Brief description of trial (Data source: BASEC)
Vertex Pharmaceuticals sponsert eine Studie, um festzustellen, ob die Prüfmedikamente VX-445, Tezacaftor und Ivacaftor sicher sind und Menschen mit Mukoviszidose helfen können. Patienten, die teilnehmen möchten,
müssen 12 Jahren oder älter sein, die Einschlusskriterien für die Studie erfüllen und bereits in der klinischen Studie VX17-659-105 in Behandlung sein. Die Studienteilnehmer erhalten morgens 2 Tabletten VX-445, Tezacaftor und Ivacaftor und abends eine Tablette Ivacaftor über einen Zeitraum von 96 Wochen (ca. 2 Jahren).
Health conditions investigated(Data source: BASEC)
Mukoviszidose
Health conditions
(Data source: WHO)
Cystic Fibrosis
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Alle Patienten werden eine Dreifachkombination aus VX-445, TEZ und IVA erhalten.
Morgens: VX-445 (200 mg), TEZ (100 mg) und IVA (150 mg) als 2 Tabletten
Abends: IVA (150 mg) als 1 Tablette
Interventions
(Data source: WHO)
Drug: ELX/TEZ/IVA;Drug: IVA
Criteria for participation in trial
(Data source: BASEC)
Patienten in der Behandlungsphase der Vertex-Studie VX17-659-105
Exclusion criteria
(Data source: BASEC)
-Bekannte Arzneimittelunverträglichkeit, die nach Ansicht des Prüfarztes ein
zusätzliches Risiko für den Studienteilnehmer darstellt
- Aktuelle Teilnahme an einer anderen klinisches Studie statt VX17-659-105
- Schwangere oder stillende Frauen
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- Currently participating in study VX17-659-105 (NCT03447262)
Exclusion Criteria:
- History of drug intolerance in study VX17-659-105 that would pose an additional risk
to the subject in the opinion of the investigator
- Current participation in an investigational drug trial (other than study VX17-659-105)
Other protocol defined Inclusion/Exclusion criteria may apply
-
Further information on trial
Date trial registered
Jul 31, 2019
Incorporation of the first participant
Aug 9, 2019
Recruitment status
Completed
Academic title
(Data source: WHO)
A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Safety and tolerability as assessed by number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Bern, Zurich
Countries
(Data source: WHO)
Australia, Canada, Denmark, Germany, Ireland, Israel, Poland, Spain, Switzerland, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Dr. Sabine Albrecht, Associate Medical Director
+41 (0)41 560 05 00
sabine_albrecht@vrtx.com
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
26.09.2019
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2019-01492
Secondary ID (Data source: WHO)
2018-004652-38
VX18-445-113
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