Long-term Follow-up Study of Patients Who Received EG110A, a Non-replicative Herpes Simplex Virus 1-derived Gene Therapy

NCT ID: NCT07227285

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-30
• Study Completion Date: 2031-04-30

Brief Summary

The aim of this study is to continue following participants who have received EG110A during five years to know how it is tolerated in humans, any side-effects it may cause and what might be an effective dose over five years. All participants who have received at least one dose/injection of EG110A in a previous clinical study of EG110A will be asked to roll-over to this long-term follow-up study upon either early discontinuation from, or completion of, that study.

Detailed Description

The objective of this long-term follow-up study is to continue following participants who have received EG110A for safety, and to observe long-term efficacy via a disease-specific quality of life questionnaire, time to participant request for alternative treatment, and locally-evaluated urodynamics.

This study aims to identify any potential long-term risks and will capture any delayed adverse events (AEs) in participants following the last study visit of the preceding study. Additionally, it will allow the Sponsor to further understand the long-term effectiveness of EG110A in this patient population.

Conditions

Urinary Bladder, Overactive; Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients who received EG110A in a clinical study, regardless of dose

Group Type: EXPERIMENTAL

Urodynamics

Intervention Type: OTHER

standardized local evaluation of urodynamic parameters

EG110A

Intervention Type: DRUG

Patients already treated with EG110A

Patient-reported Outcome

Intervention Type: OTHER

assessment of participant's perception of the level of impairment in functioning and well-being associated with NDO symptoms

Interventions

Urodynamics

standardized local evaluation of urodynamic parameters

Intervention Type: OTHER

EG110A

Patients already treated with EG110A

Intervention Type: DRUG

Patient-reported Outcome

assessment of participant's perception of the level of impairment in functioning and well-being associated with NDO symptoms

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All participants who received at least one dose/injection of EG110A in Study EG110A-001-01 and have prematurely discontinued or completed that study.

Exclusion Criteria

• Participant plans to participate in another investigational gene therapy study
• Participant has an uncontrolled intercurrent illness, any disorder, or current substance abuse that would limit compliance with study requirements in the opinion of the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EG 427

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cornelia Haag-Molkenteller, MD

Role: STUDY_DIRECTOR

EG 427

Locations

Rancho Los Amigos National Rehabilitation Center

Downey, California, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Sidney Kimmel Medical College

Philadelphia, Pennsylvania, United States

UTHealth Houston / TIRR Memorial Hermann

Houston, Texas, United States

Countries

United States

Central Contacts

Sandrine Zourbas, Ph.D.

Role: CONTACT

szourbas@eg427.com

33 (0)625622802

Cornelia Haag-Molkenteller, MD

Role: CONTACT

Cornelia@eg427.com

Facility Contacts

Evgeniy Kreydin, MD

Role: primary

John Stoffel, MD

Role: primary

Patrick Shenot, MD

Role: primary

Argyrios Stampas, MD

Role: primary

Other Identifiers

EG110A-001-02

Identifier Type: -

Identifier Source: org_study_id