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

Peripheral Arterial Occlusive Disease Clinical Trial

— TALISMAN 211  

Official title:

Double-blind, Randomized, Placebo-controlled, Parallel Group and Dose-finding, Multicentric, Safety and Efficacy Study With Intramuscular Injections of NV1FGF in Subjects With Intermittent Claudication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157871
• Other study ID #: ACT6141
• Secondary ID: PM211
• Status: Completed
• Phase: Phase 2
• First received: July 6, 2010
• Last updated: July 6, 2010
• Start date: June 2004
• Est. completion date: August 2005

Study information

• Verified date: July 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion criteria:

• Age>40 years

• History of typical intermittent claudication lasting for at least 3 months, showing no improvement and consistent with treadmill test findings

• Objective evidence of Peripheral Arterial Occlusive Disease. After 10 minutes of rest, either by Ankle brachial index measure (ABI) <0.8 or Systolic ankle pressure (AP) < 50 mmHg or Systolic toe pressure <50 mmHg

• Patent femoral inflow above the level of injections recently (<2 weeks) documented either with Doppler ultrasonography or Magnetic Resonance Angiography or Angiography

Exclusion criteria:

• Evidence of other causes for leg pain other than intermittent claudication.

• Illnesses limiting subject exercise capacity (angina pectoris, heart failure, respiratory disease, orthopaedic disease, neurological disorders…)

• Pain at rest

• Buerger's disease

• Positive serology for HIV 1 or 2, positive serology hepatitis B or C.

• Subjects with serum creatinine > 2 mg/dl (176 µmol/l) and subjects on dialysis.

• Active proliferative retinopathy defined by the presence of new vessel formation and scarring.

• Subjects who had a stroke or neurologic deficit presumed to be due to stroke within 3 months prior to the first administration of study treatment

• Previous treatment with any angiogenic growth factor

• Pregnant or breast feeding women or who disagree to practice a medically accepted method of birth control. Men and women who do not agree to use condoms as the only accepted protection barrier, for the entire study period

• Serious concomitant medical conditions not adequately controlled.

• Current alcohol or drug abuse

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease

Intervention

Drug:
• XRP0038 (NV1FGF)
Pharmaceutical form:solution Route of administration: intramuscular
• placebo
Pharmaceutical form:solution Route of administration: intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13		13 weeks	No
Secondary	NV1FGF DNA 69 base pair (bp) in plasma		up to week 27	No
Secondary	NV1FGF DNA 825 bp in plasma		up to week 27	No
Secondary	FGF-1 in plasma		up to week 27	No
Secondary	Anti-FGF1 antibodies in serum		up to week 27	No