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:
|
EUCTR |
Last refreshed on:
|
19 February 2018 |
Main ID: |
EUCTR2014-004838-25-IT |
Date of registration:
|
30/03/2015 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs
|
Scientific title:
|
A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive |
Date of first enrolment:
|
20/05/2015 |
Target sample size:
|
200 |
Recruitment status: |
Not Recruiting |
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004838-25 |
Study type:
|
Interventional clinical trial of medicinal product |
Study design:
|
Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
|
|
Countries of recruitment
|
Austria
|
Belgium
|
Canada
|
France
|
Germany
|
Ireland
|
Italy
|
United Kingdom
|
United States
| | | | | | | |
Contacts
|
Name:
|
Clinical Trials and Medical Info
|
Address:
|
50 Northern Avenue
02210
Boston, Massachusetts
United States |
Telephone:
|
1877634-8789 |
Email:
|
medical_info@vrtx.com |
Affiliation:
|
Vertex Pharmaceuticals Incorporated |
|
Name:
|
Clinical Trials and Medical Info
|
Address:
|
50 Northern Avenue
02210
Boston, Massachusetts
United States |
Telephone:
|
1877634-8789 |
Email:
|
medical_info@vrtx.com |
Affiliation:
|
Vertex Pharmaceuticals Incorporated |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: • Heterozygous for F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive
• FEV1 =40% and =90% of predicted normal for age, sex, and height during screening
• Stable CF disease as judged by the investigator. Are the trial subjects under 18? yes Number of subjects for this age range: 100 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria: • History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
• Pregnant and nursing females (females of childbearing potential must have a negative pregnancy test at Screening and Week -4 Visits).
• Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
|
Health Condition(s) or Problem(s) studied
|
Cystic Fibrosis MedDRA version: 17.1
Level: PT
Classification code 10011762
Term: Cystic fibrosis
System Organ Class: 10010331 - Congenital, familial and genetic disorders
|
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
|
Intervention(s)
|
Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Not yet assigned CAS Number: 1152311-62-0 Current Sponsor code: VX-661 Other descriptive name: VRT-893661 VRT-0893661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use
|
Primary Outcome(s)
|
Main Objective: To evaluate the efficacy of VX-661 in combination with ivacaftor in subjects with CF who are heterozygous for the F508del mutation on the CFTR gene and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive
|
Secondary Objective: To evaluate the safety of VX-661 in combination with ivacaftor
To investigate the pharmacokinetics (PK) of VX-661 and its metabolites, M1 and M2 (M1-661 and M2-661, respectively) and ivacaftor and its metabolite M1 (M1 ivacaftor)
|
Timepoint(s) of evaluation of this end point: Week 8
|
Primary end point(s): Absolute change in percent predicted forced expiratory volume in 1 second (FEV1) from baseline
|
Secondary Outcome(s)
|
Secondary end point(s): • Relative change in percent predicted FEV1 from baseline through Week 8
• Absolute change in sweat chloride from baseline through Week 8
• Absolute change in Cystic Fibrosis Questionnaire – Revised (CFQ-R) respiratory domain score from baseline through Week 8
• Safety and tolerability assessments based on adverse events (AEs), clinical laboratory values, standard 12-lead electrocardiograms (ECGs), vital signs, and pulse oximetry; from screening through 4 weeks after receiving last dose
• PK parameters of VX-661, M1-661, M2-661, ivacaftor, and M1 ivacaftor through Week 8
|
Timepoint(s) of evaluation of this end point: Weeks 8 and 12
|
Secondary ID(s)
|
VX14-661-109
|
Source(s) of Monetary Support
|
Vertex Pharmaceuticals Incorporated
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|