Trials Sponsors Conditions Drugs Pricing

Conditions

X-Linked Retinitis Pigmentosa (XLRP)

Keywords

X-Linked Retinitis Pigmentosa (XLRP)FT-002

Outcome Measures

Primary Outcomes (1)

To evaluate the safety and tolerance of FT-002
Incidence and severity of AEs
from FT-002 administration through up to 1 years

Secondary Outcomes (1)

To evaluate the efficacy of FT-002
from FT-002 administration through up to 1 years

Study Arms (2)

FT-002 dose 1

EXPERIMENTAL

Low dose FT-002

Genetic: FT-002

High dose FT-002

EXPERIMENTAL

High dose FT-002

Genetic: FT-002

Interventions

FT-002Genetic

Intraocular injection of a single dose

FT-002 dose 1High dose FT-002

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age8 Years - 45 Years

Sexmale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Subjects that are willing and able to follow study procedures including scheduled visits, treatment plan, and laboratory tests, and sign a written informed consent form;
Age: Phase I dose escalation stage, 18-45 years old male (including boundary value) at the time of signing the ICF; Phase II dose extension stage, males 8-45 years old (including boundary values) at the time of signing the ICF;

Sponsors & Collaborators

Frontera Therapeutics
Industrylead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Ruifang Sui, ProfessorCONTACT

Study Officials

Ruifang Sui
Peking Union Medical College Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinyan Li

CONTACT

+86-021-58206061 xinyan.li@fronteratherapeutics.com

Minghui Xue

CONTACT

+86-021-58206061

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 9, 2024

Study Start

April 1, 2024

Actual (reported)

Primary Completion

August 1, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Gene Therapy for RPGR Gene Mutation-associated X-linked Retinitis Pigmentosa

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

FT-002 dose 1

High dose FT-002

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

FT-002 dose 1

High dose FT-002

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations