Moderate to Severe Angina PectorisPhase 2NCT00215696
A Study to Treat Patients Whose Chronic Angina Symptoms Are Not Relieved by Medication and Have an Area of the Heart That Cannot be Treated by Standard Therapies
A Phase 2 study testing BioBypass® in people with Moderate to Severe Angina Pectoris, run by GenVec at 3 sites in 2 countries.
Trial summary
The primary purpose of this study is to determine whether treatment with an experimental gene therapy (BIOBYPASS®) will reduce angina in study participants by stimulating the growth of new blood vessels. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Moderate to Severe Angina Pectoris
- What is being tested?
- BioBypass®
- How many people
- 129 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Apr 2005to not given
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years and less than or equal to 80 years;
- Written informed consent obtained prior to any study dictated procedure;
- Moderate to severe angina (CCS Angina Class II-IV) despite optimal medical therapy;
- Treated with optimal unchanged antianginal medical therapy for at least 2 months prior to the first baseline ETT. Optimal medical therapy must include the following medications (unless hemodynamic parameters or intolerance contraindicate their use):
- Nitroglycerine;
- Antianginal medications: Long-acting nitrates, calcium-channel blockers, potassium channel opener and beta-blockers (Note: All participants are required to be on at least 2 of the 4 antianginal medications listed above);
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- Platelet aggregation inhibitor (e.g., aspirin, ticlopidine, or clopidogrel)
- ACE inhibitor
- Statin (HMG-CoA Reductase Inhibitor)
- The participant must have, within 3 months prior to randomization, documented coronary angiographic evidence of significant 2- or 3- vessel disease, or equivalent disease in one dominant artery, and at least one remaining larger coronary vessel from which new collaterals/vessels could be supplied.
- Any participant who has undergone CABG or PCI within 6 months of entry must have angiography performed within 1 month prior to entry, and at least 4 months after the previous intervention to rule out early restenosis.
- Candidates must not be eligible for any other re-vascularization procedures. The participant and his coronary film must have been discussed with an independent cardiac surgeon and must have been denied for CABG or PTCA. Participants who are marginal or poor candidates for conventional revascularization will be considered eligible if the risks of performing a CABG or PTCA procedure outweigh the potential benefit and/or such a procedure is unlikely to offer a worthwhile clinical benefit. The criteria defining such cases may include, but may not be limited to, the following examples:
- Diffuse or distal vessel disease
- Chronic occlusions
- Unprotected left main stenosis
- Tortuous or severely angulated vessels
- Severely calcified vessels
- Small vessels (< 2.5mm)
- Two baseline bicycle ergometry exercise tolerance tests (ETTs) performed meeting the following criteria:
- Able to exercise for a minimum duration of 2 minutes and no more than 8 minutes
- Exercise duration on the two ETTs must be within 15% of each other. (The second test will be used for the baseline value. In the event of excessive variability, a third test may be performed and the participant may be enrolled if exercise duration on the third test is within 15% of either prior test. In this case, the third test will be used as the baseline value.)
- ETTs must not be discontinued for any reason other than ETT Angina Level 3
- Note: Participant must NOT be informed of exercise restrictions required for entry.
- Significant reversible myocardial ischemia on a single photon emission computer tomography (SPECT). Judgment will be made by an independent core lab. The size of the reversible defect must be > 10 % of left ventricle.
- Ventricular wall thickness of the treatment zone > 8mm as per baseline echocardiogram.
Who cannot join
- Pregnant or lactating women. It is required that both men and women use condoms or another barrier method of birth control for at least 8 weeks following administration of BIOBYPASS® and some form of birth control for at least one year;
- Clinically significant anemia (e.g. hematocrit < 36% or hemoglobin < 12 g/dL for men and < 11 g/dL for women), leukopenia (WBC<3,000/µL), leukocytosis (WBC > 12,000), or thrombocytopenia (platelet count < 100,000 billion/l);
- Abnormal prothrombin or partial thromboplastin time or anticoagulant therapy that cannot be withheld for treatment;
- Significant renal dysfunction (serum creatinine > 1.6 mg/dL);
- Hepatic dysfunction (AST/ALT must be within normal limits);
- Hematuria, unless of known, non-malignant etiology (any unexplained hematuria would require the candidate to be excluded);
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- Uncontrolled hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg) or significant hypotension (systolic blood pressure <90 mmHg);
- Conditions other than angina that will limit exercise test (e.g. severe peripheral vascular disease, COPD);
- Ophthalmologic conditions pertinent to proliferative retinopathy or conditions that preclude standard ophthalmologic examination.
