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

NCT04475224 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-08-26

No results posted yet for this study

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

  • Acute Spinal Cord Injury

Interventions

DRUG

KP-100IT

Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times

Sponsors & Collaborators

  • Kringle Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Etsuro Hashimura · Kringle Pharma, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2022-12-31
Completion
2023-06-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04475224 on ClinicalTrials.gov