Sponsor Initiated Expanded Access Protocol, Intermediate-Size Patient Population

NCT04586062 | Unknown

• 1 other identifier: SIEA-PLG
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ligneous Conjunctivitis

Interventions

Plasminogen DRUG

Human Plasminogen

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kedrion S.p.A.: lead

MeSH Terms

Conditions

Plasminogen Deficiency, Type I

Interventions

Plasminogen

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Beta-Globulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Protein Precursors

Central Study Contacts

Anna Lotti Suffredini

CONTACT

00390583767324; a.lotti@kedrion.com

Laura Pino

CONTACT

00390583767310; l.pino@kedrion.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Last Updated: October 5, 2023

Record last verified: 2023-10