- Cataract surgery within 6 months of trial;
- Vascular lesions of the anterior segment of the eye (infection or ulceration of the cornea, rubeotic glaucoma, etc);
- Vascular lesions of the posterior segment of the eye or proliferative retinopathy in diabetics, macular edema, s/p photocoagulation for macular edema or proliferative retinopathy; nondiabetics with central or branch retinal vascular occlusions, sickle cell retinopathy, ischemic retinopathy due to retinal venous stasis or carotid artery disease);
- Choroidal new vessels associated with age-related macular degeneration, myopic degeneration, presumed ocular histoplasmosis syndrome, angioid streaks, pseudoxanthoma elasticum, or without ocular disease; and
- Large elevated choroidal nevi, choroidal vascular tumors (choroidal hemangioma), or melanomas.
- Any acute illness within one week of the start of the study or any other illness considered by the Investigator to significantly interfere with study outcome;
- Clinical evidence of active infection of any type, including adenovirus (evidenced by a screening adenovirus neutralizing antibody titer of > 1:50);
- Immunocompromised status (in the investigator's opinion) or currently receiving immunosuppressive therapy;
- Left ventricular ejection fraction < 25% as measured by LV angiography.
- Congestive heart failure NYHA class III-IV;
- Valvular heart disease requiring surgical intervention or hemodynamically significant aortic valve disease;
- Recent (less than 6 weeks prior to screening) Acute Coronary Syndrome with increase in CK-MB or Troponins/PCI/CABG/Stroke or TIA;
- History of malignancy (except cured non-melanoma skin cancer) or suspicion of current malignancy;
- Known allergy to the diluent used to suspend the virus;
- Other experimental medications within the last four weeks prior to the second baseline ETT;
- Revascularization procedure (percutaneous coronary intervention or coronary artery bypass) within 4 months of Day 1.
- Participants who have previously received VEGF or any other angiogenic agent or gene therapy in the past, or who have participated in other investigational studies within the last year if the endpoints are overlapping.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Denmark2 sites
Skejby Sygehus, Caridology Laboratory
Århus N, DK-8200
Cardiovascular Laboratory 2014, The Heart Center, University hospital Rigshospitalet
Copenhagen, 2100
Israel1 site
Cardiac Catheterization Laboratories, Cardiology Department, Rabin Medical Center
Petah, Tikva, 49100
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of BIOBYPASS® (ADGVVEGF121.10NH) Delivered by NOGA™-GUIDED/MYOSTAR™ Catheter in "No Option" Patients With Class II-IV Stable Angina
The primary purpose of this study is to determine whether treatment with an experimental gene therapy (BIOBYPASS®) will reduce angina in study participants by stimulating the growth of new blood vessels. This will be measured by testing whether participants are able to exercise longer without experiencing angina after treatment, as compared to before treatment.
Additionally, this study will collect information about any side effects that might be related to the treatment with the experimental therapy.
- Conditions
- Moderate to Severe Angina Pectoris
- Being tested
- BioBypass®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioBypass®Genetic
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total exercise duration on exercise tolerance test (ETT, using the bicycle ergometry test protocol) at week 26.
