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

ConditionsUrinary Bladder, OveractiveSpinal Cord Injury
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEG 427

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Urodynamics

    Other intervention

    standardized local evaluation of urodynamic parameters

  • EG110A

    Drug

    Patients already treated with EG110A

  • Patient-reported Outcome

    Other intervention

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

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: Patients who received EG110A in a clinical study, regardless of doseExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of treatment emergent serious adverse events (TESAEs)

Any participant who has a reported treatment emergent serious adverse event (TESAE)

Time frame
5 years
2

Incidence of treatment emergent adverse events (TEAEs) including treatment emergent averse events of special interest (TEAESIs)

Any participant who has a reported emergent adverse event (TEAE) including treatment emergent averse events of special interest (TEAESIs)

Time frame
5 years

Secondary outcomes

1

Patient-reported outcome (PRO) questionnaire

Participantes I-QOL total summary scores throughout the study compared with baseline from EG110A-001-01 study

Time frame
5 years
2

Duration of response to EG110A

Time from initial treatment with EG110A to request an alternative treatment for NDO by the participant at any time during the long-term follow-up study

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EG 427

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: