ClinicalTrials.gg
AvailableNCT04586062Updated Oct 5, 2023

Sponsor Initiated Expanded Access Protocol, Intermediate-Size Patient Population

An expanded access record providing Plasminogen in Ligneous Conjunctivitis, sponsored by Kedrion S.p.A.. Available. Per ClinicalTrials.gov, last updated 2023-10-05.

Sponsored by Kedrion S.p.A. · Expanded access

Study type
Expanded access
Access type
Intermediate-size population
Sex
All
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Study summary

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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Conditions studied

  • Ligneous Conjunctivitis
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In context

Lead sponsor

Kedrion S.p.A. is the lead sponsor of 10 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 who are either pregnant or not using an adequate method of (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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

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Access details

Study type
Expanded access
Access type
Intermediate-size population

Available treatment

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Where to request access

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04586062
Lead sponsor
Kedrion S.p.A.
Responsible party
Sponsor
First posted
Oct 14, 2020
Last update
Oct 5, 2023

Study contacts

Anna Lotti Suffredini
Contact
a.lotti@kedrion.com
00390583767324
Laura Pino
Contact
l.pino@kedrion.com
00390583767310
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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