Dose-finding, Safety and Efficacy Study of NV1FGF in Patients With Intermittent Claudication

Phase 2

Completed

• Conditions: Peripheral Arterial Occlusive Disease
• Interventions: Drug: placebo; Drug: XRP0038 (NV1FGF)

• Registration Number: NCT01157871
• Lead Sponsor: Sanofi

Brief Summary

The primary objective is to assess safety and efficacy of two different doses of NV1FGF as compared to placebo.

The secondary objective is to assess the pharmacokinetics of NV1FGF and FGF-1 protein.

Detailed Description

Screening of 1 to 4 weeks before study drug administration; 6 weeks of treatment, followed by 20 weeks of follow-up.

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Status Verified: 2010-07
• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-06
• Last Update Submitted: 2010-07-06
• Study First Posted: 2010-07-07
• Last Update Posted: 2010-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	4 administrations at 2-week interval of placebo solution
NV1FGF 16 mg	XRP0038 (NV1FGF)	4 administrations at 2-week interval of 4mg at each administration
NV1FGF 32 mg	XRP0038 (NV1FGF)	4 administrations at 2-week interval of 8mg at each administration

Primary Outcome Measures

Name	Time	Method
Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13	13 weeks

Secondary Outcome Measures

Name	Time	Method
NV1FGF DNA 69 base pair (bp) in plasma	up to week 27
NV1FGF DNA 825 bp in plasma	up to week 27
FGF-1 in plasma	up to week 27
Anti-FGF1 antibodies in serum	up to week 27