Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04693598 · ClinicalTrials.gov registry record · Phase 1
Gene Transfer Clinical Trial for Krabbe Disease
A Phase 1 study of Krabbe Disease, sponsored by Forge Biologics.
- Active
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT04693598 is a Phase 1 study of Krabbe Disease that is active but no longer recruiting, run by Forge Biologics. The registered enrollment target is 6 participants, below the 417-participant average among 4 other Krabbe Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04693598, a Phase 1 study of Krabbe Disease, is active but no longer recruiting, sponsored by Forge Biologics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a nonblinded, non-randomized dose escalation study of intravenous AAVrh10 after hematopoietic stem cell transplantation (HSCT) in which subjects will receive standard of care hematopoietic cell transplantation for Krabbe disease, followed by a single infusion of an adeno-associated virus gene therapy product. Extensive natural history subjects will be used to compare as control group.
Conditions Studied
Interventions
- BIOLOGICAL FBX-101
Study Locations (1)
Michigan
- University of Michigan Hospitals - Michigan Medicine - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-11-05 |
| Est. Completion | 2026-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04693598
The ClinicalTrials.gov registry entry for NCT04693598 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 417-participant average among 4 other Krabbe Disease trials with a reported enrollment target (99% lower). The listed sponsor is Forge Biologics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Krabbe Disease appearing as the primary indexed condition, and to 1 intervention - of which FBX-101 is the first listed.
NCT04693598 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT04693598 about?
NCT04693598 is a clinical study titled "Gene Transfer Clinical Trial for Krabbe Disease". This is a nonblinded, non-randomized dose escalation study of intravenous AAVrh10 after hematopoietic stem cell transplantation (HSCT) in which subjects will receive standard of care hematopoietic cell transplantation for Krabbe disease, followed by a single infusion of an adeno-associated virus gen...
What is the current status of trial NCT04693598?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2021-11-05. Estimated completion is 2026-11.
What conditions does trial NCT04693598 study?
This clinical trial studies the following conditions: Krabbe Disease.
What interventions are being tested in trial NCT04693598?
The interventions under investigation include: FBX-101 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04693598?
This trial is sponsored by Forge Biologics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04693598 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Krabbe Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Gene Transfer Clinical Trial for Infantile and Late Infantile Krabbe Disease Treated Previously With HSCT
ACTIVE NOT RECRUITING · Phase 1
-
Krabbe Disease Global Patient Registry
RECRUITING
-
Longitudinal Study of Neurodegenerative Disorders
RECRUITING
-
Diffusion Tensor Imaging (DTI) in Infants With Krabbe Disease
ACTIVE NOT RECRUITING
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.