Safety and Efficacy Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 Gene Transfer in Patients With Intermittent Claudication

PHASE2CompletedINTERVENTIONAL
Enrollment

289

Participants

Timeline

Start Date

February 28, 2005

Primary Completion Date

September 30, 2008

Study Completion Date

March 31, 2010

Conditions
Intermittent ClaudicationPeripheral Vascular DiseaseAtherosclerosis
Interventions
BIOLOGICAL

Ad2/HIF-1α/VP16

a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections

BIOLOGICAL

Ad2/HIF-1α/VP16

one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections.

BIOLOGICAL

Ad2/HIF-1α/VP16

a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections.

OTHER

Saline (Placebo Control)

a one time treatment of 20 IM injections of 0.01 ML each into each leg for a total of 40 injections.

Trial Locations (47)

10003

New York University School of Medicine, New York

10029

Mount Sinai School of Medicine, New York

10365

Ev. Krankenhaus Königin Elisabeth, Berlin

12203

Charité Campus Benjamin Franklin, Berlin

14642

University of Rochester Medical Center, Rochester

20010

The Washington Hospital Center, Washington D.C.

21287

The Johns Hopkins Hospital, Baltimore

23538

Universitätsklinikum Schleswig Holstein/Campus Luebeck, Lübeck

27599

University of North Carolina at Chapel Hill, Chapel Hill

27705

Duke University Medical Center, Durham

30342

Saint Joseph's Research Institute, Atlanta

32522

Baptist Health Care, Pensacola

32701

Prairie Cardiovascular Consultants, Ltd., Springfield

33462

Palm Beach Heart Institute, Atlantis

33606

University of South Florida, Tampa

35211

Baptist Medical Center Princeton, Birmingham

43606

Jobst Vascular Center, Toledo

43614

Medical University of Ohio, Toledo

44195

Cleveland Clinic Foundation, Cleveland

46290

The Care Group at the Heart Center, Indianapolis

48126

Henry Ford Hospital, Detroit

48149

Universitätsklinikum Munster, Münster

55415

Minneapolis Heart Institute Foundation, Minneapolis

60612

Rush University Medical Center, Chicago

63104

Saint Louis University Hospital, St Louis

70002

Ochsner Clinic Foundation, Metairie

73190

University of Oklahoma, Health Sciences Center, Oklahoma City

75246

Baylor University Medical Center, Dallas

76307

Klinikum Karlsbad Langensteinbach gGmbH, Karlsbad

77030

Baylor College of Medicine, Houston

78205

Peripheral Vascular Associates, San Antonio

80262

University of Colorado Health Sciences Center, Denver

81377

Klinikum Grosshadern, Munich

94304

VA Palo Alto Health Care System, Palo Alto

94305

Stanford University School of Medicine, Stanford

95817

University of California at Davis, Sacramento

97239

Oregon Health & Science University, Portland

02114

Massachusetts General Hospital, Boston

02118

Boston Medical Center, Boston

02135

Caritas St. Elizabeth's Medical Center, CCP4C, Boston

03756

Dartmouth-Hitchcock Medical Center, Lebanon

BT9 7AB

Belfast City Hospital, Belfast

B29 6JD

Selly Oak Hospital, Birmingham

DD1 9SY

Ninewells Hospital & Medical School, Dundee

HU3 2JZ

Hull Royal Infirmary, Hull

SW17 0QT

St. George's Hospital and Medical School, London

UB1 3HW

Ealing Hospital, Southall, Middlesex

All Listed Sponsors
lead

Genzyme, a Sanofi Company

INDUSTRY

NCT00117650 - Safety and Efficacy Study of Ad2/Hypoxia Inducible Factor (HIF)-1α/VP16 Gene Transfer in Patients With Intermittent Claudication | Biotech Hunter | Biotech Hunter