A Phase IIB Pilot Study of a Modified Dosage Regimen of AMG0001 in Subjects With Critical Limb Ischemia

NCT02016755 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AG-CLI-0209
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to confirm the feasibility of study procedures and the tolerability of a new dose regimen of AMG0001 in subjects with Critical Limb Ischemia (CLI)

Conditions

Critical Limb Ischemia; Vascular Diseases; Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; Vascular Disease; CLI; Critical Limb Ischemia; PAD; AnGes; HGF Plasmid; HGF; Hepatocyte Growth Factor Plasmid; gene therapy

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events (AEs) Suspected to be Related to Injections of AMG0001

  All summaries and analyses will be presented in tabular or graphical form. The study is not powered for the statistical inference and the test will be considered to be descriptive. Treatment-emergent adverse events (TEAEs) was evaluated, and a table showing the number and percentage of subjects with occurrences categorized by System Organ Class and Preferred Term was provided by causality (relationship to study drug).

  18 months

• Number of Participants Discontinued Due to AEs From the Injections of AMG0001

  All summaries and analyses will be presented in tabular or graphical form. The study is not powered for the statistical inference and the test will be considered to be descriptive. Treatment-emergent adverse events (TEAEs) was evaluated, and a table showing the number and percentage of subjects with occurrences categorized by System Organ Class and Preferred Term was provided by whether the AE led to discontinuation.

  up to 18 Months

Secondary Outcomes (11)

• Number of Participants in Whom the Largest Ulcer Healed Completely or Gets Smaller (Photo Confirmation)

  18 Months

• Number of Participants in Whom Rest Pain (Based on 10 cm VAS Scale) Reduces by 20 mm (2 cm) or More or Was Completely Relieved.

  18 months

• Change From Baseline of VascuQol Score for the Index Limb by Visit

  18 months

• Change in Hemodynamic Measurements of Change From Baseline Value of Toe Systolic Pressure (mmHg)

  18 months

• Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit

  18 months

Study Arms (1)

AMG0001

EXPERIMENTAL

Hepatocyte Growth Factor (HGF) Plasmid

Biological: HGF Plasmid

Interventions

HGF Plasmid BIOLOGICAL

Intramuscular injection in the affected limb.

Also known as: AMG0001

AMG0001

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with stable CLI (Severe Rutherford 4 and Rutherford 5) who have no option for revascularization by endovascular intervention or surgical bypass or a poor option (high risk) for revascularization by surgery and no option for an endovascular intervention
• Subjects 40-90 years of either gender who have signed an informed consent
• Subjects currently are taking a statin and an anti-platelet agent
• If female, the subjects must not be of child bearing potential, e.g., post-menopausal or surgically sterile.
• If a male subject is of reproductive potential, he must agree to use an accepted and effective (barrier) form of birth control starting with the first dose of study product and continue for 12 weeks from the last dose of study product.
• Subjects with a previous medical history of myocardial infarction and/or stroke should have adequate management of risk factors to prevent secondary occurrence.
• Subjects should have the ability to understand the requirements of the protocol and agree to return for the required study visits and assessments

You may not qualify if:

• Subjects whose CLI status is unstable (spontaneous marked improvement or marked worsening during the screening period).
• Subjects who may require a major amputation (amputation at or above the ankle) within 4 weeks of Day 0 (± 4 weeks of Day 0).
• Subjects with ulcers with exposure of tendons, osteomyelitis or uncontrolled infection or with the largest ulcer that is greater than 20 cm2 in area (\>10 cm2 area if on the heel).
• Subjects with purely neuropathic or venous ulcers.
• Subjects in Rutherford 6 class.
• Subjects who have had revascularization by surgery or angioplasty within 3 months, unless the procedure has failed based on the anatomy or the hemodynamic measurements.
• Subjects with a diagnosis of Buerger's disease (Thrombo-angiitis Obliterans).
• Subjects currently receiving immunosuppressive, chemo or radiation therapy.
• Subjects who have proliferative retinopathy, or moderate or severe non-proliferative retinopathy, from any cause (ETDRS Score \> 35), clinically significant macular oedema or previous panretinal photocoagulation therapy.
• Subjects with severe renal disease defined as significant renal dysfunction evidenced by an estimated creatinine clearance of \<30 mL/minute (calculated using the Cockcroft Gault formula), or receiving chronic hemodialysis therapy.
• A Stroke, TIA or MI within 3 months of entry into the study.
• Subjects with known liver disease (e.g., hepatitis B or C or cirrhosis of the liver).
• A subject with HIV, AIDS, or severe uncontrolled ulcerative colitis or Crohn's disease.
• Subjects with a current, uncorrected history of alcohol or substance abuse.
• Subjects that have been administered rhPDGF (e.g, becaplermin) or other growth factors locally within one month of randomization.

Sponsors & Collaborators

• AnGes USA, Inc.: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Vascular Diseases; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Results Point of Contact

• Title: Dr. Susan Pitman Lowenthal
• Organization: AnGes USA, Inc.

spitmanlowenthal@anges-usa.com

240-780-9025

Study Officials

• Richard Powell, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 20, 2013
• Study Start: November 1, 2013
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: January 22, 2021
• Results First Posted: January 22, 2021

Record last verified: 2021-01

Locations

US (1)