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UnknownNCT04475224

Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury

A Non-randomized, Multicenter, Confirmatory Study by Intrathecal Administration of KP-100IT in Subjects With Acute Spinal Cord Injury

Status
Unknown
Phase
Phase 3
Study type
Interventional
Enrollment
25 (estimated)
Sponsor
Kringle Pharma, Inc. · Industry
Sex
All
Age
18 Years – 89 Years
Healthy volunteers
Not accepted

Summary

This study is non-randomized, multicenter, confirmatory study by intrathecal administration of KP-100IT, code of HGF (Hepatocyte Growth Factor ) formulation for intrathecal injection, in subjects with acute spinal cord injury.

Conditions

Interventions

TypeNameDescription
DRUGKP-100ITIntrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times

Timeline

Start date
2020-07-13
Primary completion
2022-12-31
Completion
2023-06-30
First posted
2020-07-17
Last updated
2022-08-26

Locations

5 sites across 1 country: Japan

Source: ClinicalTrials.gov record NCT04475224. Inclusion in this directory is not an endorsement.

Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury (NCT04475224) · Clinical Trials Directory