HypoplasminogenemiaNCT03265171
A Single-patient Study of Repeat-dose Administration of Prometic Plasminogen (Human) Intravenous
A study testing Plasminogen (Human) in people with Hypoplasminogenemia, run by Prometic Biotherapeutics, Inc..
Trial summary
These are single-patient studies with repeat-dose administration of ProMetic Plasminogen IV infusion in one adult and one child with hypoplasminogenemia. These patients are under treatment to address wound healing and obstructions. Read more about this study
- Who is it for?
- Ages 16 months and older
- Conditions the study is for
- Hypoplasminogenemia
- What is being tested?
- Plasminogen (Human)
- 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 16 months and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patient has provided informed consent.
- Patient has a diagnosis of compound homozygous Type 1 plasminogen deficiency as evidence by ligneous conjunctivitis since birth as well as involvement of the conjunctiva, nasopharynx, gingiva, tracheobronchial tree, gastrointestinal tract, and urinary tract.
Who cannot join
- Not applicable
About this study
Official title: A Single-patient Study of Repeat-dose Administration of ProMetic Plasminogen (Human) Intravenous Infusion in an Adult With Hypoplasminogenemia
These are single-patient studies with repeat-dose administration of ProMetic Plasminogen IV infusion in one adult and one child with hypoplasminogenemia. These patients are under treatment to address wound healing and obstructions.
- Conditions
- Hypoplasminogenemia
- Being tested
- Plasminogen (Human)
- Medical subject headings
- Congenital Plasminogen Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasminogen (Human)Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoplasminogenemiaStudies 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
- Prometic Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cedars-Sinai Medical Center, Vanderbilt University Medical Center, Indiana Hemophilia &Thrombosis Center, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265171
- Sponsor's protocol ID
- 2002C013G
- Status last verified
- Apr 2020
- First submitted
- 25 Aug 2017
- Last updated
- 24 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-patient Study of Repeat-dose Administration of ProMetic Plasminogen (Human) Intravenous Infusion in an Adult With Hypoplasminogenemia
- ClinicalTrials.gov ID
- NCT03265171
- Acronym / sponsor ID
- 2002C013G
- Conditions
- Hypoplasminogenemia
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Prometic Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cedars-Sinai Medical Center, Vanderbilt University Medical Center, Indiana Hemophilia &Thrombosis Center, Inc.
- First posted
- 29 Aug 2017 (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.
These are single-patient studies with repeat-dose administration of ProMetic Plasminogen IV infusion in one adult and one child with hypoplasminogenemia. These patients are under treatment to address wound healing and obstructions.
Study design
Who may qualify
- Ages
- 16 months and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient has provided informed consent.
- Patient has a diagnosis of compound homozygous Type 1 plasminogen deficiency as evidence by ligneous conjunctivitis since birth as well as involvement of the conjunctiva, nasopharynx, gingiva, tracheobronchial tree, gastrointestinal tract, and urinary tract.
Key exclusion criteria (1 listed)
- Not applicable
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 |
|---|---|---|
| Plasminogen (Human) | Biological | – |
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 24 Apr 2020.
Related trials for Hypoplasminogenemia
RecruitingObservational study
Study of Individuals Affected With Hypoplasminogenemia
Plasminogen Deficiency
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Plasminogen (Human) in people with Hypoplasminogenemia, run by Prometic Biotherapeutics, Inc..
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 2 inclusion and 1 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 24 Apr 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 24 Apr 2020.