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

December 20, 2011
May 15, 2013
September 2012
October 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01554956 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy/Safety of Human Plasminogen Eye Drop in Ligneous Conjunctivitis Patients
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ligneous Conjunctivitis
Biological: Human Plasminogen
Eye Drops
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
January 2015
October 2014   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact: Manuela Scarpellini +39 0583 19696 02 m.scarpellini@kedrion.com
Contact: Erin Farris 540-849-7774 efarris@atlanticresearchgroup.com
United States,   Italy
 
NCT01554956
KB046
No
Kedrion S.p.A.
Kedrion S.p.A.
Not Provided
Not Provided
Kedrion S.p.A.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP