ThrombosisPhase 2NCT07498517
Safety and Efficacy of a Single Dose of Gruticibart to Prevent CRT
A Phase 2 study testing Gruticibart, Ultrasound and Biopspecimen collection in people with Thrombosis, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This phase II trial studies how well gruticibart works in reducing the incidence of catheter-related thrombosis (CRT) blood clots in patients with a central venous catheter (CVC) inserted. Many patients develop blood clots from their catheters and can have pain, swelling, and other symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis
- What is being tested?
- Gruticibart, Ultrasound and Biopspecimen collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2026to 2 Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Ability to understand and the willingness to sign a written informed consent document.
- Men and women, aged ≥ 18 years.
- In consultation with PI and treating physician, participant's therapy allows for a 1 to 2-day period between administration of study drug and subsequent start of planned therapy.
- Individuals that will undergo insertion of a CVC as part of planned therapy per institutional standards.
- Must have ECOG performance status ≤ 2 (refer to Appendix A).
- At time of enrollment, must have:
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- Platelet count > 50 x 109/L
- Female participants of childbearing potential must have a negative urine or serum pregnancy test during screening and at check-in Day -1. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Participants of childbearing potential are defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal.
- Female participants of childbearing potential must agree to use two forms of highly effective contraception (Appendix B) starting with the first dose of study therapy through 90 days after the last dose of study therapy.
- Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >1 year without an alternative medical cause.
- Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy.
Who cannot join
- Concurrent enrollment in another therapeutic clinical trial
- Active leukemia (lymphoma and myeloma may be included)
- Primary brain tumors or known brain metastases
- Active infection and/or current use of an oral antibiotic
- At time of enrollment:
- Deranged baseline clotting, where INR > 1.5
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- Known bleeding diathesis
- Use of anticoagulation, either therapeutic or prophylactic, for any indication at enrollment
- -At the discretion of the investigator, any other contraindication to anticoagulation therapy
- Previously documented hypersensitivity to either the drug or excipients.
- Psychiatric illness/social situations, or any other condition, that in the opinion of the investigator, would limit compliance with study requirements.
- Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 90 days after study drug administration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Joseph Shatzel, M.D., 503-494-6594, shatzel@ohsu.edu
Joseph Shatzel, M.D.
About this study
Official title: A Study to Evaluate the Safety and Efficacy of a Single Dose of Gruticibart for the Prevention of Early Catheter-related Thrombosis
This phase II trial studies how well gruticibart works in reducing the incidence of catheter-related thrombosis (CRT) blood clots in patients with a central venous catheter (CVC) inserted. Many patients develop blood clots from their catheters and can have pain, swelling, and other symptoms. They also often require blood thinners, which can increase the risk of bleeding. Gruticibart, a type of drug called a monoclonal antibody, may prevent blood clots caused by a catheter.
Read the detailed description
PRIMARY OBJECTIVE(S):
- To determine the safety of gruticibart as measured by the incidence of CRT in individuals with a CVC II. To determine the efficacy of gruticibart as measured by the incidence of CRT in individuals with a CVC II. To determine the efficacy of gruticibart as measured by the incidence of CRT in individuals with a CVC
SECONDARY OBJECTIVES:
- To evaluate the safety and tolerability of gruticibart in patients with a CVC II. To determine the efficacy of gruticibart as measured by the time to CRT and incidence of any thrombosis in individuals with a CVC
OUTLINE: Participants are randomized to 1 of 2 arms.
Arm A. Participants receive single dose of placebo IV via CVC or peripheral IV line.
Arm B. Participantsreceive single dose of gruticibart (2 mg/kg) IV via CVC or peripheral IV line.
After completion of study treatment, participants will be followed for AEs for a total of 30 days from time of administration of study drug, and are considered off-study after 30 days. .
- Conditions
- Thrombosis
- Being tested
- Placebo, Gruticibart, Ultrasound, Biopspecimen collection
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Given IV or via catheter
GruticibartDrug
2mg/kg, Given IV or via catheter
UltrasoundProcedure or surgery
Undergo ultrasound of CVC and both legs for Deep Vein Thrombosis (DVTs )
Biopspecimen collectionProcedure or surgery
Undergo blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Placebo | Placebo comparator | Placebo Receives: Drug: Placebo; Procedure: Ultrasound; Procedure: Biopspecimen collection |
| Arm B: Gruticibart | Experimental | Gruiticibart Receives: Drug: Gruticibart; Procedure: Ultrasound; Procedure: Biopspecimen collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with catheter-related thrombosis
Defined by the total incidence of symptomatic and asymptomatic thrombosis.
