Critical Limb IschemiaPhase 2NCT01410331
Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Critical Limb Ischemia
A Phase 2 study of Critical Limb Ischemia, run by Juventas Therapeutics, Inc. at 7 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Critical Limb Ischemia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Mar 2012to Jul 2014
- 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
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Summa Health System
Akron, Ohio, 44304
Cardiology PC
Birmingham, Alabama, 35211
Northwestern Memorial Hospital/Northwestern University
Chicago, Illinois, 60611
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Montefiore Medical Center
The Bronx, New York, 10467
India2 sites
Medanta-The Medicity
Haryāna, 122001
Sir Ganga Ram Hospital
New Delhi, 110060
About this study
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
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).
Read the 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.
- Conditions
- Critical Limb Ischemia
- Being tested
- 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
- Keywords
- CLI, peripheral vascular disease, PVD, PAD, SDF-1
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JVS-100(4 mg) or placebo/8 injectionsBiological
4 mg of JVS-100 or placebo delivered in 8 injections
JVS-100(8 mg) or placebo/8 injectionsBiological
8 mg of JVS-100 or placebo delivered in 8 injections
JVS-100(8 mg) or placebo/16 injectionsBiological
8 mg of JVS-100 or placebo delivered in 16 injections
JVS-100(16 mg) or placebo/16 injectionsBiological
16 mg of JVS-100 or placebo delivered in 16 injections
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Subjects will be randomized to receive either 4 mg of JVS-100 or placebo over 8 injections. Receives: Biological: JVS-100(4 mg) or placebo/8 injections |
| Cohort 2 | Experimental | Subjects will be randomized to receive either 8 mg of JVS-100 or placebo over 8 injections. Receives: Biological: JVS-100(8 mg) or placebo/8 injections |
| Cohort 3 | Experimental | Subjects will be randomized to receive either 8 mg of JVS-100 or placebo over 16 injections. Receives: Biological: JVS-100(8 mg) or placebo/16 injections |
| Cohort 4 | Experimental | Subjects will be randomized to receive either 16 mg of JVS-100 or placebo over 16 injections. Receives: Biological: JVS-100(16 mg) or placebo/16 injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 Months
Secondary outcomes (1)
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.
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 posted5 Aug 2011 (estimated)
- Study startMar 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juventas Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melina Kibbe, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410331
- Sponsor's protocol ID
- JTCS-002
- Status last verified
- Oct 2014
- First submitted
- 14 Jul 2011
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01410331
- Acronym / sponsor ID
- JTCS-002
- Conditions
- Critical Limb Ischemia
- Keywords
- CLI, peripheral vascular disease, PVD, PAD, SDF-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Juventas Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Aug 2011 (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.
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.
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 |
|---|---|---|
| Cohort 1 | Experimental | Biological: JVS-100(4 mg) or placebo/8 injectionsSubjects will be randomized to receive either 4 mg of JVS-100 or placebo over 8 injections. |
| Cohort 2 | Experimental | Biological: JVS-100(8 mg) or placebo/8 injectionsSubjects will be randomized to receive either 8 mg of JVS-100 or placebo over 8 injections. |
| Cohort 3 | Experimental | Biological: JVS-100(8 mg) or placebo/16 injectionsSubjects will be randomized to receive either 8 mg of JVS-100 or placebo over 16 injections. |
| Cohort 4 | Experimental | Biological: JVS-100(16 mg) or placebo/16 injectionsSubjects will be randomized to receive either 16 mg of JVS-100 or placebo over 16 injections. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 %
Key exclusion criteria (22 listed)
- 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
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 |
|---|---|---|
| JVS-100(4 mg) or placebo/8 injections4 mg of JVS-100 or placebo delivered in 8 injections | Biological | Cohort 1 |
| JVS-100(8 mg) or placebo/8 injections8 mg of JVS-100 or placebo delivered in 8 injections | Biological | Cohort 2 |
| JVS-100(8 mg) or placebo/16 injections8 mg of JVS-100 or placebo delivered in 16 injections | Biological | Cohort 3 |
| JVS-100(16 mg) or placebo/16 injections16 mg of JVS-100 or placebo delivered in 16 injections | Biological | Cohort 4 |
Primary outcome
To Investigate the safety and tolerability of escalating doses of JVS-100 delivered via direct intramuscular injections to subjects with CLI.
Time frame: 12 Months
Safety assessments include tracking of AEs and SAEs and laboratory assessments
1 secondary outcome
To investigate the initial efficacy of escalating doses of JVS-100 delivered via direct intramuscular injections to subjects with CLI.
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 23 Oct 2014.
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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.
Melina Kibbe, MD principal investigator
Northwestern University
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Critical Limb Ischemia, run by Juventas Therapeutics, Inc. at 7 sites in 2 countries.
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 7 inclusion and 22 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 23 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, India. 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. 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?
To Investigate the safety and tolerability of escalating doses of JVS-100 delivered via direct intramuscular injections to subjects with CLI. (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2014.