EUCTR2012-003990-24-GB
Active, not recruiting
Phase 1
A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
- Sponsor
- Vertex Pharmaceuticals Incorporated
- Enrollment
- 559
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females, aged 12 years or older on the date of informed consent or, where appropriate, date of assent
- •Confirmed diagnosis of CF
- •Homozygous for the F508del CFTR mutation
- •FEV1 \=40% and \=90% of predicted normal for age, sex, and height
- •Willing to remain on a stable CF medication regimen through Week 24 or, if applicable, the Safety Follow up Visit
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 273
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 319
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before first dose of study drug
- •History of solid organ or hematological transplantation
- •History of alcohol or drug abuse in the past year
- •Ongoing or prior participation in an investigational drug study (including studies investigating lumacaftor and/or ivacaftor) within 30 days of screening
- •Use of moderate to strong inhibitors or inducers of CYP3A, including consumption of certain herbal medications (e.g., St. John's Wort) and certain fruit and fruit juices within 14 days before Day 1 of dosing
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsCystic fibrosis in patients homozygous for the F508del-CFTR MutationMedDRA version: 17.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]EUCTR2012-003989-40-NLVertex Pharmaceuticals Incorporated501
Active, not recruiting
Phase 1
A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisEUCTR2018-003986-33-BEArena Pharmaceuticals, Inc.330
Active, not recruiting
Phase 1
A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative ColitisEUCTR2018-003986-33-GBArena Pharmaceuticals, Inc.330
Active, not recruiting
Not Applicable
A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Daily Tadalafil for 12 Weeks in Men with Signs and Symptoms of Benign Prostatic Hyperplasia - LVHJMen with benign prostatic hyperplasiaMedDRA version: 9.1Level: LLTClassification code 10004446Term: Benign prostatic hyperplasiaEUCTR2008-002841-21-ITEli Lilly and Company521
Active, not recruiting
Phase 1
A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsCystic fibrosis in patients homozygous for the F508del-CFTR MutationMedDRA version: 16.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]EUCTR2012-003990-24-DKVertex Pharmaceuticals Incorporated501