The Use of Anti-CD4 mAb-Fragment for Imaging of Local Inflammation in Patients With Carotid Artery Stenosis

NCT00904254 | Unknown Phase 2 DMC

• 2 other identifiers: TUD-Athero-0402008-008443-14
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief 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. Safety and tolerability will be determined by adverse events (AEs) observed and reported upon administration of the product and the absorbed dose of radiation.

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; Tc99m-pertechnetate; Fab-fragment of Anti-human CD4; Antibodies, Monoclonal; Antibodies

Outcome Measures

Primary Outcomes (1)

• 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.

  A total of 16 patients will be recruited for this study.

Secondary Outcomes (1)

• Adverse events (signs and symptoms), laboratory tests.

  during the entire study

Study Arms (1)

1, diagnostic comparison

EXPERIMENTAL

EP 1645/Solution For Injection

Radiation: EP 1645/Solution For Injection, 99mTC

Interventions

EP 1645/Solution For Injection, 99mTC RADIATION

(Fab-fragment of Anti-human CD4,technetium-99m)

Also known as: CD4 Antibody

1, diagnostic comparison

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Technische Universität Dresden: lead
• Klinikum Chemnitz gGmbH: collaborator

MeSH Terms

Conditions

Carotid Stenosis; Cerebrovascular Disorders

Interventions

Injections

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Christoph Schindler Schindler, MD

  Institute of Clinical Pharmacology, Medical Faculty, Technical University Dresden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joachim Siegert, MD, PhD

CONTACT

+49 351 458 5694; joachim.siegert@mailbox.tu-dresden.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 19, 2009
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 3, 2012

Record last verified: 2012-02