Status:
COMPLETED
Study of LAU-7b in the Treatment of Cystic Fibrosis in Adults
Lead Sponsor:
Laurent Pharmaceuticals Inc.
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
An International Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of LAU-7b administered once-daily for 6 months for the treatment of CF.
Detailed Description
An International Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of LAU-7b administered once-daily for 6 months for the treatment of CF. All patients w...
Eligibility Criteria
Inclusion
- Screening FEV1 between 40% and 100% predicted value for age, gender and height, in patients capable of properly performing the test;
- History of pulmonary exacerbation, defined as at least one (1) pulmonary exacerbation in the year prior to Screening which resulted in documented intravenous or Oral antibiotics;
- Patients are eligible independently of their history of pulmonary Pseudomonas aeruginosa (PsA) infection and their PsA status at screening;
- If taking Kalydeco® (ivacaftor), Orkambi® (ivacaftor/lumacaftor), Symdeko® (ivacaftor/tezacaftor) or other commercially available CFTR modulator products, patients must be taking it for a minimum of 3 months prior to screening if naïve to CFTR modulators and 1 month if switched from another CFTR modulator product and deemed to tolerate it;
- No change in CF and allowed systemic chronic therapy for a minimum of 5 weeks prior to randomization, of which 2 weeks minimum are prior to screening;
- Female patients of child bearing potential should be on highly effective contraceptive methods during the study;
- Male patients with spouse or partner of child bearing potential, or pregnant, are eligible if they use an appropriate method of contraception.
Exclusion
- Pregnancy: due to the potential teratogenic effects of retinoids, pregnant women are NOT eligible;
- Breast milk feeding by study patient is NOT allowed;
- Clinically abnormal renal function: serum creatinine \> 132 μM (1.5 mg/dL);
- Clinically abnormal liver function: Total bilirubin \>1.5 x ULN (in the absence of demonstrated Gilbert's syndrome), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 2.5 x ULN;
- Patients with plasma retinol levels below 0.7 µM;
- Presence of nyctalopia or hemeralopia at enrolment, or any other serious retinal, ophthalmological condition;
- Presence of serious dermatological conditions at entry, including inflammatory or xerotic skin pathologies such as psoriasis or ichthyosis;
- Intake of chronic systemic steroids in the month prior to screening and during the study;
- History of acute infections (viral/bacterial/fungal) within 5 weeks prior to randomization, of which 2 weeks minimum are prior to screening, whether or not treated and resolved;
- Presence of infection with Burkholderia cepacia (including all species within the Burkholderia cepacia complex group, and Burkholderia gladioli) in the 12 months prior to screening;
- Patients with a confirmed diagnosis (as per the Cystic Fibrosis Foundation diagnostic criteria) of Allergic BronchoPulmonary Aspergillosis (ABPA) and actively being treated with corticosteroids and/or anti fungal agents.
Key Trial Info
Start Date :
November 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2021
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT03265288
Start Date
November 5 2018
End Date
September 15 2021
Last Update
October 9 2024
Active Locations (40)
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1
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
2
Children's Hospital Los Angeles
Los Angeles, California, United States, 90227
3
UC Davis Medical Center, Division of Pulmonary & Critical Care Medicine
Sacramento, California, United States, 95817
4
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010