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Allogenic Plasma Aliquots in the Treatment of Ligneous Conjunctivitis

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ClinicalTrials.gov Identifier: NCT04275232
Recruitment Status : Enrolling by invitation
First Posted : February 19, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Canadian Blood Services
Information provided by (Responsible Party):
Dorothy Bautista, MD, Memorial University of Newfoundland

Brief Summary:
Allogenic plasma aliquots, used as eye drops, will provide a source of plasminogen in the treatment of ligneous conjunctivitis. The investigational product will be available through written request from the Sponsor-Investigator to Canadian Blood Services, as approved by Health Canada.

Condition or disease Intervention/treatment Phase
Ligneous Conjunctivitis, Left Eye Biological: Allogenic plasma aliquots, a source of plasminogen Phase 3

Detailed Description:
Ligneous conjunctivitis is a chronic progressive disorder of the conjunctival mucosa which occurs secondary to plasminogen deficiency. The condition is characterized by thick, fibrous pseudo membranes adherent to the conjunctival surface of the eye lid.The investigational product, allogenic plasma aliquots, is a source of plasminogen. It will be used as eye drops, to treat recurrences of these pseudo membranes by providing the plasminogen required for fibrinolysis. The allogenic plasma aliquots are prepared by Canadian Blood Services. An initial supply of 680 vials was made available through the Special Access program, upon approval by Health Canada. Through this Clinical Trial, additional allogenic plasma aliquots will be available when required to treat recurrences of the pseudo membranes. The study has been conditionally approved by local HREB, pending registration with clinicaltrials.gov

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The patient will receive treatment with the interventional biologic product when she experiences recurrences of ligneous conjunctivitis
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Allogenic Plasma Aliquots as a Source of Plasminogen in the Treatment of Ligneous Conjunctivitis, Clinical Trial of One Case
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
Experimental: Allogenic Plasma Aliquots
Allogenic Plasma Aliquots to be used as eye drops in the treatment of recurrences of ligneous conjunctivitis. Two drops will be administered to the affected eye, every 1 to 4 hours, depending on severity of the recurrence.
Biological: Allogenic plasma aliquots, a source of plasminogen
Plasma eye drops, a source of plasminogen




Primary Outcome Measures :
  1. Resolution of pseudo membrane associated with ligneous conjunctivitis [ Time Frame: From date of first documented recurrence of pseudo membranes up to two years, starting from the date of enrolment ]
    Patient to be observed daily to every few weeks for resolution, based on clinical observation



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Clinical trial involves one patient (female)
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject diagnosed with ligneous conjunctivitis associated with Type 1 plasminogen deficiency

Exclusion Criteria:

  • Subject has concurrent eye disease which prevents use of the investigational drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04275232


Locations
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Canada, Newfoundland and Labrador
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Sponsors and Collaborators
Dorothy Bautista, MD
Canadian Blood Services
Investigators
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Principal Investigator: Dorothy V Bautista, MD Memorial University of Newfoundland
Publications:

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Responsible Party: Dorothy Bautista, MD, Clinical Professor, Memorial University of Newfoundland
ClinicalTrials.gov Identifier: NCT04275232    
Other Study ID Numbers: DVB-LC-1
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Conjunctivitis
Skin Diseases, Genetic
Conjunctival Diseases
Eye Diseases
Genetic Diseases, Inborn
Skin Diseases
Plasminogen
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action