Arterial Occlusive DiseasePhase 2NCT00060892
Study of HGF Via Plasmid Vector to Improve Perfusion in Critical Limb Ischemia
A Phase 2 study testing HGF plasmid in people with Arterial Occlusive Disease and Peripheral Vascular Disease, run by AnGes USA, Inc. at 24 sites in United States.
Trial summary
The primary purpose of this study was to assess the overall safety of different dose regimens of AMG0001 (HGF transferred via plasmid vector) as well as evaluate the improvement of blood perfusion in subjects with critical limb ischemia (CLI). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Arterial Occlusive Disease, Peripheral Vascular Disease, Ischemia
- What is being tested?
- HGF plasmid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 24 sitesUnited States
- Study dates
- Apr 2003to Jan 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will have one or more clinical indications diagnostic of CLI such as: distal extremity pain at rest that requires the subject to use analgesics for >2 weeks; or peripheral ischemic ulcer(s); or areas of gangrene.
- The subject will have a TcPO2 of </= 40 mmHg.
- Subjects will have one or both of the following hemodynamic indicators of severe peripheral arterial occlusive disease: (a) Ankle systolic pressure of </= 70 mmHg; (b)Toe systolic pressure </= 50 mmHg.
- The subject is a poor candidate for standard revascularization treatment options for peripheral arterial disease, based on inadequate bypass conduit, unfavorable anatomy, or poor operative risk.
- Subject has signed an informed consent form either directly or through a legally authorized representative
- If female, the subject must be (a) at least one year post-menopausal, or (b) surgically sterile, or (c) if the subject is of child-bearing potential, she must have been practicing contraception for at least 12 weeks prior to entering the study.
- If subject is of reproductive potential, he or she must be using an accepted and effective (barrier) form of birth control during the study.
- Subjects will be on a statin and an anti-platelet agent as part of their standard of care and must be stable on these regimens for at least 4 weeks prior to treatment.
Who cannot join
- Subjects, who in the opinion of the investigator, have a vascular disease prognosis that indicates they would require a major amputation (at or above the ankle) within 4 weeks of start of treatment.
- Subjects with a diagnosis of Buerger's disease (Thromboangitis Obliterans).
- Subjects with hemodynamically significant aorto-iliac occlusive disease.
- Subjects who have had a revascularization procedure within 12 weeks prior to treatment initiation that remains patent. Revascularization procedures that are evidenced to have failed for >2 weeks prior to treatment initiation are acceptable.
- Subjects who require a change in their hypertension medication as part of their standard of care within 4 weeks prior to treatment.
- Evidence or history of malignant neoplasm (clinical, laboratory or imaging), except for basal cell carcinoma of the skin.
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- Subjects who have proliferative diabetic retinopathy or severe, non-proliferative retinopathy
- Subjects with end stage renal disease (ESRD) defined as significant renal dysfunction evidenced by a creatinine of > 2.5, or receiving chronic hemodialysis therapy.
- A subject who has hepatic cirrhosis, viral hepatitis, or is HIV positive.
- Subjects with a clinically significant liver enzyme abnormality (i.e., AST or ALT more than two times the upper limit of normal and/or bilirubin more than 50% the upper limit of normal).
- Subjects requiring the use of hyperbaric oxygen treatment for wound healing during the screening and 6 month follow-up period.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
American Cardiovascular Research Institute
Atlanta, Georgia, 30342
Cardiology, P.C.
