Lower Limb IschemiaPhase 4NVG-LIGHTNCT02369809
Non-Interventional Post Marketing Surveillance Study of Neovasculgen® in Patients With Chronic Lower Limb Ischemia
A Phase 4 study testing Neovasculgen® in people with Lower Limb Ischemia, run by Artgen Biotech at 30 sites in Russia.
Trial summary
Aim of the study is to gain more knowledge about efficacy and safety of Neovasculgen® in daily clinical practice and obtain information about the quality of life in patients treated with Neovasculgen®. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Lower Limb Ischemia
- What is being tested?
- Neovasculgen®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 30 sitesRussia
- Study dates
- Sep 2012to Jan 2017
- Phase
- Phase 4
- 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
- Male or female person aged 40 or older
- Subject with diagnosed lower limb ischemia (Fontaine-Pokrovsky Stages IIa-III of chronic limb ischemia)
- Signed informed consent
Who cannot join
- Any disease that can, in the opinion of the treating physician, affect the outcome of the study
- Patients with addictive disorders or substance abuse
- Pregnancy or nursing
- All other exclusion criteria listed in the summary of product characteristics (SmPC)
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Russia30 sites
"Clinical Hospital Station Barnaul Joint Stock Company" Russian Railways ", Non-governmental Health Care Institution
Barnaul, Altayskiy Kray, 656038
State Institution of Health Amur Region "Amur Regional Clinical Hospital"
Blagoveshchensk, Amur Oblast, 675028
Municipal Budget Health Care Institution "City Clinical Hospital № 8". Chelyabinsk
Chelyabinsk, Chelyabinsk Oblast, 454071
State Health Care Institution "Regional Clinical Hospital"
Chita, Zabaikalskii Region, 672038
Autonomous Healthcare Institution "Irkutsk Clinical Hospital #1 "
Irkutsk, Irkutsk Oblast, 664046
State Institution of Health Irkutsk "Badge of Honor" Regional Hospital
Irkutsk, Irkutsk Oblast, 664079
Public Health Autonomous Institution "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"
Kazan', Tatarstan Republic, 420064
State Institution of Health of Kemerovo Region "Kemerovo Regional Hospital"
Kemerovo, Kemerovo Oblast, 650066
Russian Academy Of Medical Sciences. Reserch Institute For Complex Problems Of Cardiovascular Diseases
Kemerovo, Kemerovskaya, 650002
Regional State Budget Institution of Additional Professional Education "Institute of Institute for Advanced Studies of Health Professionals" of the Ministry of Health of the Khabarovsk Region
Khabarovsk, Khabarovskiy Kray, 680009
Regional Clinical Hospital #1 Named after Prof. S.V.Ochapovskogo of the Ministry of Health of Krasnodar Region
Krasnodar, Krasnodarskiy Kray, 350086
Municipal Budget Health Institution "City Clinical Hospital of Emergency Medical Care Named after N.C Karpovich "
Krasnoyarsk, Krasnoyarsk Region, 660062
Federal State Institution "GBUZ MO MONIKI Named after M.F. Vladimirskogo "
Moscow, Moscow Oblast, 129110
State Institution of Health of Novosibirsk Region "City Clinical Hospital #1"
Novosibirsk, Novosibirsk Oblast, 630047
Federal State Institution "Research Institute of Clinical and Experimental Lymphology"
Novosibirsk, Novosibirsk Oblast, 630117
Budget Health Care Institution of Omsk Region "Regional Hospital"
Omsk, Omsk Oblast, 644111
State Educational Institution of Higher Professional Education "Rostov State Medical University"
Rostov-on-Don, Rostovskaya, 344022
St. Petersburg Research Institute of Emergency Care named after I.I. Dzhanelidze
Saint Petersburg, Sankt-Peterburg, 192242
State Institution of Health "Salekhard District Hospital"
Salekhard, Yamal-Nenets, 629001
State Budgetary Healthcare Institution "Samara Regional Clinical Hospital Named after M.I. Kalinin "
Samara, Samara Oblast, 443095
Budgetary State Institution Samara Region Hospital # 2 Named after V.V. Banykin
Tolyatti, Samara Rigion, 445023
Budgetary State Institution "Regional Hospital"
Tver', Tver Oblast, 170020
State Institution of Health of the Tyumen region "Regional Clinical Hospital #1"
Tyumen, Khanty-Mansiysk District, 625023
City Clinical Hospital # 21 Ufa
Ufa, Bashkortastan, 450071
State Budgetary Healthcare Institution "Republican Clinical Hospital Named after N.A Semashko "
Ulan-Ude, Buryatiya Republic, 670031
Public Health Institution "Primorsky Regional Clinical Hospital #1",
Vladivostok, Primorskiy (Maritime) Kray, 690091
Voronezh State Medical Academy Named After N.N Burdenko
Voronezh, Voronezh Oblast, 394036
State Institution of Health Yaroslavl Region "Clinical Hospital # 10"
Yaroslavl, Yaroslavl Oblast, 150023
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, Sverdlovsk Oblast, 620102
Republican Clinical Hospital
Yoshkar-Ola, Mari El Republic, 424037
About this study
Official title: International Postmarketing Surveillance Study of Pl-VEGF165 Safety and Efficacy in 210 Patients With Peripheral Arterial Disease
Aim of the study is to gain more knowledge about efficacy and safety of Neovasculgen® in daily clinical practice and obtain information about the quality of life in patients treated with Neovasculgen®.
Read the detailed description
This is an open, controlled, prospective, comparative, multicentre study design. All patients received standard conservative therapy for chronic limb ischemia without cilostazol and prostaglandins and without surgical or endovascular vessel reconstruction. Surgical and endovascular vessel reconstruction was unsuitable for all of the patients
- Conditions
- Lower Limb Ischemia
- Being tested
- Neovasculgen®
- Keywords
- Ischemia
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neovasculgen®Drug
Also called Neovasculgen
Treatment according to routine clinical practice at the discretion of the treating physician. Patients receive two local intramuscular injections of Neovasculgen® at a course dose of 2.4 mg according to the summary of product characteristics (SmPC).
| Study group | Role | What they receive |
|---|---|---|
| Neovasculgen® | Experimental | Single group prospective treatment Receives: Drug: Neovasculgen® |
| standard care | Active comparator | Not described Receives: Drug: Neovasculgen® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the measurement of pain-free walking distance (PWD) on treadmill
Measured: 3 months and 6 months after the first injection of Neovasculgen®.
Secondary outcomes (4)
Number of adverse drug reactions (ADRs) and unexpected adverse drug reactions (UADRs)
Measured: From the first injection of Neovasculgen® until six months after the secondary injection of Neovasculgen®
Change in the ankle-brachial index (ABI) after injection of Neovasculgen®
Measured: 3 months and 6 months after the first injection of Neovasculgen®
Change in blood flow linear velocity (BFLV) after injection of Neovasculgen®
Measured: 3 months and 6 months after the first injection of Neovasculgen®
Change in transcutaneous oxygen tension measurements (TcPO2) after injection of Neovasculgen®
Measured: 3 months and 6 months after the first injection of Neovasculgen®
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startSep 2012
- Primary completionJan 2017
- Study completionJan 2017
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 Lower 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artgen Biotech
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roman V Deev, MD, Study director, +7 495 646 80 76
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369809
- Sponsor's protocol ID
- NVG-03
- Acronym
- NVG-LIGHT
- Status last verified
- Feb 2015
- First submitted
- 17 Feb 2015
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Deev R, Plaksa I, Bozo I, Isaev A. Results of an International Postmarketing Surveillance Study of pl-VEGF165 Safety and Efficacy in 210 Patients with Peripheral Arterial Disease. Am J Cardiovasc Drugs. 2017 Jun;17(3):235-242. doi: 10.1007/s40256-016-0210-3.
PubMed 28050885
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Postmarketing Surveillance Study of Pl-VEGF165 Safety and Efficacy in 210 Patients With Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT02369809
- Acronym / sponsor ID
- NVG-LIGHT / NVG-03
- Conditions
- Lower Limb Ischemia
- Keywords
- Ischemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Artgen BiotechUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 24 Feb 2015 (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.
Aim of the study is to gain more knowledge about efficacy and safety of Neovasculgen® in daily clinical practice and obtain information about the quality of life in patients treated with Neovasculgen®.
Detailed description
This is an open, controlled, prospective, comparative, multicentre study design. All patients received standard conservative therapy for chronic limb ischemia without cilostazol and prostaglandins and without surgical or endovascular vessel reconstruction. Surgical and endovascular vessel reconstruction was unsuitable for all of the patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neovasculgen® | Experimental | Drug: Neovasculgen®Single group prospective treatment |
| standard care | Active comparator | Drug: Neovasculgen® |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female person aged 40 or older
- Subject with diagnosed lower limb ischemia (Fontaine-Pokrovsky Stages IIa-III of chronic limb ischemia)
- Signed informed consent
Key exclusion criteria (4 listed)
- Any disease that can, in the opinion of the treating physician, affect the outcome of the study
- Patients with addictive disorders or substance abuse
- Pregnancy or nursing
- All other exclusion criteria listed in the summary of product characteristics (SmPC)
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 |
|---|---|---|
| Neovasculgen®Also: NeovasculgenTreatment according to routine clinical practice at the discretion of the treating physician. Patients receive two local intramuscular injections of Neovasculgen® at a course dose of 2.4 mg according to the summary of product characteristics (SmPC). | Drug | Neovasculgen®, standard care |
Primary outcome
Change in the measurement of pain-free walking distance (PWD) on treadmill
Time frame: 3 months and 6 months after the first injection of Neovasculgen®.
4 secondary outcomes
Number of adverse drug reactions (ADRs) and unexpected adverse drug reactions (UADRs)
Time frame: From the first injection of Neovasculgen® until six months after the secondary injection of Neovasculgen®
Change in the ankle-brachial index (ABI) after injection of Neovasculgen®
Time frame: 3 months and 6 months after the first injection of Neovasculgen®
Change in blood flow linear velocity (BFLV) after injection of Neovasculgen®
Time frame: 3 months and 6 months after the first injection of Neovasculgen®
Change in transcutaneous oxygen tension measurements (TcPO2) after injection of Neovasculgen®
Time frame: 3 months and 6 months after the first injection of Neovasculgen®
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 28 Feb 2017.
- Background: PubMed 28050885Deev R, Plaksa I, Bozo I, Isaev A. Results of an International Postmarketing Surveillance Study of pl-VEGF165 Safety and Efficacy in 210 Patients with Peripheral Arterial Disease. Am J Cardiovasc Drugs. 2017 Jun;17(3):235-242. doi: 10.1007/s40256-016-0210-3.
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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.
Roman V Deev, MD study director
+7 495 646 80 76
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neovasculgen® in people with Lower Limb Ischemia, run by Artgen Biotech at 30 sites in Russia.
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 3 inclusion and 4 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Russia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in the measurement of pain-free walking distance (PWD) on treadmill (time frame: 3 months and 6 months after the first injection of Neovasculgen®.). 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 NCT02369809, 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 28 Feb 2017.