This trial is active, not recruiting.

Condition ligneous conjunctivitis
Treatment human plasminogen
Phase phase 2/phase 3
Sponsor Kedrion S.p.A.
Start date September 2012
End date April 2014
Trial size 12 participants
Trial identifier NCT01554956, KB046


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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Human Plasminogen Eye Drop treatment
human plasminogen
Eye Drops

Primary Outcomes

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

Secondary Outcomes

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.

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Kedrion S.p.A..