FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00424866|
Recruitment Status : Not yet recruiting
First Posted : January 22, 2007
Last Update Posted : January 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease Stenosis Intermittent Claudication||Drug: FGF-1 Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 1, Open Label, Dose Response, Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 (FGF-1) in Peripheral Arterial Disease Patients With Intermittent Claudication|
|Anticipated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||December 15, 2019|
|Estimated Study Completion Date :||June 2020|
Placebo Comparator: Placebo
The dosing groups correspond to total doses of 0 µg/kg of FGF-1.
Vehicle: 0 µg/kg
Active Comparator: Human FGF-1
The dosing groups correspond to total doses of either 3, 10 or 30 µg/kg of FGF-1.
Doses of FGF-1: 3 ug/kg; 10 ug/kg; 30 ug/kg
Low dose: 3.0 μg/kg Mid dose: 10 μg/kg High dose: 30 µg/kg
Other Name: Acidic FGF
- Safety [ Time Frame: 12 weeks ]The main objective of this study is to evaluate the safety and tolerability of FGF-1 in patients with peripheral arterial disease and intermittent claudication. Vital signs, physical examinations, safety laboratory evaluations and total number of adverse events will be captured and analyzed accordingly.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424866
|Contact: Vance O Gardner, MD||(972) 681-9368||VGardner@CVBT.com|
|Contact: Laurence R Meyerson, PhD||(972) 681-9368||LMeyerson@CVBT.com|
|United States, Virginia|
|Univ. Virginia||Active, not recruiting|
|Charlottesville, Virginia, United States, 22901|
|Study Director:||Brian Annex, MD||Univ. Virgina|