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NCT04781309 · ClinicalTrials.gov registry record · Early Phase 1
NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Progressive Multifocal Leukoencephalopathy
A Early Phase 1 study of Progressive Multifocal Leukoencephalopathy, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04781309 is a Early Phase 1 study of Progressive Multifocal Leukoencephalopathy that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 12 participants, below the 255-participant average among 3 other Progressive Multifocal Leukoencephalopathy trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04781309, a Early Phase 1 study of Progressive Multifocal Leukoencephalopathy, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Progressive multifocal leukoencephalopathy (PML) is a brain infection. It is caused by a virus. PML can happen in people with a weakened immune system. PML is associated with cognitive and visual impairment as well as motor and speech disturbances. There is no treatment for PML. Researchers want to see if a new drug can help. Objective: To see if the drug NT-I7 can help increase lymphocyte numbers, which may help control PML infection. Eligibility: Adults ages 18 and older with PML who are enrolled in Protocol #13-N-0017. Design: Participants will be screened under Protocol #13-N-0017. Participants will have a 7-day inpatient stay, outpatient visits, and follow-up phone calls. Participants will have a medical history and physical exam. They will give urine samples. Blood will be drawn from an arm vein or through an intravenous (IV) catheter. Participants will get up to 3 doses of NT-I7. It will be given by injection into the muscle. Participants will have lumbar punctures ( spinal taps ). A thin needle will be inserted into the spinal canal in the lower back. Cerebrospinal fluid will be removed. X-ray may be used to guide the procedure. Participants will have magnetic resonance imaging (MRI) of the brain. The MRI scanner is a metal cylinder surrounded by a magnetic field. During MRIs, participants will lie on a table that slides in and out of the scanner. Soft padding or a coil will be placed around their head. They will get gadolinium, a contrast agent, through an IV catheter. Participation will last for 12 to 19 months. ...
Conditions Studied
Interventions
- DRUG NT-I7
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-05-05 |
| Est. Completion | 2025-11-07 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04781309
The ClinicalTrials.gov registry entry for NCT04781309 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 255-participant average among 3 other Progressive Multifocal Leukoencephalopathy trials with a reported enrollment target (95% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Progressive Multifocal Leukoencephalopathy appearing as the primary indexed condition, and to 1 intervention - of which NT-I7 is the first listed.
NCT04781309 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04781309 about?
NCT04781309 is a clinical study titled "NT-I7, a Long-Acting Recombinant IL-7 Molecule, as an Immune Reconstitution Strategy for Lymphopenia in Patients With Progressive Multifocal Leukoencephalopathy". Background: Progressive multifocal leukoencephalopathy (PML) is a brain infection. It is caused by a virus. PML can happen in people with a weakened immune system. PML is associated with cognitive and visual impairment as well as motor and speech disturbances. There is no treatment for PML. Researc...
What is the current status of trial NCT04781309?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2021-05-05. Estimated completion is 2025-11-07.
What conditions does trial NCT04781309 study?
This clinical trial studies the following conditions: Progressive Multifocal Leukoencephalopathy.
What interventions are being tested in trial NCT04781309?
The interventions under investigation include: NT-I7 (DRUG).
Who is sponsoring clinical trial NCT04781309?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04781309 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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