Birmingham, Alabama, 35211
University of Chicago Hospitals
Chicago, Illinois, 60637
The Lindner Clinical Trial Center
Cincinnati, Ohio, 45219
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Pitt County Memorial Hospital
Greenville, North Carolina, 27834
Baylor College of Medicine
Houston, Texas, 77030
The Care Group, LLC
Indianapolis, Indiana, 46290
Dartmouth - Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, 72205
Cedars-Sinai Medical Center
Los Angeles, California, 90048
The Ochsner Heart and Vascular Institute
Metairie, Louisiana, 70002
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Diabetes Foot and Ankle Center
New York, New York, 10003
NYPH-NY Weill Cornell Medical Center
New York, New York, 10021
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Basptist Hospital
Pensacola, Florida, 32501
University of Rochester
Rochester, New York, 14642
Peripheral Vascular Associates
San Antonio, Texas, 78215
Falk Cardiovascular Research Center
Stanford, California, 94305
University of South Florida College of Medicine
Tampa, Florida, 33606
Jobst Vascular Center
Toledo, Ohio, 43606
Medical College of Ohio
Toledo, Ohio, 43614
VA Medical Center Surgical Service (112)
Washington D.C., District of Columbia, 20422
About this study
Official title: A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of AMG0001 to Improve Perfusion in Critical Leg Ischemia
The primary purpose of this study was to assess the overall safety of different dose regimens of AMG0001 (HGF transferred via plasmid vector) as well as evaluate the improvement of blood perfusion in subjects with critical limb ischemia (CLI). This study also evaluated the improvement in wound healing without adverse effects on the quality of life, as well as the potential reduction of amputation, mortality and rest pain in the CLI population.
Read the detailed description
The primary goal of this study was to assess the safety of AMG0001, detect potential angiogenesis response to AMG0001 treatment and to correlate these changes to clinical endpoints dependent upon improvement in tissue perfusion for relief of CLI complications. The objectives of this study were to:
- Assess the overall safety of different exposure regimens of AMG0001 in the CLI subject population.
- Evaluate the potential effect of angiogenesis associated with different doses and dose regimens of AMG0001 as measured by improvement in tissue perfusion.
- Evaluate the activity of different exposure regimens of AMG0001 to benefit clinical outcomes of reduction of amputation and mortality, wound healing, rest-pain reduction and improvement in subject's ability to function without adverse consequences on quality of life.
- Being tested
- HGF plasmid
- Keywords
- Critical Limb Ischemia
- Medical subject headings
- Arterial Occlusive Diseases, Peripheral Vascular Diseases, Ischemia, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HGF plasmidGenetic
Intramuscular injections into index leg on Days 0, 14, and 28
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 0.4 mg AMG0001 on days 0, 14, and 28 Receives: Genetic: HGF plasmid |
| 2 | Active comparator | 4.0 mg AMG0001 on days 0, 14, and 28 Receives: Genetic: HGF plasmid |
| 3 | Active comparator | 4.0 mg AMG0001 on days 0 and 28; placebo on day 14 Receives: Genetic: HGF plasmid |
| 4 | Placebo comparator | Placebo (saline) on days 0, 14, and 28 Receives: Genetic: HGF plasmid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue perfusion as measured by TcPO2
Measured: 6 months
Secondary outcomes (1)
Ulcer healing
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2003 (estimated)
- Study startApr 2003
- Primary completionMay 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial Occlusive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- AnGes USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060892
- Sponsor's protocol ID
- AG-CLI-0202
- Status last verified
- Jan 2008
- First submitted
- 15 May 2003
- Last updated
- 11 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Powell RJ, Simons M, Mendelsohn FO, Daniel G, Henry TD, Koga M, Morishita R, Annex BH. Results of a double-blind, placebo-controlled study to assess the safety of intramuscular injection of hepatocyte growth factor plasmid to improve limb perfusion in patients with critical limb ischemia. Circulation. 2008 Jul 1;118(1):58-65. doi: 10.1161/CIRCULATIONAHA.107.727347. Epub 2008 Jun 16.
