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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Kedrion S.p.A.
Sponsor:
Information provided by (Responsible Party):
Kedrion S.p.A.
ClinicalTrials.gov Identifier:
NCT01554956
First received: December 20, 2011
Last updated: May 15, 2013
Last verified: May 2013
  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.

KB-046 will be an open-label, historically controlled clinical trial. An estimated 10 subjects with ligneous conjunctivitis, with up to 20 affected eyes, will be treated and assessed. All 10 subjects will receive the investigational medicinal product (IMP) for 12 to 26 weeks, with a possibility for extended treatment.


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: 10
Study Start Date: September 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Human Plasminogen
    Eye Drops
  Eligibility

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 record or knowledge of lifetime disease course, including age of LC onset, history of pseudomembrane lesions, disease duration, past treatment for LC, response to treatment (including regression and recurrence) available for at least 6 months before study entrance.
  • 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.

Exclusion Criteria:

  • Subjects presenting ligneous conjunctivitis not associated with Type 1 plasminogen deficiency.
  • 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
  • Females who are breastfeeding.
  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

Contacts
Contact: Manuela Scarpellini +39 0583 19696 02 m.scarpellini@kedrion.com
Contact: Erin Farris 540-849-7774 efarris@atlanticresearchgroup.com

Locations
United States, California
University of California, San Francisco Not yet recruiting
San Francisco, California, United States, 94143
Contact: Bennie Jeng    415-206-8304    jengb@vision.ucsf.edu   
Contact: Cissy Yang    415 206-3123    yangc@vision.ucsf.edu   
Principal Investigator: Bennie H. Jeng, MD         
United States, Indiana
Indiana Hemophilia & Thrombosis Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Amy Shapiro, MD    317-871-0011    ashapiro@ihtc.org   
Contact: Neelam Thukral, CCRC    (317) 871-0011 ext 373    nthukral@ihtc.org   
Principal Investigator: Amy Shapiro, MD         
Italy
Meyer Children's Hospital Not yet recruiting
Florence, Italy
Contact: Roberto Caputo, MD    +39 0583 23742    r.caputo@meyer.it   
Contact: Neri Pucci, MD    338 8954279    n.pucci@meyer.it   
Principal Investigator: Roberto Caputo, MD         
Sub-Investigator: Cinzia de Libero, MD         
Sub-Investigator: Giacomo Maria Bacci, MD         
Sub-Investigator: Neri Pucci, MD         
Sponsors and Collaborators
Kedrion S.p.A.
  More Information

No publications provided

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: May 15, 2013
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
Tetrahydrozoline
Ophthalmic Solutions
Plasminogen
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Agents

ClinicalTrials.gov processed this record on August 18, 2014