search
Back to results

Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Critical Limb Ischemia

Primary Purpose

Critical Limb Ischemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JVS-100(4 mg) or placebo/8 injections
JVS-100(8 mg) or placebo/8 injections
JVS-100(8 mg) or placebo/16 injections
JVS-100(16 mg) or placebo/16 injections
Sponsored by
Juventas Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Limb Ischemia focused on measuring CLI, peripheral vascular disease, PVD, PAD, SDF-1

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women 40 years of age or older
  • Rutherford Category 4 or 5
  • Ankle systolic pressure of 70mmHg or less, or toe pressure of 50mmHg or less
  • Poor option for surgical revascularization by open or endovascular strategies
  • Those diabetic subjects who are on optimal diabetes treatment, with HbA1c <8.5 %
  • Subject should be on stable therapy for the treatment of CLI, including statin and antiplatelet therapy
  • Subject must be willing to forgo treatment with hyperbaric oxygen, nerve stimulation, ot sympathectomy for treatment of CLI 10 days prior to 45 days following injection of study drug

Exclusion Criteria:

  • Life expectancy of less than 1 year
  • Previous major amputation of the leg to be treated or planned major amputation within the first month following enrollment
  • Patent revascularization (within 6 weeks)in the leg to be treated prior to enrollment
  • NYHA Class IV heart failure
  • Evidence of osteomyelitis or active infection
  • Subjects with Buerger's Disease
  • Subjects with a history of Systemic Lupus Erythematosus (SLE) flare
  • Subjects with established chronic kidney (stage 5) requiring dialysis
  • Uncontrolled blood pressure
  • Significant hepatic disease
  • Diabetic subjects with active proliferative retinopathy
  • Immunodeficient states or subjects receiving chronic immunosuppressive therapy
  • Any patient with a history of cancer unless 1)the cancer was limited to curable non-melanoma skin malignancies, or 2)the cancer was removed by successful tumor resection, with or without radiation or chemotherapy, 5 years or more prior to enrollment in this study without recurrence
  • Pregnant or lactating women or subjects of childbearing potential not protected by an effective method of birth control
  • Men unwilling to agree to barrier contraception or limit sexual activity
  • Presence of any other condition that, in the opinion of the investigator, might compromise any aspect of the trial
  • Acute coronary syndrome within 3 month prior to enrollment
  • Previous treatment with angiogenic growth factors or with stem cell therapy within 1 year
  • Participation in another clinical trial in the last 30 days
  • Clinically significant elevations in PT/PTT/INR
  • Non-heel wound size >20 cm2 (excluding toe gangrene) or heel wound size >10cm2 on the index limb
  • History of drug or alcohol abuse in the last year

Sites / Locations

  • Cardiology PC
  • Northwestern Memorial Hospital/Northwestern University
  • Minneapolis Heart Institute Foundation
  • Montefiore Medical Center
  • Summa Health System
  • Medanta-The Medicity
  • Sir Ganga Ram Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Arm Description

Subjects will be randomized to receive either 4 mg of JVS-100 or placebo over 8 injections.

Subjects will be randomized to receive either 8 mg of JVS-100 or placebo over 8 injections.

Subjects will be randomized to receive either 8 mg of JVS-100 or placebo over 16 injections.

Subjects will be randomized to receive either 16 mg of JVS-100 or placebo over 16 injections.

Outcomes

Primary Outcome Measures

To Investigate the safety and tolerability of escalating doses of JVS-100 delivered via direct intramuscular injections to subjects with CLI.
Safety assessments include tracking of AEs and SAEs and laboratory assessments

Secondary Outcome Measures

To investigate the initial efficacy of escalating doses of JVS-100 delivered via direct intramuscular injections to subjects with CLI.
Efficacy measurements include: tracking of major/minor amputations,overall survival,Quality of Life,ulcer healing, & pressure assessments.

