Trials / Withdrawn
WithdrawnNCT04281524
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 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
- Status
- Withdrawn
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CSL312 | CSL312 administered as an IV infusion |
| DRUG | Placebo | Solution of 70% 0.9% saline / 30% CSL312 diluent |
Timeline
- Start date
- 2020-03-01
- Primary completion
- 2021-08-01
- Completion
- 2021-10-01
- First posted
- 2020-02-24
- Last updated
- 2020-03-25
Source: ClinicalTrials.gov record NCT04281524. Inclusion in this directory is not an endorsement.