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NCT01554956 · ClinicalTrials.gov registry record · Phase 2
Efficacy/Safety of Human Plasminogen Eye Drop in Ligneous Conjunctivitis Patients
A Phase 2 study, sponsored by Kedrion S.p.A..
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01554956 is a Phase 2 study that has completed, run by Kedrion S.p.A.. The registered enrollment target is 12 participants.
The verdict
NCT01554956, a Phase 2 study, has completed, sponsored by Kedrion S.p.A..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
Kedrion Human Plasminogen, a sterile human plasma-derived plasminogen preparation for topical ocular use will be evaluated for the indication of treatment of ligneous conjunctivitis. KB046 will be an open-label, historically controlled clinical trial. At least 10 subjects with ligneous conjunctivitis, for approximately 20 eyes, will be treated and assessed. All subjects will receive the investigational medicinal product (IMP) for 12 to 48 weeks, with a possibility for extended treatment (Continuation segment)
Interventions
- BIOLOGICAL Human Plasminogen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-05-22 |
| Est. Completion | 2020-12-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01554956
The ClinicalTrials.gov registry entry for NCT01554956 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kedrion S.p.A., which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Human Plasminogen is the first listed.
NCT01554956 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01554956 about?
NCT01554956 is a clinical study titled "Efficacy/Safety of Human Plasminogen Eye Drop in Ligneous Conjunctivitis Patients". Kedrion Human Plasminogen, a sterile human plasma-derived plasminogen preparation for topical ocular use will be evaluated for the indication of treatment of ligneous conjunctivitis. KB046 will be an open-label, historically controlled clinical trial. At least 10 subjects with ligneous conjunctivit...
What is the current status of trial NCT01554956?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2013-05-22. Estimated completion is 2020-12-04.
What interventions are being tested in trial NCT01554956?
The interventions under investigation include: Human Plasminogen (BIOLOGICAL).
Who is sponsoring clinical trial NCT01554956?
This trial is sponsored by Kedrion S.p.A., which has 8 total clinical trials registered on ClinicalTrials.gov.
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