Tenecteplase (TNK) in the Treatment of Intracerebral Hemorrhage (ICH)

NCT06696131 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: Pro2024001604
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

Brief Summary

The overall purpose of this study is to look at the safety and effectiveness of administering Tenecteplase (TNK) into the brain bleed (hematoma) instead of another clot-dissolving drug known as recombinant tissue plasminogen activator (rtPA), which is the current standard practice. Clot dissolving (Fibrinolytic) drugs work to break down blood clots and have been found to improve health outcomes when applied directly into the hematoma within the brain. Patients who take part in this study will undergo the same surgical procedure that would normally be performed to treat them, but with the exception of TNK not rtPA.

Conditions

Intracranial Hemorrhages; Hemorrhagic Strokes; Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (2)

• Safety Assessment

  To assess the safety of 0.25 mg TNKase (single dose) administered directly into the hematoma via a soft brain catheter in patients with ICH.

  From treatment until follow-up date (+/- 30 days)

• Adverse Event Evaluation

  To evaluate the incidence and severity of adverse events, such as rehemorrhage, infection, mortality at 30 days following the administration of TNKase.

  From treatment until follow-up date (+/- 30 days)

Secondary Outcomes (1)

• Radiological Assessment of the Hematoma Resolution

  From treatment until follow-up date (+/- 30 days)

Study Arms (1)

TNK

EXPERIMENTAL

Participants would be given TNK through a brain catheter to dissolve an intracerebral blood clot after a hemorrhage.

Drug: TNK

Interventions

TNK DRUG

TNK will be delivered into the site of the intracerebral hemorrhage via a brain catheter.

TNK

Eligibility Criteria

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

You may qualify if:

• Patient/legally authorized representative has signed the Informed Consent Form.
• Ability to comply with the study protocol, in the investigator's judgment.
• Patients 18 to 80 years of age with an ICH had occurred within 24 hours before admission.
• Spontaneous supratentorial (basal ganglia, thalamus, lobar) ICH ≥30 mL measured utilizing the ABC/2 method.
• Subjects with a GCS score of 5-14.
• NIHSS ≥6.
• Stability CT scan done at least 6 hours after baseline CT showing clot stability (growth \<5 mL as measured by ABC/2 method). If the hematoma volume measured on the stability CT scan increases by 5 mL or more, a second stability CT scan will be performed 12 hours later.
• Sustained systolic blood pressure (SBP) \<180 mm Hg for six hours recorded closest to the time of drug administration.
• Symptoms must be present less than 24 hours prior to baseline CT scan.
• Baseline Rankin score of 0 or 1.

You may not qualify if:

• Presence of infratentorial parenchymal bleeding.
• Presence of a hemorrhage extending to the midbrain.
• An unknown time of onset or the symptoms onset more than 24 hours prior to admission.
• Pregnancy.
• Inability to obtain written informed consent from subject or legal representative.
• Sustained SBP \>180 mm Hg for six hours recorded closest to the time of drug administration.
• Age \<18 and \>80 years.
• Radiological evidence of arterio-venous malformation, aneurysm, amyloid angiopathy, Moyamoya disease, hemorrhagic conversion of an ischemic stroke, recurrent hemorrhage in the same location within the past 365 year or unstable mass as a source for the ICH.
• Evidence of coagulopathy (international normalized ratio \>1.3; platelet count \<100 ,000 or platelet dysfunction P2Y-12 \>250) or known clotting disorder.
• Bilateral fixed, dilated pupils indicating irreversible impaired brain stem function with GCS ≤4.
• Patients with severe ICH and IVH who require an external ventricular drain (EVD) placement for cerebrospinal fluid (CSF) diversion or separate intraventricular thrombolysis.
• Inability to maintain INR less than 1.3.
• Use of anticoagulants prior to symptom onset and subjects requiring long-term anticoagulants (the reversal is permitted if the patient can tolerate the short-term risk of reversal).
• Use of Dabigatran, Apixaban, and/or Rivaroxaban (or a similar medication from the similar medication class) prior to symptom onset.
• Internal bleeding (GI, renal, respiratory etc).

Sponsors & Collaborators

• Genentech, Inc.: collaborator
• Gaurav Gupta, MD: lead

MeSH Terms

Conditions

Cerebral Hemorrhage; Intracranial Hemorrhages; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke

Study Officials

• Gaurav Gupta, MD

  Rutgers University, RWJ Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine N Yohn, Ph D

CONTACT

908-328-4210; cy253@rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator; Professor | Department of Neurosurgery, RWJMS System Co-Director, Cerebrovascular & Endovascular Neurosurgery

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 20, 2024
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share