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Clinical Trials in the USA / NCT05613569
Active, not recruiting Observational

A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study

NCT05613569 · tracked via the Priya Life Science USA tracker
Sponsor
Kolon Life Science
Phase
Observational
Started
2022-07-26
Last updated
2024-07-08

Condition(s) studied

Lumbosacral Radiculopathy

Investigational drug(s) / intervention(s)

KLS-2031

KLS-2031: KLS-2031 administered by transforaminal epidural injection

Study summary

This is a long-term, 3-year, follow-up study for patients completing the KS-GIG-001-01 Study

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria : To be considered eligible to participate in this study, a patient must meet the inclusion criteria listed below: 1. Patients that have completed the KS-GIG-001-01 Study and were in the Active Treatment group 2. Patients having signed the consent forms for both the KS-GIG-001-01 Study and this Long Term, 3-Year Follow-up Study Exclusion Criteria : To be eligible for entry into the study, the patient must not meet any of the exclusion criteria listed below: 1\. Enrollment in another AAV or other gene therapy trial

Primary outcome measure(s)

  • Long-term safety of KLS-2031 as assessed by frequency and nature of AEs, laboratory test results, vital sign measurements, physical and complete neurological examinations, and 12 lead ECGs through 156 weeks. — Baseline through the end of study (approximately 3 years)
    Long-term safety of KLS-2031 as assessed by frequency and nature of AEs, laboratory test results, vital sign measurements, physical and complete neurological examinations, and 12 lead ECGs through 156 weeks.

Trial sites (1)

FacilityCityRegionStatus
Kolon Investigative Site : CenExel JBR Salt Lake City Utah

Other trials for the same condition

Efficacy and Safety of VER-01 in the Treatment of Participants With Chronic Painful Lumbosacral Radiculopathy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05613569 on ClinicalTrials.gov ↗ ← All trials in the USA