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Trial record 1 of 1 for:    NCT01554956
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Efficacy/Safety of Human Plasminogen Eye Drop in Ligneous Conjunctivitis Patients

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ClinicalTrials.gov Identifier: NCT01554956
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : February 18, 2021
Information provided by (Responsible Party):
Kedrion S.p.A.

Brief Summary:

Kedrion Human Plasminogen, a sterile human plasma-derived plasminogen preparation for topical ocular use will be evaluated for the indication of treatment of ligneous conjunctivitis.

KB046 will be an open-label, historically controlled clinical trial. At least 10 subjects with ligneous conjunctivitis, for approximately 20 eyes, will be treated and assessed. All subjects will receive the investigational medicinal product (IMP) for 12 to 48 weeks, with a possibility for extended treatment (Continuation segment)

Condition or disease Intervention/treatment Phase
Ligneous Conjunctivitis Biological: Human Plasminogen Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Historically Controlled Phase II/III Study to Evaluate Efficacy and Safety of Kedrion Human Plasminogen Eye Drop Preparation in Patients Diagnosed With Ligneous Conjunctivitis
Actual Study Start Date : May 22, 2013
Actual Primary Completion Date : April 25, 2014
Actual Study Completion Date : December 4, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pink Eye
Drug Information available for: Plasminogen

Arm Intervention/treatment
Experimental: Human Plasminogen
Human Plasminogen Eye Drop treatment
Biological: Human Plasminogen
Eye Drops

Primary Outcome Measures :
  1. Number of eyes with recurrent ligneous membranes after initially showing total regression after treatment or after surgical excision. [ Time Frame: 12 weeks ]
  2. Number of eyes with reduction of overall membrane surface area assessed by measurement of scaled photographs at study start and at the end of each 4 week cycle. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Number of subjects who experience adverse events. [ Time Frame: Up to 26 weeks. ]
  2. Number of subjects who develop antibodies against human plasminogen. [ Time Frame: Up to 26 weeks. ]
  3. Number of subjects who develop antibodies against bovine aprotinin. [ Time Frame: Up to 26 weeks. ]
  4. Number of subjects who experience signs and symptoms of sensitization. [ Time Frame: Up to 26 weeks. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects should be diagnosed with ligneous conjunctivitis associated with Type I plasminogen deficiency, confirmed by the central laboratory and documented at pre-enrollment screening. The concomitant presence of other ligneous pseudomembranes at different sites will not constitute an exclusion criterion.
  • Subjects should have documented historical records of disease course available for a period of at least 6 months surrounding an episode of LC, even if asymptomatic in the past for a newly diagnosed subject , including but not limited to age of LC onset, diagnosis of Plasminogen 1 deficiency, history of pseudomembrane lesions, disease duration, past treatment for LC, response to treatment and/or surgery (including regression and recurrence), before study entrance. If more history than 6 months surrounding an LC episode is available it will be included.
  • Subjects, or their legally authorized representative, in the case of study participants < 18 years of age, should have been informed of the nature of the study, agreed to its provision, signed and dated the informed consent approved by the investigational review board (IRB) or ethics committee (EC).
  • Subjects available for the duration of the study will be included. The Investigator will make sure that there is no plan for the subject to leave the area of the study site before the end of the study period. If they come from another center, they must agree to be compliant with the protocol mandated study visits and return for follow-up.

Exclusion Criteria:

  • Subjects presenting ligneous conjunctivitis not associated with Type 1 plasminogen deficiency.
  • Subjects with no history of LC lesions for Group 2, for Group 1 the entry lesions could be the first and included as history.
  • Subject presenting antibodies against plasminogen at screening.
  • Subjects with any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives, or participation in this trial.
  • Subjects unwilling to give written informed consent or assent to participation.
  • Subjects who have participated in another clinical trial within 1 month before study initiation, i.e. they have received any test drug within 30 days prior the study.
  • Females of childbearing potential who are either pregnant or not using an adequate method of birth control
  • Females who are breastfeeding.
  • Subjects being treated with FFP or Laboratory Grade Plasminogen will undergo a washout period of at least 15 days before being considered for this study. This information will be disseminated to subjects ahead of their Screening Visit and will only occur following signing of the Informed Consent

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): NCT01554956

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United States, Indiana
Indiana Hemophilia & Thrombosis Center
Indianapolis, Indiana, United States, 46260
Meyer Children's Hospital
Florence, Italy
AOU Padova
Padova, Italy
Sponsors and Collaborators
Kedrion S.p.A.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kedrion S.p.A.
ClinicalTrials.gov Identifier: NCT01554956    
Other Study ID Numbers: KB046
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 2021
Keywords provided by Kedrion S.p.A.:
Plasminogen Deficiency
Ligneous Conjunctivitis
Ligneous Conjunctivitis in Plasminogen Deficient Patients
Additional relevant MeSH terms:
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Skin Diseases, Genetic
Conjunctival Diseases
Eye Diseases
Genetic Diseases, Inborn
Skin Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action