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NCT01157143 · ClinicalTrials.gov registry record · Phase 1
Gene Expression and Tolerability Study of NV1FGF in Patients With Peripheral Artery Occlusive Disease Planned to Undergo Major Amputation
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01157143 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 6 participants.
The verdict
NCT01157143, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The primary objective is to evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue, at injection site, after Intra Muscular (IM) administration of increasing single doses of NV1FGF. Secondary objectives : * To evaluate the safety and tolerability of IM administration of increasing single doses of NV1FGF * To evaluate the transgene expression (FGF-1 protein) in injected tissues (injection site and remote site) * To evaluate the presence of FGF-1 receptors in injected tissues (injection site and remote site) * To evaluate the NV1FGF biodistribution in injected tissues (injection site and remote site), in multiple organs/tissues when appropriate, and plasma * To evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue at remote site * To collect data from plasma NV1FGF pharmacokinetics * To evaluate healing of the amputation site
Interventions
- DRUG XRP0038 (NV1FGF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2002-01 |
| Est. Completion | 2003-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01157143
The ClinicalTrials.gov registry entry for NCT01157143 describes a study currently listed as completed, 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. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which XRP0038 (NV1FGF) is the first listed.
NCT01157143 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01157143 about?
NCT01157143 is a clinical study titled "Gene Expression and Tolerability Study of NV1FGF in Patients With Peripheral Artery Occlusive Disease Planned to Undergo Major Amputation". The primary objective is to evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue, at injection site, after Intra Muscular (IM) administration of increasing single doses of NV1FGF. Secondary objectives : * To evaluate the safety and tolerability of IM administration of inc...
What is the current status of trial NCT01157143?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2002-01. Estimated completion is 2003-10.
What interventions are being tested in trial NCT01157143?
The interventions under investigation include: XRP0038 (NV1FGF) (DRUG).
Who is sponsoring clinical trial NCT01157143?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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