Efficacy/Safety of Human Plasminogen Eye Drop in Ligneous Conjunctivitis Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/28/2016 |
| Start Date: | September 2012 |
| End Date: | December 2017 |
A Historically Controlled Phase II/III Study to Evaluate Efficacy and Safety of Kedrion Human Plasminogen Eye Drop Preparation in Patients Diagnosed With Ligneous Conjunctivitis
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)
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)
Inclusion Criteria:
- Subjects should be diagnosed with ligneous conjunctivitis associated with Type I
plasminogen deficiency, confirmed by the central laboratory and documented at
pre-enrollment screening. The concomitant presence of other ligneous pseudomembranes
at different sites will not constitute an exclusion criterion.
- Subjects should have documented historical records of disease course available for a
period of at least 6 months surrounding an episode of LC, even if asymptomatic in the
past for a newly diagnosed subject , including but not limited to age of LC onset,
diagnosis of Plasminogen 1 deficiency, history of pseudomembrane lesions, disease
duration, past treatment for LC, response to treatment and/or surgery (including
regression and recurrence), before study entrance. If more history than 6 months
surrounding an LC episode is available it will be included.
- Subjects, or their legally authorized representative, in the case of study
participants < 18 years of age, should have been informed of the nature of the study,
agreed to its provision, signed and dated the informed consent approved by the
investigational review board (IRB) or ethics committee (EC).
- Subjects available for the duration of the study will be included. The Investigator
will make sure that there is no plan for the subject to leave the area of the study
site before the end of the study period. If they come from another center, they must
agree to be compliant with the protocol mandated study visits and return for
follow-up.
Exclusion Criteria:
- Subjects presenting ligneous conjunctivitis not associated with Type 1 plasminogen
deficiency.
- Subjects with no history of LC lesions for Group 2, for Group 1 the entry lesions
could be the first and included as history.
- Subject presenting antibodies against plasminogen at screening.
- Subjects with any condition which, in the opinion of the Investigator, might
interfere with the evaluation of the study objectives, or participation in this
trial.
- Subjects unwilling to give written informed consent or assent to participation.
- Subjects who have participated in another clinical trial within 1 month before study
initiation, i.e. they have received any test drug within 30 days prior the study.
- Females of childbearing potential who are either pregnant or not using an adequate
method of birth control
- Females who are breastfeeding.
- Subjects being treated with FFP or Laboratory Grade Plasminogen will undergo a
washout period of at least 15 days before being considered for this study. This
information will be disseminated to subjects ahead of their Screening Visit and will
only occur following signing of the Informed Consent
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