Sponsor Initiated Expanded Access Protocol, Intermediate-Size Patient Population

Kedrion Biopharma

Status

Conditions: Ligneous Conjunctivitis

Treatments: Drug: Plasminogen

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT04586062

SIEA-PLG

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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.