Carotid StenosisPhase 2NCT00904254
The Use of Anti-CD4 mAb-Fragment for Imaging of Local Inflammation in Patients With Carotid Artery Stenosis
A Phase 2 study testing EP 1645/Solution For Injection, 99mTC in people with Carotid Stenosis, run by Technische Universität Dresden.
Trial summary
The primary objective of this study is to proof the concept of EP 1645 as a diagnostic tool for carotid artery atherosclerosis and plaque instability and to assess the safety and tolerability of this diagnostic agent, a monoclonal antibody fragment (Fab') conjugated with the diagnostic radionuclide 99mTc. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- EP 1645/Solution For Injection, 99mTC
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2016
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female with either symptomatic (> 60%) or asymptomatic (> 80%) carotid artery stenosis between 50 and 80 years of age
- Symptomatic stenosis of the A. carotis interna is defined as occurence of focal ischemic symptoms in the area of the supplying vessel, occurence of a transischemic attack (TIA), occurence of focal neurologic dysfunction or unilateral blindness.
- informed consent in accordance with ICH GCP and § 40 AMG and StrahlSchV
- sonography status from the patient is present (printout is available)
- patients available for carotid surgery within 3 months after diagnosis of carotid artery stenosis
- In patients with bilateral disease, only the stenosis considered for surgery will be included in the endpoint evaluation.
Who cannot join
- patients > 80 years
- major disease of the cardiovascular system, respiratory system, hepatobiliary system or CNS, which prevents patients from the study participation as to the opinion of the investigator
- hepatic (transaminases > 3 x norm) or renal (serum creatinine increase > 2x norm) insufficiency
- regular drug intake of biologics. Intake of all other drugs must be judged by investigator and must be the strictly documented
- previous administration of xenogenous proteins
- history of anaphylactic reaction to any drug administered by a parenteral pathway
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- previous participation in a radiopharmaceutical drug trial (unless the effective dose acquired by participation in the current trial will remain below 10 mSv)
- participation in any clinical drug trial within 3 months prior to enrolment
- women of child-bearing potential (child-bearing potential to be ruled out by one of the following: at least 2 years past menopause, hysterectomy, bilateral oophorectomy, bilateral tubal ligation)
- Patients presenting clinical signs of severe systemic infection (CRP > 50 mg/dl)
- Carotid Surgery (TEA) not possible within a time frame of 7 days after imaging
- Patients with bilateral carotid stenosis if clinically regarded as critical by the angiologists.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Use of Anti-CD4 mAb-Fragment for Imaging of Local Inflammation in Patients With Asymptomatic and Symptomatic Carotid Artery Stenosis - an Open Proof of Concept Study.
The primary objective of this study is to proof the concept of EP 1645 as a diagnostic tool for carotid artery atherosclerosis and plaque instability and to assess the safety and tolerability of this diagnostic agent, a monoclonal antibody fragment (Fab') conjugated with the diagnostic radionuclide 99mTc. Safety and tolerability will be determined by adverse events (AEs) observed and reported upon administration of the product and the absorbed dose of radiation.
Read the detailed description
For the evaluation of atherosclerosis in carotid arteries up to now sonographic measurements of plaque burden are used. This method has advantages for investigation of carotid arteries since this region is easy accessible for this investigation. However, it does not allow evaluation of the vessels which are remote from the body surface, as, for instance, coronary arteries. A method for non-invasive reliable evaluation of such arteries is needed. Also the distinction between vulnerable and stable plaque has a great clinical relevance. A quantifiable method for the determination of the effects of new therapeutic approaches would be highly appreciated.
It is expected, that the new antibody fragment with its radioactive linkage will allow displaying an image of the activity distribution of the disease. Due to the fact that only patients with atherosclerotic changes in carotid arteries allow comparing the activity and the clinical signs of disease, this proof of concept study (phase II study) will be performed in patients with asymptomatic and symptomatic carotid artery stenosis.
- Conditions
- Carotid Stenosis
- Being tested
- EP 1645/Solution For Injection, 99mTC
- Keywords
- cerebrovascular disorders, symptomatic carotid artery stenosis, asymptomatic carotid artery stenosis, monoclonal antibody, diagnostics, molecular target, immunoglobulin Fab fragments, physiological effects of drugs, Tc99m-pertechnetate, Fab-fragment of Anti-human CD4, Antibodies, Monoclonal, Antibodies
- Medical subject headings
- Carotid Stenosis, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP 1645/Solution For Injection, 99mTCRadiation
Also called CD4 Antibody
(Fab-fragment of Anti-human CD4,technetium-99m)
| Study group | Role | What they receive |
|---|---|---|
| 1, diagnostic comparison | Experimental | EP 1645/Solution For Injection Receives: Radiation: EP 1645/Solution For Injection, 99mTC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scintigraphic confirmation of clinical disease
8 patients with stable atherosclerosis will be assigned to study group 1 and 8 patients with instable atherosclerosis will be assigned to study group 2. It is expected that the study substance enriches only in carotid arteries of patients assigned to study group 2 and not in lesions of patients assigned to group 1. The study results of this proof-of-concept-study will be compared purely with descriptive methods in order to create a consistent set data which can be used for a valid case number estimation for a future phase II trial.
