Cystic fibrosis
Conditions
Interventions
Trade Name: Orkambi: contains lumacaftor and ivacaftor
Product Name: Orkambi
Pharmaceutical Form: Coated tablet
Trade Name: Symkevi
Product Name: Symkevi
Pharmaceutical Form: Coated tablet
Trade Nam
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • The subject is homozygous for the F508del mutation in the CFTR gene. • The subject is aged 18 years or older. • The subject used Orkambi continuous for at least a month before enrolling in the study. • The subject used Orkambi in a dose of twice-daily 2 tablets of 200/125 mg lum/iva. • The subject will switch from Orkambi therapy to Symkevi. • The subject will initiate Symkevi therapy with a dosage of once-daily 1 tablet of 100/150 mg TEZ/IVA and once-daily 1 tablet of 150 mg IVA • The subject has signed and dated a written informed consent. Are the trial subjects under 18? no 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 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • The subject is deemed unfit to participate in this study by the treating physician. • The subject is experiencing an exacerbation needing treatment with IV antibiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study endpoint is the ivacaftor through concentration.;Secondary Objective: - tezacaftor and lumacaftor through concentrations - hydroxymethyl-ivacaftor and ivacaftor-carboxylate concentrations - ivacaftor, tezacaftor and lumacaftor concentration at T-max;Primary end point(s): - The primary study endpoint is the ivacaftor through concentration.;Timepoint(s) of evaluation of this end point: After at least one month of treatment with Orkambi, just before subject is supposed to take the next morning dose Orkambi After at least one month of treatment with Symkevi, just before subject is supposed to take the next morning dose Symkevi | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - tezacaftor and lumacaftor through concentrations - hydroxymethyl-ivacaftor and ivacaftor-carboxylate concentrations - ivacaftor, tezacaftor and lumacaftor concentration at T-max;Timepoint(s) of evaluation of this end point: After at least one month of treatment with Orkambi, 3-5 hours after subject has taken morning dose Orkambi After at least one month of treatment with Symkevi, 3-5 hours after subject has taken morning dose Symkevi | — |
Countries
Netherlands
Outcome results
None listed