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WithdrawnNCT04281524Updated Mar 25, 2020

A Clinical Study to Test the Efficacy and Safety of CSL312 on Catheter-associated Blood Clot Formation in Subjects With Cancer Who Receive Chemotherapy Through a PICC Line

A Phase 1/2 interventional study of CSL312 and Placebo in PICC-associated Thrombosis, sponsored by CSL Behring. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-25.

Sponsored by CSL Behring · Phase 1/2, Interventional, and Prevention

Why this study was withdrawn
Business decision non-safety related.
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Peripherally Inserted Central Catheters (PICCs) are commonly used in patients with cancer to administer chemotherapy and supportive care medication. However, PICCs and other medical devices that come into contact with blood increase the risk of blood clots (thrombosis) inside the blood vessels. Conventional blood thinners (anticoagulants) may reduce the risk of thrombosis but they also increase the risk of bleeding. CSL312, a monoclonal antibody that inhibits the activated blood clotting factor 12 (FXIIa) will be assessed for its potential to prevent thrombus formation in subjects with cancer at risk of PICC-associated thrombosis.

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Conditions studied

  • PICC-associated Thrombosis

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03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

Browse Thrombosis studies →

Lead sponsor

CSL Behring is the lead sponsor of 142 studies on the registry; 18 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged 18 years or older at the time of providing written informed consent
  • Diagnosis of malignancy that requires placement of a PICC within the next 3 weeks for administration of chemotherapy (PICC anticipated to be required for at least 1 month)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 [Oken et al, 1982], and investigator's expectation that performance status will remain 0, 1, or 2 for the duration of the study

Exclusion criteria

Exclusion Criteria:

  • Active bleeding or with a current clinically significant coagulopathy (eg, international normalized ratio [INR] > 1.5) or clinically significant risk for bleeding (eg, recent intracranial hemorrhage or bleeding peptic ulcer within the last 4 weeks)
  • History of venous thrombosis, myocardial infarction or cerebrovascular event within 3 months, or a prothrombotic disorder (eg, antithrombin III, protein C or S deficiency)
  • Life expectancy less than study duration (110 days)
  • Platelet count of \< 20 × 109/L on the day of dose 1 (Day 1) or within 7 days before first dosing
  • Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2
  • Treatment with antiplatelet or anticoagulant medication, including thrombosis prophylaxis, within 10 days prior to insertion of the PICC
  • Chemotherapy regimen that would be expected to drop the platelet count to \< 20 × 109/L
  • Chemotherapy regimen with heparin mixed into IV bags (eg, dalteparin 2500 IU/day)
  • Difficult IV access that would prevent infusion of the IP
  • In situ central venous catheter (CVC) or PICC in the 3 months before the Screening Visit. The study PICC must be inserted in the contralateral side, which must be PICC / CVC naïve
  • Undergoing dialysis or have another inserted intravascular foreign surface device
  • Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≥ 4 × upper limit of normal
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    CSL312 Cohort 1 (Dose 1)

    CSL312 administered as IV infusion

    Drug: CSL312

  • Experimental
    CSL312 Cohort 2 (Dose 2)

    CSL312 administered as IV infusion

    Drug: CSL312

  • Experimental
    CSL312 Cohort 3 (Dose 3)

    CSL312 administered as IV infusion

    Drug: CSL312

  • Experimental
    CSL312 Cohort 4 (Dose 4)

    CSL312 administered as IV infusion

    Drug: CSL312

  • Placebo comparator
    Placebo

    Placebo administered as IV infusion

    Drug: Placebo

Interventions

  • DrugCSL312

    CSL312 administered as an IV infusion

    Also known as: Garadacimab

  • DrugPlacebo

    Solution of 70% 0.9% saline / 30% CSL312 diluent

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What researchers measure

Primary outcomes

  1. Number of subjects with PICC-associated thrombosis

    PICC-associated thrombosis which can be either: 1. Asymptomatic PICC associated thrombosis detected by Duplex ultrasound (DUS) or venography at Day 15 or Day 29 after PICC insertion or 2. Symptomatic PICC associated thrombosis up to Day 29 after PICC insertion, suspected clinically due to symptoms of the upper limb or neck, and objectively confirmed by DUS or venography

    Time frame: Up to 29 days after PICC insertion

  2. Percent of subjects with PICC-associated thrombosis

    PICC-associated thrombosis which can be either: 1. Asymptomatic PICC associated thrombosis detected by Duplex ultrasound (DUS) or venography at Day 15 or Day 29 after PICC insertion or 2. Symptomatic PICC associated thrombosis up to Day 29 after PICC insertion, suspected clinically due to symptoms of the upper limb or neck, and objectively confirmed by DUS or venography

    Time frame: Up to 29 days after PICC insertion

Secondary outcomes

  1. Overall percentage of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Time frame: Up to 110 days after first dose of CSL312

  2. Percent of subjects with related TEAEs

    Time frame: Up to 110 days after first dose of CSL312

  3. Percent of subjects with TEAEs by severity

    Time frame: Up to 110 days after first dose of CSL312

  4. Number of subjects treated with CSL312 with detectable antibodies to CSL312

    Time frame: Up to 110 days after first dose of CSL312

  5. Percent of subjects treated with CSL312 with detectable antibodies to CSL312

    Time frame: Up to 110 days after first dose of CSL312

  6. Maximum plasma concentration (Cmax) of CSL312

    Time frame: Up to 110 days after first dose of CSL312

  7. Area under the concentration-time curve (AUC0-t) of CSL312

    Time frame: Up to 110 days after first dose of CSL312

  8. Time of maximum plasma concentration (Tmax) of CSL312

    Time frame: Up to 110 days after first dose of CSL312

  9. Terminal elimination half-life (T1/2) of CSL312

    Time frame: Up to 110 days after first dose of CSL312

  10. Total systemic clearance (CLtot) of CSL312

    Time frame: Up to 110 days after first dose of CSL312

  11. Volume of distribution during the elimination phase (Vz) of CSL312

    Time frame: Up to 110 days after first dose of CSL312

  12. Accumulation Ratio (AR) of CSL312

    Time frame: Up to 110 days after first dose of CSL312

  13. Number of subjects with thrombosis-associated catheter occlusion

    Time frame: Up to 29 days after first dose of CSL312

  14. Percent of subjects with thrombosis-associated catheter occlusion

    Time frame: Up to 29 days after first dose of CSL312

  15. Number of subjects with PICC removal or replacement

    Time frame: Up to 29 days after first dose of CSL312

  16. Percent of subjects with PICC removal or replacement

    Time frame: Up to 29 days after first dose of CSL312

  17. Number of subjects with central line-associated blood stream infections (CLABSI)

    Time frame: Up to 29 days after first dose of CSL312

  18. Percent of subjects with CLABSI

    Time frame: Up to 29 days after first dose of CSL312

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04281524
Lead sponsor
CSL Behring
Responsible party
Sponsor
First posted
Feb 24, 2020
Start date
Mar 2020 (estimated)
Primary completion
Aug 2021 (estimated)
Completion
Oct 2021 (estimated)
Last update
Mar 25, 2020

Study contacts

Study Director
study director · CSL Behring

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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