received at least 1 dose of study drug in Part A and rolled over from parent study 103 and had pre-defined CFTR genotypes. | percentage points | MEAN |
| SECONDARY | Part A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 111/110 Efficacy Set | From Baseline at Study 110 Week 96 | The 111/110 efficacy set included all enrolled participants who received at least 1 dose of study drug in Part A and rolled over from parent study 111 and had pre-defined CFTR genotypes. | percentage points | MEAN |
| SECONDARY | Part A: Relative Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 106/110 Efficacy Set | From Baseline at Study 110 Week 96 | The 106/110 efficacy set included all enrolled participants who received at least 1 dose of study drug in Part A and rolled over from parent study 106 and had pre-defined CFTR genotypes. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Relative Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 108/110 Efficacy Set | From Baseline at Study 110 Week 96 | The 108/110 efficacy set included all enrolled participants who received at least 1 dose of study drug in Part A and rolled over from parent study 108 and had pre-defined CFTR genotypes. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Part A: Relative Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 103/110 Efficacy Set | From Baseline at Study 110 Week 96 | The 103/110 efficacy set included all enrolled participants who received at least 1 dose of study drug in Part A and rolled over from parent study 103 and had pre-defined CFTR genotypes. | percent change | MEAN |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group81
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 (AEs) and Serious Adverse Events (SAEs) | Part A: TEZ/IVA | Participants with TEAEs | 995 | Participants | |
| Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part A: TEZ/IVA | Participants with SAEs | 351 | Participants | |
| Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs | Part B: TEZ/IVA | Participants with TEAEs | 427 | Participants | |
| Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs | Part B: TEZ/IVA | Participants with SAEs | 136 | Participants | |
| Part C: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part C: TEZ/IVA | Participants with TEAEs | 168 | Participants | |
| Part C: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part C: TEZ/IVA | Participants with SAEs | 44 | Participants | |
| Part A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 106/110 Efficacy Set | Part A: TEZ/IVA | Placebo-TEZ/IVA: Change at Week 96 | 2.1 | 95% Confidence Interval 0.8 to 3.3 | percentage points |
| Part A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 106/110 Efficacy Set | Part A: TEZ/IVA | TEZ/IVA-TEZ/IVA: Change at Week 96 | 2.0 | 95% Confidence Interval 0.7 to 3.2 | percentage points |
| Part A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 108/110 Efficacy Set | Part A: TEZ/IVA | Placebo-TEZ/IVA: Change at Week 96 | 4.1 | 95% Confidence Interval 2.2 to 6.0 | percentage points |
| Part A: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 108/110 Efficacy Set | Part A: TEZ/IVA | IVA-TEZ/IVA: Change at Week 96 | 6.7 | 95% Confidence Interval 4.7 to 8.7 | percentage points |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A (Up to 96 Weeks) | STARTED | TEZ/IVA | 1,044 | |
| Part A (Up to 96 Weeks) | Safety Set | TEZ/IVA | 1,042 | |
| Part A (Up to 96 Weeks) | COMPLETED | TEZ/IVA | 951 | |
| Part A (Up to 96 Weeks) | NOT COMPLETED | TEZ/IVA | 93 | |
| Part B (Up to 96 Weeks) | STARTED | TEZ/IVA | 464 | |
| Part B (Up to 96 Weeks) | Safety Set | TEZ/IVA | 463 | |
| Part B (Up to 96 Weeks) | COMPLETED | TEZ/IVA | 228 | |
| Part B (Up to 96 Weeks) | NOT COMPLETED | TEZ/IVA | 236 | |
| Part C (Up to 192 Weeks) | STARTED | TEZ/IVA | 204 | |
| Part C (Up to 192 Weeks) | Safety Set | TEZ/IVA | 204 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events675
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: TEZ/IVA | 101 | 1,042 | |
| other | Abdominal pain | Gastrointestinal disorders | Part B: TEZ/IVA | 35 | 463 | |
| other | Abdominal pain | Gastrointestinal disorders | Part C: TEZ/IVA | 7 | 204 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Part A: TEZ/IVA | 44 | 1,042 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Part B: TEZ/IVA | 26 | 463 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Part C: TEZ/IVA | 2 | 204 | |
| other | Constipation | Gastrointestinal disorders | Part A: TEZ/IVA | 69 | 1,042 | |
| other | Constipation | Gastrointestinal disorders | Part B: TEZ/IVA | 24 | 463 | |
| other | Constipation | Gastrointestinal disorders | Part C: TEZ/IVA | 8 | 204 | |
| other | Diarrhoea | Gastrointestinal disorders | Part A: TEZ/IVA | 105 | 1,042 |
1 to 10 of 675Source ClinicalTrials.gov
See all 675 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: TEZ/IVA | 1 | 1,042 |
| Total, all-cause mortality | Part B: TEZ/IVA | 0 | 463 |
| Total, all-cause mortality | Part C: TEZ/IVA | 0 | 204 |
| Total, other adverse events | Part A: TEZ/IVA | 938 | 1,042 |
| Total, other adverse events | Part B: TEZ/IVA | 391 | 463 |
| Total, other adverse events | Part C: TEZ/IVA | 149 | 204 |
| Total, serious adverse events | Part A: TEZ/IVA | 351 | 1,042 |
| Total, serious adverse events | Part B: TEZ/IVA | 136 | 463 |
| Total, serious adverse events | Part C: TEZ/IVA | 44 | 204 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33581080 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02565914
GET https://conductscience.org/api/trials/v1/NCT02565914/registered?page=2