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NCT04737720 · ClinicalTrials.gov registry record
Intravenous ACP-501 for Familial LCAT Deficiency (rhLCAT)
A clinical trial, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 1
- Enrollment target
NCT04737720: Completed study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT04737720 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04737720 has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 1 participants
- Enrollment target
Study Summary
Background: * High density lipoprotein (HDL), or good cholesterol, moves cholesterol from the artery walls back to the liver. A blood enzyme known as LCAT maintains HDL levels and helps it remove cholesterol from the body. Familial LCAT deficiency (FLD) is a genetic disease that results in low levels or total absence of LCAT. People with FLD often have kidney problems, and may develop kidney failure. Researchers think that the clinical problems of FLD can be prevented or even reversed by replacing the defective enzyme. * There are no drugs that increase LCAT. It has to be artificially made and infused into the body. The artificial LCAT is called recombinant human LCAT, or ACP-501. Researchers want to see how well it works in one person with FLD and poor kidney function. Objectives: \- To see whether ACP-501 can improve the symptoms of FLD. Eligibility: \- One person (the study participant) with FLD. Design: * The participant will be screened with a physical exam and medical history. Blood samples will be collected. * The participant will receive ACP-501 and remain in the hospital for 24 hours for regular blood tests. The participant may stay in the hospital or return for daily clinic visits until it is time for the next dose. The second dose will be given on Day 4 or Day 8. * If an optimal dose has not yet been identified, a third dose will be given 7 days after the second dose. * The participant will then go home, but must return to the hospital for ACP-501 infusions and blood tests every 1 or 2 weeks, as needed. Every 3 months, the participant will have a full clinic visit with blood tests and other studies.
Primary Outcome
Increased
Interventions
- DRUG Recombinant LCAT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2013-01-24 |
What the finished NCT04737720 record still lists
NCT04737720 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 1 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Recombinant LCAT is the first listed.
NCT04737720 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04737720 about?
NCT04737720 is a clinical study titled "Intravenous ACP-501 for Familial LCAT Deficiency (rhLCAT)". Background: * High density lipoprotein (HDL), or good cholesterol, moves cholesterol from the artery walls back to the liver. A blood enzyme known as LCAT maintains HDL levels and helps it remove cholesterol from the body. Familial LCAT deficiency (FLD) is a genetic disease that results in low leve...
What is the current status of trial NCT04737720?
This trial is currently completed. The enrollment target is 1 participants. The study started on 2013-01-24.
What interventions are being tested in trial NCT04737720?
The interventions under investigation include: Recombinant LCAT (DRUG).
Who is sponsoring clinical trial NCT04737720?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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