Clinical Trials in South Korea / NCT07629115
Recruiting
Observational
A Long-Term Follow-up Study of the Severe Parkinson's Disease Patients Administered the IPS101A Gene Therapy Product.
NCT07629115 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Parkinson DiseaseParkinson's Disease
Study summary
The purpose of this study is to evaluate the long-term safety of IPS101A and to assess the durability of efficacy in subjects who received IPS101A.
Eligibility
Inclusion Criteria
* Subjects who were enrolled in the IPS101A-10 clinical trial and received IPS101A.
* Subjects and/or their legally acceptable representatives who voluntarily provided written informed consent to participate in this long-term follow-up study after being fully informed of the study, and who agreed to comply with all study-related requirements.
Exclusion Criteria
* Subjects who decline to provide consent for participation in the long-term follow-up study, or for whom follow-up assessments are not feasible due to death or other reasons.
* Subjects who, in the judgment of the investigator, are considered unsuitable for participation in the study due to unwillingness or inability to comply with scheduled study visits or other study-related requirements.
Primary outcome measure(s)
- Safety Evaluation: Incidence of serious adverse events of special interest — Baseline to 5 years
Assess severity and frequency serious adverse events of special interest - Safety Evaluation: Incidence of serious adverse events (SAEs) and adverse events (AEs) — Baseline to 5 years
Assess severity and frequency of reported adverse events - Safety Evaluation: Number of participants with clinically-relevant changes in physical exams — Baseline to 5 years
The results of the physical examination after administration of the clinical trial drug are compared with those before administration to determine whether clinically significant symptoms occur - Safety Evaluation: Number of participants with clinically-relevant changes in laboratory test — Baseline to 5 years
The clinical significance of laboratory test results after administration of a clinical trial drug is confirmed by comparing them with those before administration.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Severance Hospital | Seoul | South Korea | Recruiting |
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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 NCT07629115 on ClinicalTrials.gov ↗ ← All trials in South Korea