A Phase 2 Open Label Extension Study in Participants With Nonsense Mutation Aniridia

clinicaltrials.gov/study/NCT04117880

Is a

‌

Clinical study

Clinical Study attributes

NCT Number

NCT041178800

Health Conditions in Trial

Aniridia

Trial Recruitment Size

Trial Sponsor

PTC Therapeutics

Clinical Trial Start Date

December 31, 2018

Primary Completion Date

January 31, 2021

Study Completion Date

January 31, 2021

Clinical Trial Study Type

Interventional0

Interventional Trial Purpose

Treatment0

Intervention Type

Drug0

Intervention Name

Ataluren0

Interventional Trial Phase

Phase 20

Official Name

Nonsense Mutation Aniridia: An Ataluren (PTC124) Phase 2 Extension Study0

Last Updated

October 7, 2019

Allocation Type

NA0

Intervention Model

Single Group Assignment0

Masking Type

None (Open Label)0

Study summary

This is a Phase 2, multicenter, open-label study evaluating the overall systemic and ocular safety profile of ataluren in nonsense mutation aniridia as determined by the incidences of treatment-emergent adverse events (TEAEs) as well as abnormal findings on laboratory assessments, vital signs, physical examinations, ophthalmoscopy, and slit-lamp examination. Participants who complete PTC124-GD-028 ANI (NCT02647359) meet all inclusion and none of the exclusion criteria will be enrolled into this study.

Timeline

No Timeline data yet.

Further Resources

Title

Author

Link

Type

Date

No Further Resources data yet.

A Phase 2 Open Label Extension Study in Participants With Nonsense Mutation Aniridia

Contents

Clinical Study attributes

Timeline

Further Resources

References

Find more entities like A Phase 2 Open Label Extension Study in Participants With Nonsense Mutation Aniridia