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Active (not recruiting) Phase 2 2024-517393-13-00

A Phase 2a, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VX-407 in Subjects with Autosomal Dominant Polycystic Kidney Disease Who Have a Subset of PKD1 Gene Variants

Phase 2 – studying effectiveness and dosage
Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Sponsor: Vertex Pharmaceuticals Inc.

trial.available_in: БГ
Overview
Trial status: Authorised Percent change from baseline in htTKV on MRI over time, Safety and tolerability of VX¬407 based on adverse events (AEs), clinical laboratory values (i.e., hematology, serum chemistry, coagulation), standard 12-lead ECGs, and vital signs, Plasma PK parameters of VX 407 Proportion of subjects with percent change from baseline in htTKV ≤0 on MRI over time
Description
Percent change from baseline in htTKV on MRI over time, Safety and tolerability of VX¬407 based on adverse events (AEs), clinical laboratory values (i.e., hematology, serum chemistry, coagulation), standard 12-lead ECGs, and vital signs, Plasma PK parameters of VX 407
Who can participate
Age group: 18-64 years Gender: Female, Male Target enrollment: 11 participants
Interventions
VX-407 tablet
Drug
Locations 6
Belgium (1)
France (1)
Germany (1)
Italy (1)
Netherlands (1)
Spain (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
64 Years
Healthy volunteers
No
Start date
28.11.2025
Registry ID
2024-517393-13-00
Source
euclinicaltrials.eu
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