Measured: Day 1 to end of follow up (up to 14 days)
Incidence of major and clinically-relevant bleeding
Safety outcome is defined using the International Society of Thrombosis and Hemostasis definition of major bleeding for clinical investigations of anti-hemostatic medicinal products in nonsurgical patients
Measured: Day 1 up to end of treatment (up to 14 days)
Secondary outcomes (3)
The number of subjects with treatment-related adverse events (TEAEs)
TEAEs will be summarized using frequency counts (safety and tolerability)
Measured: Day 1 to end of folllow up (up to 30 days)
Time to detection of CRT
Mean number of minutes until CRT is detected
Measured: Day 1 to end of treatment (up to 14 days)
The number of participants with any thrombosis
Any thrombosis, including deep vein thrombosis, CRT, myocardial infarction, stroke, pulmonary embolism. Administration of gruticibart immediately preceding CVC line placement
Measured: Day 1 to end of treatment (up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start6 Aug 2026
- Primary completion2 Feb 2029 (estimated)
- Study completion2 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Oregon Health and Science University
- Responsible party
- Principal investigator, Joseph Shatzel M.D., OHSU Knight Cancer Institute
- Investigators
- Joseph Shatzel, M.D., Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498517
- Sponsor's protocol ID
- STUDY00028611
- Other IDs
- R44HL170881, 3G3-22-06
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.
PubMed 15842354
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Efficacy of a Single Dose of Gruticibart for the Prevention of Early Catheter-related Thrombosis
- ClinicalTrials.gov ID
- NCT07498517
- Acronym / sponsor ID
- STUDY00028611
- Conditions
- Thrombosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Oregon Health and Science University
- Study start
- 6 Aug 2026 (actual)
- Primary completion
- 2 Feb 2029 (estimated)
- Study completion
- 2 Oct 2029 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well gruticibart works in reducing the incidence of catheter-related thrombosis (CRT) blood clots in patients with a central venous catheter (CVC) inserted. Many patients develop blood clots from their catheters and can have pain, swelling, and other symptoms. They also often require blood thinners, which can increase the risk of bleeding. Gruticibart, a type of drug called a monoclonal antibody, may prevent blood clots caused by a catheter.
Detailed description
PRIMARY OBJECTIVE(S):
- To determine the safety of gruticibart as measured by the incidence of CRT in individuals with a CVC II. To determine the efficacy of gruticibart as measured by the incidence of CRT in individuals with a CVC II. To determine the efficacy of gruticibart as measured by the incidence of CRT in individuals with a CVC
SECONDARY OBJECTIVES:
- To evaluate the safety and tolerability of gruticibart in patients with a CVC II. To determine the efficacy of gruticibart as measured by the time to CRT and incidence of any thrombosis in individuals with a CVC
OUTLINE: Participants are randomized to 1 of 2 arms.
Arm A. Participants receive single dose of placebo IV via CVC or peripheral IV line.
Arm B. Participantsreceive single dose of gruticibart (2 mg/kg) IV via CVC or peripheral IV line.
After completion of study treatment, participants will be followed for AEs for a total of 30 days from time of administration of study drug, and are considered off-study after 30 days. .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Placebo | Placebo comparator | Drug: Placebo, Procedure: Ultrasound, Procedure: Biopspecimen collectionPlacebo |
| Arm B: Gruticibart | Experimental | Drug: Gruticibart, Procedure: Ultrasound, Procedure: Biopspecimen collectionGruiticibart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Ability to understand and the willingness to sign a written informed consent document.
- Men and women, aged ≥ 18 years.
- In consultation with PI and treating physician, participant's therapy allows for a 1 to 2-day period between administration of study drug and subsequent start of planned therapy.
- Individuals that will undergo insertion of a CVC as part of planned therapy per institutional standards.
- Must have ECOG performance status ≤ 2 (refer to Appendix A).
Key exclusion criteria (12 listed)
- Concurrent enrollment in another therapeutic clinical trial
- Active leukemia (lymphoma and myeloma may be included)
- Primary brain tumors or known brain metastases
- Active infection and/or current use of an oral antibiotic
- At time of enrollment:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboGiven IV or via catheter | Drug | Arm A: Placebo |
| Gruticibart2mg/kg, Given IV or via catheter | Drug | Arm B: Gruticibart |
| UltrasoundUndergo ultrasound of CVC and both legs for Deep Vein Thrombosis (DVTs ) | Procedure or surgery | Arm A: Placebo, Arm B: Gruticibart |
| Biopspecimen collectionUndergo blood sample collection | Procedure or surgery | Arm A: Placebo, Arm B: Gruticibart |
Primary outcome
Number of participants with catheter-related thrombosis
Time frame: Day 1 to end of follow up (up to 14 days)
Defined by the total incidence of symptomatic and asymptomatic thrombosis.
Incidence of major and clinically-relevant bleeding
Time frame: Day 1 up to end of treatment (up to 14 days)
Safety outcome is defined using the International Society of Thrombosis and Hemostasis definition of major bleeding for clinical investigations of anti-hemostatic medicinal products in nonsurgical patients
3 secondary outcomes
The number of subjects with treatment-related adverse events (TEAEs)
Time frame: Day 1 to end of folllow up (up to 30 days)
Time to detection of CRT
Time frame: Day 1 to end of treatment (up to 14 days)
The number of participants with any thrombosis
Time frame: Day 1 to end of treatment (up to 14 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 15842354Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Shatzel, M.D. principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gruticibart, Ultrasound and Biopspecimen collection in people with Thrombosis, run by OHSU Knight Cancer Institute at 1 site in United States.
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 12 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with catheter-related thrombosis (time frame: Day 1 to end of follow up (up to 14 days)). 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 NCT07498517, which also lists 1 linked publication.
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 31 Aug 2026.