Efficacy/Safety of Human Plasminogen Eye Drop in Ligneous Conjunctivitis Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kedrion S.p.A.
ClinicalTrials.gov Identifier:
NCT01554956
First received: December 20, 2011
Last updated: July 26, 2016
Last verified: July 2016
  Purpose

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 Intervention Phase
Ligneous Conjunctivitis
Biological: Human Plasminogen
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Kedrion S.p.A.:

Primary Outcome Measures:
  • Number of eyes with recurrent ligneous membranes after initially showing total regression after treatment or after surgical excision. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of subjects who experience adverse events. [ Time Frame: Up to 26 weeks. ] [ Designated as safety issue: Yes ]
  • Number of subjects who develop antibodies against human plasminogen. [ Time Frame: Up to 26 weeks. ] [ Designated as safety issue: Yes ]
  • Number of subjects who develop antibodies against bovine aprotinin. [ Time Frame: Up to 26 weeks. ] [ Designated as safety issue: Yes ]
  • Number of subjects who experience signs and symptoms of sensitization. [ Time Frame: Up to 26 weeks. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: September 2012
Estimated Study Completion Date: December 2017
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Human Plasminogen
Human Plasminogen Eye Drop treatment
Biological: Human Plasminogen
Eye Drops

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554956

Locations
United States, Indiana
Indiana Hemophilia & Thrombosis Center
Indianapolis, Indiana, United States, 46260
Italy
Meyer Children's Hospital
Florence, Italy
AOU Padova
Padova, Italy
Sponsors and Collaborators
Kedrion S.p.A.
  More Information

Responsible Party: Kedrion S.p.A.
ClinicalTrials.gov Identifier: NCT01554956     History of Changes
Other Study ID Numbers: KB046 
Study First Received: December 20, 2011
Last Updated: July 26, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Kedrion S.p.A.:
Plasminogen Deficiency
Ligneous Conjunctivitis
Plasminogen
Ligneous Conjunctivitis in Plasminogen Deficient Patients

Additional relevant MeSH terms:
Conjunctivitis
Skin Diseases, Genetic
Conjunctival Diseases
Eye Diseases
Genetic Diseases, Inborn
Skin Diseases
Ophthalmic Solutions
Tetrahydrozoline
Plasminogen
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2016