Tenecteplase (TNK) for Loculated Pleural Effusions in Patients With Malignancy

NCT01580618 | Terminated Phase 2 Results

• 1 other identifier: HI-07HYoon-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to determine the safety and efficacy of TNK infusion for the treatment of loculated pleural effusions in patients with known malignancy compared to normal saline infusion.

Conditions

Pleural Effusion

Keywords

pleural effusion; malignancy; loculated

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients Achieving Complete or Near Complete Drainage of Loculated Pleural Effusion as Determined From Chest Radiography After Three Days or Five Days of Intrapleural Therapy.

  3-5 days

• Percentage of Patients With Hemorrhagic Complications Associated With Catheter Drainage

  This is the percentage of patients in each arm of the study (Normal saline or TNKase) who suffered a hemorrhagic complication directly associated with instillation of normal saline or TNKase

  3-5 days

Secondary Outcomes (3)

• Percentage of Patients Who Fail Initial Therapy (TNK or Saline) Who at the Request of the Hospital-based Doctor Are Then Switched to the Other Arm/Group AND Who Then Achieve Satisfactory Drainage (Saline or TNK) Therapy.

  3-5 days

• Percentage of Patients Able to Undergo Pleurodesis to Prevent Recurrent Pleural Effusion.

  30 days

• Duration of Hospital Stay From the Time of Initiation of Infusion Therapy for the Loculated Effusion

  30 days

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

Loculated pleural effusion infused with normal saline twice a day for three days.

Drug: normal saline

TNKase

ACTIVE COMPARATOR

Loculated pleural effusion infused with TNK twice a day for three days.

Drug: TNK (Tenecteplase)

Interventions

normal saline DRUG

Injection of 60 ml normal saline twice a day for three days using the existing chest tube.

Normal Saline

TNK (Tenecteplase) DRUG

Injection of 4 mg of TNK with 59 ml normal saline into the existing chest tube twice a day for three days.

Also known as: TNKase, tenecteplase

TNKase

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.
• Age \> 18 years
• Adult, non-gravid patients with malignancy and symptomatic loculated pleural effusion who has undergone percutaneous drainage will be eligible to participate. A loculated effusion is defined as an effusion whose contents cannot be completely drained at the time of initial catheter placement as documented by the initial imaging guided procedure or within 48 hours of catheter placement by chest radiography. Malignant cells need not be found within the pleural fluid.

You may not qualify if:

• Active internal bleeding, involving intracranial and retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts
• History of stroke within 3 months
• Intracranial neoplasm, arteriovenous malformation, or aneurysm.
• Uncorrectable bleeding diathesis (INR \> 1.5 despite therapy)
• Recent intracranial or intraspinal surgery or trauma
• Pregnancy (positive pregnancy test)
• Severe uncontrolled hypertension
• Documented empyema
• Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
• Participation in another simultaneous medical investigation or trial
• Participation in another clinical investigation within previous 30 days of catheter placement
• Prior enrollment in the study
• Known allergy to TNK or any of its components

Sponsors & Collaborators

• Kaiser Permanente: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Kaiser Foundation Hospital

Honolulu, Hawaii, 96819, United States

Location

MeSH Terms

Conditions

Pleural Effusion; Neoplasms

Interventions

Saline Solution; Tenecteplase

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Results are limited due to the small numbers of patients enrolled

Results Point of Contact

• Title: Hyo-Chun Yoon, MD, PHD
• Organization: Kaiser Permanente

Hyo-Chun.Yoon@nsmtp.kp.org

8084327342

Study Officials

• Hyo-Chun Yoon, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Radiologist

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: April 19, 2012
• Study Start: January 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 14, 2026
• Results First Posted: January 6, 2015

Record last verified: 2026-04

Locations

US (1)