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Sponsor Initiated Expanded Ac...

Sponsor Initiated Expanded Access Protocol, Intermediate-Size Patient Population

Last Updated: 2023-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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The purpose of this protocol is to provide compassionate use of Kedrion Human Plasminogen Ophthalmologic Drops to an expanded population of patients diagnosed with ligneous conjunctivitis associated with type I Plasminogen deficiency until product licensure, and/or until a new clinical trial is available and the patients in treatment under Expanded Access are eligible to participate in the new trial.

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Detailed Description

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Conditions

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Ligneous Conjunctivitis

Interventions

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Plasminogen

Human Plasminogen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects diagnosed with LC associated with Type I plasminogen deficiency, confirmed by laboratory documentation at screening visit, with or without ocular pseudomembranes. The presence of membranes in different areas is not an exclusion criterion.
* Subjects and their legally authorized representative, in the case of subjects \<18 years of age, should be informed of the nature of the treatment, agree to its provision, sign and date the informed and data handling consent forms approved by the IRB.
* Subjects must be available for the duration of the treatment and agree to be compliant with the protocol visit and follow-up schedule.
* Subjects agree to keep the treating physician or specialist in charge informed about any occurrence related to the treatment.

Exclusion Criteria

* Subjects with any condition which, in the opinion of the treating physician or specialist in charge might interfere with the treatment.
* Females of childbearing potential who are either pregnant or not using an adequate method of birth control (adequate is defined as hormonal contraceptive or partner vasectomy for at least 3 months, condoms, intrauterine device \[IUD\], abstinence or other prescribed birth control). Enrolled males must agree to utilize appropriate contraceptive methods to prevent pregnancy in partners.
* Females who are breastfeeding.

Eligible Sex

ALL

Accepts Healthy Volunteers