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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01554956
Recruitment Status : Active, not recruiting
First Posted : March 15, 2012
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Kedrion S.p.A.

Tracking Information
First Submitted Date  ICMJE December 20, 2011
First Posted Date  ICMJE March 15, 2012
Last Update Posted Date February 6, 2020
Study Start Date  ICMJE September 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2012)
  • Number of eyes with recurrent ligneous membranes after initially showing total regression after treatment or after surgical excision. [ Time Frame: 12 weeks ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2012)
  • Number of subjects who experience adverse events. [ Time Frame: Up to 26 weeks. ]
  • Number of subjects who develop antibodies against human plasminogen. [ Time Frame: Up to 26 weeks. ]
  • Number of subjects who develop antibodies against bovine aprotinin. [ Time Frame: Up to 26 weeks. ]
  • Number of subjects who experience signs and symptoms of sensitization. [ Time Frame: Up to 26 weeks. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy/Safety of Human Plasminogen Eye Drop in Ligneous Conjunctivitis Patients
Official Title  ICMJE 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
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)

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ligneous Conjunctivitis
Intervention  ICMJE Biological: Human Plasminogen
Eye Drops
Study Arms  ICMJE Experimental: Human Plasminogen
Human Plasminogen Eye Drop treatment
Intervention: Biological: Human Plasminogen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 26, 2016)
12
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2012)
10
Estimated Study Completion Date  ICMJE March 2020
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01554956
Other Study ID Numbers  ICMJE KB046
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kedrion S.p.A.
Study Sponsor  ICMJE Kedrion S.p.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kedrion S.p.A.
Verification Date November 2019

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