Active — Not RecruitingNot Applicable

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

United States5 participantsStarted 2022-07-26

Plain-language summary

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

Who can participate

SexALL

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Inclusion criteria

✓. Patients that have completed the KS-GIG-001-01 Study and were in the Active Treatment group
✓. Patients having signed the consent forms for both the KS-GIG-001-01 Study and this Long Term, 3-Year Follow-up Study

What they're measuring

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.

Timeframe: Baseline through the end of study (approximately 3 years)

Trial details

NCT IDNCT05613569

SponsorKolon Life Science

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-08-30

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