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NCT03203330 · ClinicalTrials.gov registry record · Phase 3
A Study to Determine the Safety and Efficacy of TG-C in Subjects With Kellgren and Lawrence Grade 2 or 3 OA of the Knee
A Phase 3 study of Degenerative Osteoarthritis, sponsored by Kolon TissueGene.
- Active
- Registry status
- Phase 3
- Development phase
- 535
- Enrollment target
- 20
- Study locations
NCT03203330 is a Phase 3 study of Degenerative Osteoarthritis that is active but no longer recruiting, run by Kolon TissueGene. The registered enrollment target is 535 participants. The trial reports 20 study locations across 5 states.
The verdict
NCT03203330, a Phase 3 study of Degenerative Osteoarthritis, is active but no longer recruiting, sponsored by Kolon TissueGene.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 535 participants
- Enrollment target
- 20
- Study locations
Study Summary
A randomized, double-blind, placebo-controlled, multi-center, phase 3 study to determine the safety and efficacy of TG-C in subjects with Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee, Osteoarthritis Research Society International (OARSI) medial joint space narrowing (JSN) Grade 1 or 2 of the knee joint. TG-C is to be administered by a single intra-articular injection to the damaged joint area via ultrasound guidance. Patients will be followed for 24 months for safety and efficacy.
Conditions Studied
Interventions
- BIOLOGICAL TG-C
- BIOLOGICAL Placebo Control
Study Locations (20)
Florida
- David Billmeier - Daytona Beach
- Mercedes Ponce De Leon - Miami
- Aurelio Torres-Consuegra - Miami
- Edgar Gonzalez - Miami
- Cathy Barnes - New Port Richey
- Howard Chipman - Oldsmar
- Richard Linn - Sunrise
- Anand Patel - Winter Park
California
- Diraj Karnani - Apple Valley
- Dan La - Covina
- Scott Hacker - La Mesa
- Eric Grigsby - Napa
- Arthur Mabaquiao - San Diego
- Timothy Davis - Santa Monica
- Tien-I Su - Whittier
Alabama
- Jeffrey Davis - Birmingham
- Bradly Goodman - Birmingham
Arizona
- Saima Chohan - Phoenix
- Nebojsa Skrepnik - Tucson
District of Columbia
- Mehul Desai - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 535 participants |
| Start Date | 2018-10-30 |
| Est. Completion | 2026-07-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03203330
The ClinicalTrials.gov registry entry for NCT03203330 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 535 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kolon TissueGene, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Degenerative Osteoarthritis appearing as the primary indexed condition, and to 2 interventions - of which TG-C is the first listed.
NCT03203330 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT03203330 about?
NCT03203330 is a clinical study titled "A Study to Determine the Safety and Efficacy of TG-C in Subjects With Kellgren and Lawrence Grade 2 or 3 OA of the Knee". A randomized, double-blind, placebo-controlled, multi-center, phase 3 study to determine the safety and efficacy of TG-C in subjects with Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee, Osteoarthritis Research Society International (OARSI) medial joint space narrowing (JSN) Grade 1 or...
What is the current status of trial NCT03203330?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 535 participants. The study started on 2018-10-30. Estimated completion is 2026-07-10.
What conditions does trial NCT03203330 study?
This clinical trial studies the following conditions: Degenerative Osteoarthritis.
What interventions are being tested in trial NCT03203330?
The interventions under investigation include: TG-C (BIOLOGICAL), Placebo Control (BIOLOGICAL).
Who is sponsoring clinical trial NCT03203330?
This trial is sponsored by Kolon TissueGene, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03203330 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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