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Clinical Trials/EUCTR2009-010261-23-Outside-EU/EEA
EUCTR2009-010261-23-Outside-EU/EEA
Active, not recruiting
Not Applicable

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of VX-770 in Subjects Aged 12 Years and Older With Cystic Fibrosis who are Homozygous for the F508del-CFTR Mutation - DISCOVER

Vertex Pharmaceuticals Incorporated0 sites140 target enrollmentJune 6, 2011
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ConditionsCystic FibrosisMedDRA version: 13.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cystic Fibrosis
Sponsor
Vertex Pharmaceuticals Incorporated
Enrollment
140
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 6, 2011
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Male or female with confirmed diagnosis of CF
  • •\- Must be homozygous for the F508del\-CFTR mutation.
  • •\- FEV1 40% or greater of predicted normal
  • •\- 12 years of age or older
  • •\- Females of child\-bearing potential must have a negative serum pregnancy test at Screening
  • •\- Subjects of child\-bearing potential and who are sexually active must meet the contraception requirements
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 50
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 90

Exclusion Criteria

  • •\- 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
  • •\- An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before Day 1
  • •\- History of solid organ or hematological transplantation
  • •\- History of alcohol, medication, or illicit drug abuse within one year prior to Day 1
  • •\- Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 30 days prior to Screening.
  • •\- Use of inhaled hypertonic saline treatment.
  • •\- Concomitant use of any inhibitors or inducers of CYP3A4

Outcomes

Primary Outcomes

Not specified

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