Measured: A total of 16 patients will be recruited for this study.
Secondary outcomes (1)
Adverse events (signs and symptoms), laboratory tests.
Measured: during the entire study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startJan 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid StenosisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Chemnitz gGmbH
- Responsible party
- Sponsor
- Investigators
- Christoph Schindler Schindler, MD, Principal investigator, Institute of Clinical Pharmacology, Medical Faculty, Technical University Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904254
- Sponsor's protocol ID
- TUD-Athero-040
- Other IDs
- 2008-008443-14, 2008
- Status last verified
- Feb 2012
- First submitted
- 18 May 2009
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Anti-CD4 mAb-Fragment for Imaging of Local Inflammation in Patients With Asymptomatic and Symptomatic Carotid Artery Stenosis - an Open Proof of Concept Study.
- ClinicalTrials.gov ID
- NCT00904254
- Acronym / sponsor ID
- TUD-Athero-040
- Conditions
- Carotid Stenosis
- Keywords
- cerebrovascular disorders, symptomatic carotid artery stenosis, asymptomatic carotid artery stenosis, monoclonal antibody, diagnostics, molecular target, immunoglobulin Fab fragments, physiological effects of drugs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Klinikum Chemnitz gGmbH
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 19 May 2009 (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 objective of this study is to proof the concept of EP 1645 as a diagnostic tool for carotid artery atherosclerosis and plaque instability and to assess the safety and tolerability of this diagnostic agent, a monoclonal antibody fragment (Fab') conjugated with the diagnostic radionuclide 99mTc. Safety and tolerability will be determined by adverse events (AEs) observed and reported upon administration of the product and the absorbed dose of radiation.
Detailed description
For the evaluation of atherosclerosis in carotid arteries up to now sonographic measurements of plaque burden are used. This method has advantages for investigation of carotid arteries since this region is easy accessible for this investigation. However, it does not allow evaluation of the vessels which are remote from the body surface, as, for instance, coronary arteries. A method for non-invasive reliable evaluation of such arteries is needed. Also the distinction between vulnerable and stable plaque has a great clinical relevance. A quantifiable method for the determination of the effects of new therapeutic approaches would be highly appreciated.
It is expected, that the new antibody fragment with its radioactive linkage will allow displaying an image of the activity distribution of the disease. Due to the fact that only patients with atherosclerotic changes in carotid arteries allow comparing the activity and the clinical signs of disease, this proof of concept study (phase II study) will be performed in patients with asymptomatic and symptomatic carotid artery stenosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1, diagnostic comparison | Experimental | Radiation: EP 1645/Solution For Injection, 99mTCEP 1645/Solution For Injection |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- male and female with either symptomatic (> 60%) or asymptomatic (> 80%) carotid artery stenosis between 50 and 80 years of age
- Symptomatic stenosis of the A. carotis interna is defined as occurence of focal ischemic symptoms in the area of the supplying vessel, occurence of a transischemic attack (TIA), occurence of focal neurologic dysfunction or unilateral blindness.
- informed consent in accordance with ICH GCP and § 40 AMG and StrahlSchV
- sonography status from the patient is present (printout is available)
- patients available for carotid surgery within 3 months after diagnosis of carotid artery stenosis
Key exclusion criteria (12 listed)
- patients > 80 years
- major disease of the cardiovascular system, respiratory system, hepatobiliary system or CNS, which prevents patients from the study participation as to the opinion of the investigator
- hepatic (transaminases > 3 x norm) or renal (serum creatinine increase > 2x norm) insufficiency
- regular drug intake of biologics. Intake of all other drugs must be judged by investigator and must be the strictly documented
- previous administration of xenogenous proteins
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 |
|---|---|---|
| EP 1645/Solution For Injection, 99mTCAlso: CD4 Antibody(Fab-fragment of Anti-human CD4,technetium-99m) | Radiation | 1, diagnostic comparison |
Primary outcome
Scintigraphic confirmation of clinical disease
Time frame: A total of 16 patients will be recruited for this study.
8 patients with stable atherosclerosis will be assigned to study group 1 and 8 patients with instable atherosclerosis will be assigned to study group 2. It is expected that the study substance enriches only in carotid arteries of patients assigned to study group 2 and not in lesions of patients assigned to group 1. The study results of this proof-of-concept-study will be compared purely with descriptive methods in order to create a consistent set data which can be used for a valid case number estimation for a future phase II trial.
1 secondary outcome
Adverse events (signs and symptoms), laboratory tests.
Time frame: during the entire study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
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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.
Christoph Schindler Schindler, MD principal investigator
Institute of Clinical Pharmacology, Medical Faculty, Technical University Dresden
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EP 1645/Solution For Injection, 99mTC in people with Carotid Stenosis, run by Technische Universität Dresden.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joachim Siegert, MD, PhD (+49 351 458 5694, joachim.siegert@mailbox.tu-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scintigraphic confirmation of clinical disease (time frame: A total of 16 patients will be recruited for this study.). 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 3 Feb 2012.