Full Information

First Posted
July 14, 2011
Last Updated
October 22, 2014
Sponsor
Juventas Therapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01410331
Brief Title
Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Critical Limb Ischemia
Official Title
A Phase II, Randomized, Double-Blind, Placebo Controlled Dose Escalation Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Direct Intramuscular Injection to Cohorts of Adults With Critical Limb Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Juventas Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a double-blind, placebo controlled study designed to evaluate the safety and efficacy of JVS-100 given to adult subjects with critical limb ischemia (CLI).
Detailed Description
48 subjects diagnosed with Rutherford Class 4-5 Critical Limb Ischemia (CLI) with non-healing ulcers and/or ischemic rest pain will be enrolled in this study designed to investigate the safety and efficacy of JVS-100. JVS-100 will be delivered by direct intramuscular injection into the limbs of study subjects. Subjects will be randomized to receive a single set of direct intramuscular injections of either JVS-100 or vehicle control and will be followed for 12 months post dosing. Safety and efficacy assessments will be collected at 3 days, 4 weeks and 3, 6 and 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia
Keywords
CLI, peripheral vascular disease, PVD, PAD, SDF-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Subjects will be randomized to receive either 4 mg of JVS-100 or placebo over 8 injections.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Subjects will be randomized to receive either 8 mg of JVS-100 or placebo over 8 injections.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Subjects will be randomized to receive either 8 mg of JVS-100 or placebo over 16 injections.
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Subjects will be randomized to receive either 16 mg of JVS-100 or placebo over 16 injections.
Intervention Type
Biological
Intervention Name(s)
JVS-100(4 mg) or placebo/8 injections
Intervention Description
4 mg of JVS-100 or placebo delivered in 8 injections
Intervention Type
Biological
Intervention Name(s)
JVS-100(8 mg) or placebo/8 injections
Intervention Description
8 mg of JVS-100 or placebo delivered in 8 injections
Intervention Type
Biological
Intervention Name(s)
JVS-100(8 mg) or placebo/16 injections
Intervention Description
8 mg of JVS-100 or placebo delivered in 16 injections
Intervention Type
Biological
Intervention Name(s)
JVS-100(16 mg) or placebo/16 injections
Intervention Description
16 mg of JVS-100 or placebo delivered in 16 injections
Primary Outcome Measure Information:
Title
To Investigate the safety and tolerability of escalating doses of JVS-100 delivered via direct intramuscular injections to subjects with CLI.
Description
Safety assessments include tracking of AEs and SAEs and laboratory assessments
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
To investigate the initial efficacy of escalating doses of JVS-100 delivered via direct intramuscular injections to subjects with CLI.
Description
Efficacy measurements include: tracking of major/minor amputations,overall survival,Quality of Life,ulcer healing, & pressure assessments.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women 40 years of age or older Rutherford Category 4 or 5 Ankle systolic pressure of 70mmHg or less, or toe pressure of 50mmHg or less Poor option for surgical revascularization by open or endovascular strategies Those diabetic subjects who are on optimal diabetes treatment, with HbA1c <8.5 % Subject should be on stable therapy for the treatment of CLI, including statin and antiplatelet therapy Subject must be willing to forgo treatment with hyperbaric oxygen, nerve stimulation, ot sympathectomy for treatment of CLI 10 days prior to 45 days following injection of study drug Exclusion Criteria: Life expectancy of less than 1 year Previous major amputation of the leg to be treated or planned major amputation within the first month following enrollment Patent revascularization (within 6 weeks)in the leg to be treated prior to enrollment NYHA Class IV heart failure Evidence of osteomyelitis or active infection Subjects with Buerger's Disease Subjects with a history of Systemic Lupus Erythematosus (SLE) flare Subjects with established chronic kidney (stage 5) requiring dialysis Uncontrolled blood pressure Significant hepatic disease Diabetic subjects with active proliferative retinopathy Immunodeficient states or subjects receiving chronic immunosuppressive therapy Any patient with a history of cancer unless 1)the cancer was limited to curable non-melanoma skin malignancies, or 2)the cancer was removed by successful tumor resection, with or without radiation or chemotherapy, 5 years or more prior to enrollment in this study without recurrence Pregnant or lactating women or subjects of childbearing potential not protected by an effective method of birth control Men unwilling to agree to barrier contraception or limit sexual activity Presence of any other condition that, in the opinion of the investigator, might compromise any aspect of the trial Acute coronary syndrome within 3 month prior to enrollment Previous treatment with angiogenic growth factors or with stem cell therapy within 1 year Participation in another clinical trial in the last 30 days Clinically significant elevations in PT/PTT/INR Non-heel wound size >20 cm2 (excluding toe gangrene) or heel wound size >10cm2 on the index limb History of drug or alcohol abuse in the last year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melina Kibbe, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Northwestern Memorial Hospital/Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Medanta-The Medicity
City
Haryana
ZIP/Postal Code
122001
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Critical Limb Ischemia

We'll reach out to this number within 24 hrs