A Phase IIB Pilot Study to Confirm the Feasibility and Tolerability of a Modified Dosage Regimen of AMG0001 in Subjects With Critical Limb Ischemia

AnGes USA, Inc.1 site in 1 country10 target enrollmentNovember 2013

ConditionsCritical Limb Ischemia Vascular Diseases Peripheral Arterial Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Critical Limb Ischemia
Sponsor: AnGes USA, Inc.
Enrollment: 10
Locations: 1
Primary Endpoint: Number of Participants With Adverse Events (AEs) Suspected to be Related to Injections of AMG0001
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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)

Detailed Description

The primary objectives of the study are: 1. To confirm the feasibility of study-related activities and the tolerability of a modified dosage regimen of AMG0001 in CLI 2. To evaluate safety of AMG0001

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

March 31, 2018

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AnGes USA, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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.
•Evidence or history of malignant neoplasm (clinical, laboratory or imaging) except for successfully excised basal cell or squamous cell carcinoma, or successfully excised early melanoma of the skin. Subjects, who had successful tumor resection or radio-chemotherapy of breast cancer more than 10 years prior to inclusion in the study, and with no recurrence, may be enrolled in the study. Subjects, who had successful tumor resection or radio-chemotherapy of all other tumor types and have been in remission for more than 5 years prior to inclusion in the study, and with no recurrence, may be enrolled in the study. A dermatological exam will have ruled out any skin cancer.
•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.

Outcomes

Primary Outcomes

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

Time Frame: 18 months

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).

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

Time Frame: up to 18 Months

Secondary Outcomes

Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg)(18 months)
Number of Participants in Whom the Largest Ulcer Healed Completely or Gets Smaller (Photo Confirmation)(18 Months)
Change From Baseline of VascuQol Score for the Index Limb by Visit(18 months)
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death(18 months)
Number of Participants With Shift From Baseline in Rutherford Classification(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 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)
Change in Hemodynamic Measurement of Baseline Calculated Toe Brachial Index (TBI) of the Index Leg by Visit(18 months)
Change in Hemodynamic Measurement of Baseline Calculated ABI of the Index Leg by Visit(18 months)
Number of Participants With Worsening CLI Event of Index Leg(18 months)