Secondary outcomes (8)
Change of reversible perfusion defect size in SPECT perfusion study at week 26
Total exercise duration at weeks 12 and 52
Time-to-onset of 1mm ST depression on ETT at weeks 12, 26, 52
Peak rate-pressure product and maximal workload (in METS) during ETT at weeks 12, 26, 52
CCS class at weeks 12, 26, 52
Frequency of angina attacks at weeks 12, 26, 52
Nitroglycerine consumption at weeks 12, 26, 52
Results of Seattle angina questionnaire at weeks 12, 26, 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Angina PectorisStudies 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
- Single group
- Masking
- Double blind
- Enrolment
- 129 participants
Sponsor and investigators
- Lead sponsor
- GenVec
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr. Jens Kastrup, Principal investigator, The Heart Center, University hospital Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215696
- Sponsor's protocol ID
- GV-002.001
- Status last verified
- May 2011
- First submitted
- 15 Sep 2005
- Last updated
- 13 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of BIOBYPASS® (ADGVVEGF121.10NH) Delivered by NOGA™-GUIDED/MYOSTAR™ Catheter in "No Option" Patients With Class II-IV Stable Angina
- ClinicalTrials.gov ID
- NCT00215696
- Acronym / sponsor ID
- GV-002.001
- Conditions
- Moderate to Severe Angina Pectoris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants
- Lead sponsor
- GenVecIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- First posted
- 22 Sep 2005 (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.
The primary purpose of this study is to determine whether treatment with an experimental gene therapy (BIOBYPASS®) will reduce angina in study participants by stimulating the growth of new blood vessels. This will be measured by testing whether participants are able to exercise longer without experiencing angina after treatment, as compared to before treatment.
Additionally, this study will collect information about any side effects that might be related to the treatment with the experimental therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Age greater than or equal to 18 years and less than or equal to 80 years;
- Written informed consent obtained prior to any study dictated procedure;
- Moderate to severe angina (CCS Angina Class II-IV) despite optimal medical therapy;
- Treated with optimal unchanged antianginal medical therapy for at least 2 months prior to the first baseline ETT. Optimal medical therapy must include the following medications (unless hemodynamic parameters or intolerance contraindicate their use):
- The participant must have, within 3 months prior to randomization, documented coronary angiographic evidence of significant 2- or 3- vessel disease, or equivalent disease in one dominant artery, and at least one remaining larger coronary vessel from which new collaterals/vessels could be supplied.
Key exclusion criteria (26 listed)
- Pregnant or lactating women. It is required that both men and women use condoms or another barrier method of birth control for at least 8 weeks following administration of BIOBYPASS® and some form of birth control for at least one year;
- Clinically significant anemia (e.g. hematocrit < 36% or hemoglobin < 12 g/dL for men and < 11 g/dL for women), leukopenia (WBC<3,000/µL), leukocytosis (WBC > 12,000), or thrombocytopenia (platelet count < 100,000 billion/l);
- Abnormal prothrombin or partial thromboplastin time or anticoagulant therapy that cannot be withheld for treatment;
- Significant renal dysfunction (serum creatinine > 1.6 mg/dL);
- Hepatic dysfunction (AST/ALT must be within normal limits);
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 |
|---|---|---|
| BioBypass® | Genetic | – |
Primary outcome
Change from baseline in total exercise duration on exercise tolerance test (ETT, using the bicycle ergometry test protocol) at week 26.
8 secondary outcomes
Change of reversible perfusion defect size in SPECT perfusion study at week 26
Total exercise duration at weeks 12 and 52
Time-to-onset of 1mm ST depression on ETT at weeks 12, 26, 52
Peak rate-pressure product and maximal workload (in METS) during ETT at weeks 12, 26, 52
CCS class at weeks 12, 26, 52
Frequency of angina attacks at weeks 12, 26, 52
Nitroglycerine consumption at weeks 12, 26, 52
Results of Seattle angina questionnaire at weeks 12, 26, 52
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 13 May 2011.
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.
Dr. Jens Kastrup principal investigator
The Heart Center, University hospital Rigshospitalet
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BioBypass® in people with Moderate to Severe Angina Pectoris, run by GenVec at 3 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 25 inclusion and 26 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 13 May 2011. 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 Denmark, Israel. 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?
Change from baseline in total exercise duration on exercise tolerance test (ETT, using the bicycle ergometry test protocol) at week 26.. 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 13 May 2011.