Ligneous ConjunctivitisNCT04586062
Sponsor Initiated Expanded Access Protocol, Intermediate-Size Patient Population
A study testing Plasminogen in people with Ligneous Conjunctivitis, run by Kedrion S.p.A..
Trial summary
The purpose of this protocol is to provide compassionate use of Kedrion Human Plasminogen Ophthalmologic Drops to an expanded population of patients diagnosed with ligneous conjunctivitis associated with type I Plasminogen deficiency until product licensure, and/or until a new clinical trial is available and the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ligneous Conjunctivitis
- What is being tested?
- Plasminogen
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Subjects diagnosed with LC associated with Type I plasminogen deficiency, confirmed by laboratory documentation at screening visit, with or without ocular pseudomembranes. The presence of membranes in different areas is not an exclusion criterion.
- Subjects and their legally authorized representative, in the case of subjects <18 years of age, should be informed of the nature of the treatment, agree to its provision, sign and date the informed and data handling consent forms approved by the IRB.
- Subjects must be available for the duration of the treatment and agree to be compliant with the protocol visit and follow-up schedule.
- Subjects agree to keep the treating physician or specialist in charge informed about any occurrence related to the treatment.
Who cannot join
- Subjects with any condition which, in the opinion of the treating physician or specialist in charge might interfere with the treatment.
- Females of childbearing potential who are either pregnant or not using an adequate method of birth control (adequate is defined as hormonal contraceptive or partner vasectomy for at least 3 months, condoms, intrauterine device [IUD], abstinence or other prescribed birth control). Enrolled males must agree to utilize appropriate contraceptive methods to prevent pregnancy in partners.
- Females who are breastfeeding.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this protocol is to provide compassionate use of Kedrion Human Plasminogen Ophthalmologic Drops to an expanded population of patients diagnosed with ligneous conjunctivitis associated with type I Plasminogen deficiency until product licensure, and/or until a new clinical trial is available and the patients in treatment under Expanded Access are eligible to participate in the new trial.
- Conditions
- Ligneous Conjunctivitis
- Being tested
- Plasminogen
- Medical subject headings
- Plasminogen Deficiency, Type I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasminogenDrug
Human Plasminogen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ligneous ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Kedrion S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586062
- Sponsor's protocol ID
- SIEA-PLG
- Status last verified
- Oct 2023
- First submitted
- 6 Oct 2020
- Last updated
- 5 Oct 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sponsor Initiated Expanded Access Protocol, Intermediate-Size Patient Population
- ClinicalTrials.gov ID
- NCT04586062
- Acronym / sponsor ID
- SIEA-PLG
- Conditions
- Ligneous Conjunctivitis
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Kedrion S.p.A.Industry (pharma, biotech, devices)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this protocol is to provide compassionate use of Kedrion Human Plasminogen Ophthalmologic Drops to an expanded population of patients diagnosed with ligneous conjunctivitis associated with type I Plasminogen deficiency until product licensure, and/or until a new clinical trial is available and the patients in treatment under Expanded Access are eligible to participate in the new trial.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects diagnosed with LC associated with Type I plasminogen deficiency, confirmed by laboratory documentation at screening visit, with or without ocular pseudomembranes. The presence of membranes in different areas is not an exclusion criterion.
- Subjects and their legally authorized representative, in the case of subjects <18 years of age, should be informed of the nature of the treatment, agree to its provision, sign and date the informed and data handling consent forms approved by the IRB.
- Subjects must be available for the duration of the treatment and agree to be compliant with the protocol visit and follow-up schedule.
- Subjects agree to keep the treating physician or specialist in charge informed about any occurrence related to the treatment.
Key exclusion criteria (3 listed)
- Subjects with any condition which, in the opinion of the treating physician or specialist in charge might interfere with the treatment.
- Females of childbearing potential who are either pregnant or not using an adequate method of birth control (adequate is defined as hormonal contraceptive or partner vasectomy for at least 3 months, condoms, intrauterine device [IUD], abstinence or other prescribed birth control). Enrolled males must agree to utilize appropriate contraceptive methods to prevent pregnancy in partners.
- Females who are breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlasminogenHuman Plasminogen | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
Related trials for Ligneous Conjunctivitis
Enrolling by invitationPhase 3
Allogenic Plasma Aliquots in the Treatment of Ligneous Conjunctivitis
Ligneous Conjunctivitis, Left Eye
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Plasminogen in people with Ligneous Conjunctivitis, run by Kedrion S.p.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Lotti Suffredini (00390583767324, a.lotti@kedrion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.