Trials / Terminated
TerminatedNCT06495307
RHPRG4 FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)
A PHASE I PROSPECTIVE OPEN LABEL STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Lubris Bio Pty Ltd · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
rhPRG4-GVHD-001 is a prospective multi-center study conducted in Australia to evaluate the safety and efficacy of topically-applied rhPRG4 in subjects with moderate to severe dry eye secondary to chronic GVHD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rhPRG4 | Sterile isotonic aqueous solution containing rhPRG4 (450 µg/mL) for topical administration, 10 mM sodium phosphate, 150 mM sodium chloride \& 0.01% polysorbate 20 at pH 7.2. In all subjects, both eyes will be treated |
Timeline
- Start date
- 2025-02-14
- Primary completion
- 2025-03-22
- Completion
- 2025-03-22
- First posted
- 2024-07-10
- Last updated
- 2026-01-21
Locations
2 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT06495307. Inclusion in this directory is not an endorsement.