|
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:
|
13 December 2021 |
|
Main ID: |
EUCTR2009-012997-11-FR |
|
Date of registration:
|
27/04/2010 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST
|
|
Scientific title:
|
An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST |
|
Date of first enrolment:
|
25/08/2010 |
|
Target sample size:
|
217 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-012997-11 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
|
|
|
Countries of recruitment
|
|
Czech Republic
|
France
|
Germany
|
Ireland
|
United Kingdom
| | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
- Subjects who have completed the assigned study treatment Study 102 or Study 103 who meet certain criteria.
- Subjects who are females of childbearing potential must have a negative urine pregnancy test on Day 1 (first dose of VX-770).
- Subjects who are able to understand and comply with protocol requirements, restrictions, and instructions and likely to complete the study as planned, as judged by the investigator.
- Subjects of child bearing potential and who are sexually active must meet the contraception requirements.
- Subjects must sign the informed consent form (ICF), and where appropriate, assent must be obtained.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
- Subjects with a history of any illness or condition 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.
- Subjects with a history of study treatment intolerance as observed in their previous VX 770 study that, in the opinion of the investigator, might pose an additional risk in administering study drug to the subject.
- Subjects who are pregnant, planning a pregnancy, breast-feeding, or not willing to follow contraception requirements.
- Subjects taking any inhibitors or inducers of CYP3A4, including certain herbal medications (e.g., St. John’s Wort) and grapefruit/grapefruit juice.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Cystic Fibrosis
MedDRA version: 12.1
Level: LLT
Classification code 10011762
Term: Cystic fibrosis
|
|
Intervention(s)
|
Product Name: VX-770
Product Code: VX-770, VRT-8130077
Pharmaceutical Form: Tablet
CAS Number: 873054-44-5
Current Sponsor code: VX-770
Other descriptive name: VRT-813077
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
|
|
Primary Outcome(s)
|
|
Primary end point(s): Safety as determined by adverse events, clinical laboratory values (serum chemistry, hematology, coagulation studies, and urinalysis), standard digital ECGs, vital signs, and physical examinations
|
Secondary Objective: To evaluate the efficacy of long-term VX-770 treatment in subjects with CF
|
Main Objective: To evaluate the safety of long-term VX-770 treatment in subjects with cystic fibrosis (CF)
|
|
Secondary ID(s)
|
|
VX08-770-105
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date: 25/08/2010
Contact:
|
|