Dose-finding, Safety and Efficacy Study of NV1FGF in Patients With Intermittent Claudication (TALISMAN 211)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01157871
First received: July 6, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Occlusive Disease
Drug: XRP0038 (NV1FGF)
Drug: placebo
Phase 2

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

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in Absolute Claudication Distance (ACD) evaluated by treadmill test at week 13 [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NV1FGF DNA 69 base pair (bp) in plasma [ Time Frame: up to week 27 ] [ Designated as safety issue: No ]
  • NV1FGF DNA 825 bp in plasma [ Time Frame: up to week 27 ] [ Designated as safety issue: No ]
  • FGF-1 in plasma [ Time Frame: up to week 27 ] [ Designated as safety issue: No ]
  • Anti-FGF1 antibodies in serum [ Time Frame: up to week 27 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: June 2004
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: placebo
4 administrations at 2-week interval of placebo solution
Drug: placebo

Pharmaceutical form:solution

Route of administration: intramuscular

Experimental: NV1FGF 16 mg
4 administrations at 2-week interval of 4mg at each administration
Drug: XRP0038 (NV1FGF)

Pharmaceutical form:solution

Route of administration: intramuscular

Experimental: NV1FGF 32 mg
4 administrations at 2-week interval of 8mg at each administration
Drug: XRP0038 (NV1FGF)

Pharmaceutical form:solution

Route of administration: intramuscular


Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157871

Locations
United States, Minnesota
Minneapolis, Minnesota, United States
Belgium
Bruxelles, Belgium
Germany
Münster, Germany
Switzerland
Bern, Switzerland
Sponsors and Collaborators
Sanofi
Investigators
Study Director: International Clinical Development Study Director Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: International Clinical Development Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT01157871     History of Changes
Other Study ID Numbers: ACT6141, PM211
Study First Received: July 6, 2010
Last Updated: July 6, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Intermittent Claudication
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Signs and Symptoms
Atherosclerosis
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014