|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03460990 |
|
Date of registration:
|
01/03/2018 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
|
|
Scientific title:
|
A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) |
|
Date of first enrolment:
|
May 1, 2018 |
|
Target sample size:
|
116 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03460990 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Australia
|
Germany
|
Ireland
|
Spain
|
United Kingdom
|
United States
| | |
|
Key inclusion & exclusion criteria
|
Key Inclusion Criteria:
- Homozygous for the F508del mutation (F/F)
- Forced expiratory volume in 1 second (FEV1) value =40% and =90% of predicted mean for
age, sex, and height
Key Exclusion Criteria:
- Clinically significant cirrhosis with or without portal hypertension
- Lung infection with organisms associated with a more rapid decline in pulmonary status
- Solid organ or hematological transplantation
Other protocol defined Inclusion/Exclusion criteria may apply
Age minimum:
12 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Cystic Fibrosis
|
|
Intervention(s)
|
|
Drug: VX-659/TEZ/IVA
|
|
Drug: IVA
|
|
Drug: TEZ/IVA
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
[Time Frame: From Baseline at Week 4]
|
|
Secondary Outcome(s)
|
|
Absolute Change in Sweat Chloride (SwCl)
[Time Frame: From Baseline at Week 4]
|
|
Observed Pre-Dose Concentration (Ctrough) of VX-659, TEZ, TEZ Metabolite (M1-TEZ), and IVA
[Time Frame: From Day 1 and Week 4]
|
|
Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
[Time Frame: From Baseline at Week 4]
|
|
Safety and Tolerability as Assessed Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
[Time Frame: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to Week 8)]
|
|
Secondary ID(s)
|
|
2017-004133-82
|
|
VX17-659-103
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|