PubMed 18559703
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of AMG0001 to Improve Perfusion in Critical Leg Ischemia
- ClinicalTrials.gov ID
- NCT00060892
- Acronym / sponsor ID
- AG-CLI-0202
- Keywords
- Critical Limb Ischemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- AnGes USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- May 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 16 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study was to assess the overall safety of different dose regimens of AMG0001 (HGF transferred via plasmid vector) as well as evaluate the improvement of blood perfusion in subjects with critical limb ischemia (CLI). This study also evaluated the improvement in wound healing without adverse effects on the quality of life, as well as the potential reduction of amputation, mortality and rest pain in the CLI population.
Detailed description
The primary goal of this study was to assess the safety of AMG0001, detect potential angiogenesis response to AMG0001 treatment and to correlate these changes to clinical endpoints dependent upon improvement in tissue perfusion for relief of CLI complications. The objectives of this study were to:
- Assess the overall safety of different exposure regimens of AMG0001 in the CLI subject population.
- Evaluate the potential effect of angiogenesis associated with different doses and dose regimens of AMG0001 as measured by improvement in tissue perfusion.
- Evaluate the activity of different exposure regimens of AMG0001 to benefit clinical outcomes of reduction of amputation and mortality, wound healing, rest-pain reduction and improvement in subject's ability to function without adverse consequences on quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Genetic: HGF plasmid0.4 mg AMG0001 on days 0, 14, and 28 |
| 2 | Active comparator | Genetic: HGF plasmid4.0 mg AMG0001 on days 0, 14, and 28 |
| 3 | Active comparator | Genetic: HGF plasmid4.0 mg AMG0001 on days 0 and 28; placebo on day 14 |
| 4 | Placebo comparator | Genetic: HGF plasmidPlacebo (saline) on days 0, 14, and 28 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects will have one or more clinical indications diagnostic of CLI such as: distal extremity pain at rest that requires the subject to use analgesics for >2 weeks; or peripheral ischemic ulcer(s); or areas of gangrene.
- The subject will have a TcPO2 of </= 40 mmHg.
- Subjects will have one or both of the following hemodynamic indicators of severe peripheral arterial occlusive disease: (a) Ankle systolic pressure of </= 70 mmHg; (b)Toe systolic pressure </= 50 mmHg.
- The subject is a poor candidate for standard revascularization treatment options for peripheral arterial disease, based on inadequate bypass conduit, unfavorable anatomy, or poor operative risk.
- Subject has signed an informed consent form either directly or through a legally authorized representative
Key exclusion criteria (11 listed)
- Subjects, who in the opinion of the investigator, have a vascular disease prognosis that indicates they would require a major amputation (at or above the ankle) within 4 weeks of start of treatment.
- Subjects with a diagnosis of Buerger's disease (Thromboangitis Obliterans).
- Subjects with hemodynamically significant aorto-iliac occlusive disease.
- Subjects who have had a revascularization procedure within 12 weeks prior to treatment initiation that remains patent. Revascularization procedures that are evidenced to have failed for >2 weeks prior to treatment initiation are acceptable.
- Subjects who require a change in their hypertension medication as part of their standard of care within 4 weeks prior to treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HGF plasmidIntramuscular injections into index leg on Days 0, 14, and 28 | Genetic | 1, 2, 3, 4 |
Primary outcome
Tissue perfusion as measured by TcPO2
Time frame: 6 months
1 secondary outcome
Ulcer healing
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2008.
- Derived from this study: PubMed 18559703Powell RJ, Simons M, Mendelsohn FO, Daniel G, Henry TD, Koga M, Morishita R, Annex BH. Results of a double-blind, placebo-controlled study to assess the safety of intramuscular injection of hepatocyte growth factor plasmid to improve limb perfusion in patients with critical limb ischemia. Circulation. 2008 Jul 1;118(1):58-65. doi: 10.1161/CIRCULATIONAHA.107.727347. Epub 2008 Jun 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HGF plasmid in people with Arterial Occlusive Disease and Peripheral Vascular Disease, run by AnGes USA, Inc. at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tissue perfusion as measured by TcPO2 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00060892, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2008; AzTrials last refreshed its copy on 6 Nov 2026.