Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Kedrion S.p.A..
NCT01554956 is a Phase 2 study that has completed, run by Kedrion S.p.A.. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
The primary endpoint (prevention of pseudomembrane relapse) was presented descriptively based on the predefined success levels: complete success (defined as no relapse by the end of Segment 2), partial success(defined as relapse appearing 2 weeks or longer after the start of Segment 2, or if following the 3 rd cycle of Segment 2 for Group 1A no relapse occurred while maintaining the higher dose) or failure (defined as relapse within 2 weeks of the start of Segment 2 or if at repeat cycles of Seg
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 |
What the finished NCT01554956 record still lists
NCT01554956 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Human Plasminogen is the first listed.
NCT01554956 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01554956's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02602769 · 12 participants
Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome
- NCT02605421 · 12 participants · Phase 2
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
- NCT02619448 · 12 participants · Early Phase 1
Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC
- NCT03311503 · 12 participants · Phase 1
Phase I/II Trial of Lentiviral Gene Transfer for SCID-X1 With Low Dose Targeted Busulfan Conditioning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI