Peripheral Arterial DiseasePhase 2/3NeovasculgenNCT03068585
Efficiency, Safety and Portability of Neovasculgen
A Phase 2/3 study testing Neovasculgen (Cambiogeneplasmid) in people with Peripheral Arterial Disease, run by Artgen Biotech at 3 sites in Russia.
Trial summary
In 2010, we completed a phase 1 to 2a clinical trial of pCMV-vegf165 in patients with chronic lower limb ischemia (stage 2a to 3 according to Fontaine classification modified by A. V. Pokrovsky) who were not suitable for reconstructive surgery or endovascular treatment. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Neovasculgen (Cambiogeneplasmid)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesRussia
- Study dates
- Feb 2010to 1 Jul 2011
- Phase
- Phase 2/3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age more than 40 years;
- a history of stable claudication for at least 3 months;
- stage 2 to 3 chronic ischemia according to Fontaine classification (modified by A. V. Pokrovsky);
- presence of hemodynamically significant (stenosis >70% and/or occlusion) diffuse lesions of the interior and (or) posterior tibial arteries (distal lesion);
- voluntary informed consent signed and dated by the patient.
Who cannot join
- chronic lower limb ischemia of nonatherosclerotic genesis; stage 4 chronic ischemia according to Fontaine classification modified by A. V. Pokrovsky (ischemic ulcers and necrotic lesions);
- severe concomitant pathology with life expectancy <1 year;
- infectious diseases, history of cancer, or suspected malignancy;
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
Russian National Surgery Center by Petrovsky
Moscow, Central Russia, 119991
Ryazansky State Medical University
Ryazan, Central Russia, 390026
Yaroslavl State Medical Academy
Yaroslavl, Central Russia, 150000
About this study
Official title: Phase 3 Study of Efficiency, Safety and Portability of Gene Therapy Drug Neovasculgen (DNA Encoding the 165-amino-acid Isoform of Human Vascular Endothelial Growth Factor (pCMV - VEGF165) for Peripheral Arterial Disease Complex Treatment
In 2010, we completed a phase 1 to 2a clinical trial of pCMV-vegf165 in patients with chronic lower limb ischemia (stage 2a to 3 according to Fontaine classification modified by A. V. Pokrovsky) who were not suitable for reconstructive surgery or endovascular treatment. This study demonstrated the safety, feasibility, and short-term(3 months) efficacy of pCMV-vegf165 gene transfer,12,13which lead to conducting a phase 2b to 3 multicenter clinical trial. The study was conducted under the control of the Russian Ministry of Health and was completed in 2011. Patients enrolled in the study were subjected to a 6-month
Read the detailed description
We conducted a phase 2b/3 multicenter randomized controlled clinical trial of the intramuscular transfer of a plasmid DNA encoding vascular endothelial growth factor (VEGF) 165 with cytomegalovirus promotor (CMV) in patients with atherosclerotic lower limb ischemia. A total of 100 patients were enrolled in the study, that is, 75 patients were randomized into the test group and received 2 intramuscular injections of 1.2 mg of pCMV- vegf165, 14 days apart together with standard pharmacological treatment. In all, 25 patients were randomized into the control group and received standard treatment only. The following end points were evaluated within the first 6 months of the study and during a 1.5-year additional follow-up period: pain-free walking distance (PWD), ankle-brachial index (ABI), and blood flow velocity (BFV).
- Conditions
- Peripheral Arterial Disease
- Being tested
- Neovasculgen (Cambiogeneplasmid)
- Keywords
- PAD, CLI, stage 2a-3 of Pokrovsky-Fonteine
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neovasculgen (Cambiogeneplasmid)Drug
Also called Neovasculgen
treatment
| Study group | Role | What they receive |
|---|---|---|
| Neovasculgen | Experimental | DNA encoding the 165-amino-acid isoform of human vascular endothelial growth factor (pCMV - VEGF165) Receives: Drug: Neovasculgen (Cambiogeneplasmid) |
| Control | No intervention | Control therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-free walking distance.
The PWD was determined using a treadmill test with reduced initial speed (1 km/h), as the majority of elderly patients were unable to perform Gardner test or its equivalents.
Measured: 6 months
Secondary outcomes (3)
Ankle-brachial index
The ankle-brachial pressure index (ABPI) or ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). Compared to the arm, lower blood pressure in the leg is an indication of blocked arteries due to peripheral artery disease (PAD).
Measured: 6 months
Transcutaneous oximetry
Transcutaneous oximetry, tcpO2 or TCOM, is a local, non-invasive measurement reflecting the amount of O2 that has diffused from the capillaries, through the epidermis.
Measured: 6 months
quality of life
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients.
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 posted3 Mar 2017
- Study startFeb 2010
- Primary completion1 Jun 2011
- Study completion1 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artgen Biotech
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068585
- Sponsor's protocol ID
- NVG-IC
- Acronym
- Neovasculgen
- Status last verified
- Jun 2011
- First submitted
- 14 Jun 2011
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Deev RV, Bozo IY, Mzhavanadze ND, Voronov DA, Gavrilenko AV, Chervyakov YV, Staroverov IN, Kalinin RE, Shvalb PG, Isaev AA. pCMV-vegf165 Intramuscular Gene Transfer is an Effective Method of Treatment for Patients With Chronic Lower Limb Ischemia. J Cardiovasc Pharmacol Ther. 2015 Sep;20(5):473-82. doi: 10.1177/1074248415574336. Epub 2015 Mar 13.
