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PICC-associated ThrombosisPhase 1/2NCT04281524

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 study testing CSL312 in people with PICC-associated Thrombosis, run by CSL Behring.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
PICC-associated Thrombosis
What is being tested?
CSL312
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Mar 2020to Oct 2021
Phase
Phase 1/2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

About this study

Official title: A Phase 1b, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, and Pharmacokinetics of CSL312 in the Prevention of Peripherally Inserted Central Catheter (PICC)-Associated Thrombosis in Subjects With Cancer

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.

Being tested
CSL312, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CSL312Drug

    Also called Garadacimab

    CSL312 administered as an IV infusion

  • PlaceboDrug

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

Study groups in NCT04281524
Study groupRoleWhat they receive
CSL312 Cohort 1 (Dose 1)ExperimentalCSL312 administered as IV infusion
Receives: Drug: CSL312
CSL312 Cohort 2 (Dose 2)ExperimentalCSL312 administered as IV infusion
Receives: Drug: CSL312
CSL312 Cohort 3 (Dose 3)ExperimentalCSL312 administered as IV infusion
Receives: Drug: CSL312
CSL312 Cohort 4 (Dose 4)ExperimentalCSL312 administered as IV infusion
Receives: Drug: CSL312
PlaceboPlacebo comparatorPlacebo administered as IV infusion
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: Up to 29 days after PICC insertion

Secondary outcomes (18)

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

    Measured: Up to 110 days after first dose of CSL312

  2. Percent of subjects with related TEAEs

    Measured: Up to 110 days after first dose of CSL312

  3. Percent of subjects with TEAEs by severity

    Measured: Up to 110 days after first dose of CSL312

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

    Measured: Up to 110 days after first dose of CSL312

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

    Measured: Up to 110 days after first dose of CSL312

  6. Maximum plasma concentration (Cmax) of CSL312

    Measured: Up to 110 days after first dose of CSL312

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

    Measured: Up to 110 days after first dose of CSL312

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

    Measured: Up to 110 days after first dose of CSL312

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

    Measured: Up to 110 days after first dose of CSL312

  10. Total systemic clearance (CLtot) of CSL312

    Measured: Up to 110 days after first dose of CSL312

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

    Measured: Up to 110 days after first dose of CSL312

  12. Accumulation Ratio (AR) of CSL312

    Measured: Up to 110 days after first dose of CSL312

  13. Number of subjects with thrombosis-associated catheter occlusion

    Measured: Up to 29 days after first dose of CSL312

  14. Percent of subjects with thrombosis-associated catheter occlusion

    Measured: Up to 29 days after first dose of CSL312

  15. Number of subjects with PICC removal or replacement

    Measured: Up to 29 days after first dose of CSL312

  16. Percent of subjects with PICC removal or replacement

    Measured: Up to 29 days after first dose of CSL312

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

    Measured: Up to 29 days after first dose of CSL312

  18. Percent of subjects with CLABSI

    Measured: Up to 29 days after first dose of CSL312

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2020
  2. Study startMar 2020 (estimated)
  3. Primary completionAug 2021 (estimated)
  4. Study completionOct 2021 (estimated)

Why it stopped: Business decision non-safety related.

Resources

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04281524
Sponsor's protocol ID
CSL312_1002
Status last verified
Mar 2020
First submitted
21 Feb 2020
Last updated
25 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CSL312 in people with PICC-associated Thrombosis, run by CSL Behring.

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 3 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: withdrawn, as of the sponsor's last update on 25 Mar 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with PICC-associated thrombosis (time frame: Up to 29 days after PICC insertion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04281524.

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 25 Mar 2020.

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