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NCT00798005 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.

A Phase 2 study of Severe Peripheral Artery Occlusive Disease, sponsored by Sanofi.

Completed
Registry status
Phase 2
Development phase
71
Enrollment target
1
Study location

NCT00798005: Completed Phase 2 study of Severe Peripheral Artery Occlusive Disease, sponsored by Sanofi.

NCT00798005 is a Phase 2 study of Severe Peripheral Artery Occlusive Disease that has completed, run by Sanofi. The registered enrollment target is 71 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00798005, a Phase 2 study of Severe Peripheral Artery Occlusive Disease, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 2
Development phase
71 participants
Enrollment target
1
Study location

Study Summary

Peripheral Arterial Occlusive Disease (PAOD) is a condition caused by ischemia in the legs due to atherosclerotic disease affecting the larger arteries of the legs. Chronic PAOD can be regarded as a marker of generalized atherosclerosis. PAOD threatens the survival of an extremity and often causes lifelong disablement from a painful leg. The clinical consequences of PAOD include pain on walking (claudication), pain at rest and loss of tissue integrity in the distal limbs.A variety of medical therapies have been investigated for patients with PAOD. There is currently no evidence to suggest that any medical therapy is effective for patients with rest pain and/or ischemic ulcers. Also, the use of intramuscular angiogenic VEGF-A gene transfer has recently demonstrated a improvement in clinical and hemodynamic status in patients with severe PAOD

Interventions

  • DRUG XRP0038 (NV1FGF)

Study Locations (1)

New Jersey

  • Sanofi-Aventis Administrative Office - Bridgewater

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2002-06
Est. Completion 2005-07
Phase Phase 2
Sanofi

713 total trials

What the finished NCT00798005 record still lists

NCT00798005 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).

The record links to 1 condition, with Severe Peripheral Artery Occlusive Disease appearing as the primary indexed condition, and to 1 intervention - of which XRP0038 (NV1FGF) is the first listed.

NCT00798005 reports a single indexed study location in New Jersey.

Frequently Asked Questions

What is clinical trial NCT00798005 about?

NCT00798005 is a clinical study titled "Efficacy and Safety Study of NV1FGF in Patients With Severe Peripheral Artery Occlusive Disease.". Peripheral Arterial Occlusive Disease (PAOD) is a condition caused by ischemia in the legs due to atherosclerotic disease affecting the larger arteries of the legs. Chronic PAOD can be regarded as a marker of generalized atherosclerosis. PAOD threatens the survival of an extremity and often causes l...

What is the current status of trial NCT00798005?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2002-06. Estimated completion is 2005-07.

What conditions does trial NCT00798005 study?

This clinical trial studies the following conditions: Severe Peripheral Artery Occlusive Disease.

What interventions are being tested in trial NCT00798005?

The interventions under investigation include: XRP0038 (NV1FGF) (DRUG).

Who is sponsoring clinical trial NCT00798005?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00798005 being conducted?

This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT00798005's enrollment target sits among peer trials

71 936th of 2000 higher than 1,064 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00798005, the US trial registry maintained by the National Library of Medicine. NCT00798005 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.