PubMed 25770117Deev R, Plaksa I, Bozo I, Mzhavanadze N, Suchkov I, Chervyakov Y, Staroverov I, Kalinin R, Isaev A. Results of 5-year follow-up study in patients with peripheral artery disease treated with PL-VEGF165 for intermittent claudication. Ther Adv Cardiovasc Dis. 2018 Sep;12(9):237-246. doi: 10.1177/1753944718786926. Epub 2018 Jul 11.
PubMed 29996720
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Efficiency, Safety and Portability of Gene Therapy Drug Neovasculgen (DNA Encoding the 165-amino-acid Isoform of Human Vascular Endothelial Growth Factor (pCMV - VEGF165) for Peripheral Arterial Disease Complex Treatment
- ClinicalTrials.gov ID
- NCT03068585
- Acronym / sponsor ID
- Neovasculgen / NVG-IC
- Conditions
- Peripheral Arterial Disease
- Keywords
- PAD, CLI, stage 2a-3 of Pokrovsky-Fonteine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Artgen BiotechUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- 1 Jun 2011 (actual)
- Study completion
- 1 Jul 2011 (actual)
- First posted
- 3 Mar 2017 (actual)
- 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.
In 2010, we completed a phase 1 to 2a clinical trial of pCMV-vegf165 in patients with chronic lower limb ischemia (stage 2a to 3 according to Fontaine classification modified by A. V. Pokrovsky) who were not suitable for reconstructive surgery or endovascular treatment. This study demonstrated the safety, feasibility, and short-term(3 months) efficacy of pCMV-vegf165 gene transfer,12,13which lead to conducting a phase 2b to 3 multicenter clinical trial. The study was conducted under the control of the Russian Ministry of Health and was completed in 2011. Patients enrolled in the study were subjected to a 6-month
Detailed description
We conducted a phase 2b/3 multicenter randomized controlled clinical trial of the intramuscular transfer of a plasmid DNA encoding vascular endothelial growth factor (VEGF) 165 with cytomegalovirus promotor (CMV) in patients with atherosclerotic lower limb ischemia. A total of 100 patients were enrolled in the study, that is, 75 patients were randomized into the test group and received 2 intramuscular injections of 1.2 mg of pCMV- vegf165, 14 days apart together with standard pharmacological treatment. In all, 25 patients were randomized into the control group and received standard treatment only. The following end points were evaluated within the first 6 months of the study and during a 1.5-year additional follow-up period: pain-free walking distance (PWD), ankle-brachial index (ABI), and blood flow velocity (BFV).
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 (Cambiogeneplasmid)DNA encoding the 165-amino-acid isoform of human vascular endothelial growth factor (pCMV - VEGF165) |
| Control | No intervention | –Control therapy |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age more than 40 years;
- a history of stable claudication for at least 3 months;
- stage 2 to 3 chronic ischemia according to Fontaine classification (modified by A. V. Pokrovsky);
- presence of hemodynamically significant (stenosis >70% and/or occlusion) diffuse lesions of the interior and (or) posterior tibial arteries (distal lesion);
- voluntary informed consent signed and dated by the patient.
Key exclusion criteria (3 listed)
- chronic lower limb ischemia of nonatherosclerotic genesis; stage 4 chronic ischemia according to Fontaine classification modified by A. V. Pokrovsky (ischemic ulcers and necrotic lesions);
- severe concomitant pathology with life expectancy <1 year;
- infectious diseases, history of cancer, or suspected malignancy;
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 (Cambiogeneplasmid)Also: Neovasculgentreatment | Drug | Neovasculgen |
Primary outcome
Pain-free walking distance.
Time frame: 6 months
The PWD was determined using a treadmill test with reduced initial speed (1 km/h), as the majority of elderly patients were unable to perform Gardner test or its equivalents.
3 secondary outcomes
Ankle-brachial index
Time frame: 6 months
Transcutaneous oximetry
Time frame: 6 months
quality of life
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 3 Mar 2017.
- Results publication: PubMed 25770117Deev RV, Bozo IY, Mzhavanadze ND, Voronov DA, Gavrilenko AV, Chervyakov YV, Staroverov IN, Kalinin RE, Shvalb PG, Isaev AA. pCMV-vegf165 Intramuscular Gene Transfer is an Effective Method of Treatment for Patients With Chronic Lower Limb Ischemia. J Cardiovasc Pharmacol Ther. 2015 Sep;20(5):473-82. doi: 10.1177/1074248415574336. Epub 2015 Mar 13.
- Derived from this study: PubMed 29996720Deev R, Plaksa I, Bozo I, Mzhavanadze N, Suchkov I, Chervyakov Y, Staroverov I, Kalinin R, Isaev A. Results of 5-year follow-up study in patients with peripheral artery disease treated with PL-VEGF165 for intermittent claudication. Ther Adv Cardiovasc Dis. 2018 Sep;12(9):237-246. doi: 10.1177/1753944718786926. Epub 2018 Jul 11.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Neovasculgen (Cambiogeneplasmid) in people with Peripheral Arterial Disease, run by Artgen Biotech at 3 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 5 inclusion and 3 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pain-free walking distance. (time frame: 6 months). 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 NCT03068585, which also lists 2 linked publications.
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 3 Mar 2017.