Deep Venous ThrombosisPhase 1/2NCT02744833
Study to Assess Safety, Tolerability, and Efficacy of GMI-1271 in Patients With Calf-level Deep Venous Thrombosis (DVT)
A Phase 1/2 study testing GMI-1271 and Enoxaparin Sodium (Lovenox®) in people with Deep Venous Thrombosis, run by GlycoMimetics Incorporated at 1 site in United States.
Trial summary
This study will evaluate the safety profile of GMI-1271 and its effect on thrombus resolution in patients with distal calf vein Deep Venous Thrombosis (DVT). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Deep Venous Thrombosis
- What is being tested?
- GMI-1271 and Enoxaparin Sodium (Lovenox®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Nov 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Male or female
- Diagnosed with acute isolated calf vein Deep Venous Thrombosis (DVT)
- Willing and able to participate in all required evaluations and procedures in this study protocol
Who cannot join
- History or presence of clinically significant medical condition or disease in the opinion of the principal investigator
- Uncontrolled acute life-threatening bacterial, viral or fungal infection
- Unable to be treated with systemic anticoagulants
- Current use of immunosuppressants, antiplatelets (other than aspirin), anticoagulants, and/or anti-epileptics
- Diagnosis of acute leukemia or multiple myeloma undergoing active treatment or maintenance treatment within the past 5 years
- Current or recent cancer treatment
Show all 11Show fewer
- Major surgery within 21 days or planned surgery during the study period
- Female subjects who are pregnant or breastfeeding
- Known history of HIV, Hepatitis B or Hepatitis C
- Alcoholism or drug use
- Clinically significant cardiovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase I/II Study to Assess the Safety, Tolerability, and Efficacy of GMI-1271 in Patients With Calf-Level Deep Venous Thrombosis
This study will evaluate the safety profile of GMI-1271 and its effect on thrombus resolution in patients with distal calf vein Deep Venous Thrombosis (DVT).
- Conditions
- Deep Venous Thrombosis
- Being tested
- GMI-1271, Enoxaparin Sodium (Lovenox®)
- Keywords
- DVT
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMI-1271Drug
Enoxaparin Sodium (Lovenox®)Drug
| Study group | Role | What they receive |
|---|---|---|
| GMI-1271 | Experimental | Not described Receives: Drug: GMI-1271 |
| Enoxaparin Sodium (Lovenox®) | Active comparator | Not described Receives: Drug: Enoxaparin Sodium (Lovenox®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of GMI-1271 in patients with calf-level DVT by assessment with vital signs, standard laboratory blood tests, electrocardiogram, and adverse event evaluation.
Adverse events will be assessed via Common Terminology Criteria for Adverse Events (CTCAE 4.03).
Measured: 19 days
Secondary outcomes (4)
To evaluate the effects of GMI-1271 on thrombus resolution or stabilization as measured by Doppler ultrasound
Measured: 19 days
To evaluate the effects of GMI-1271 on the incidence of bleeding time
Measured: 19 days
To evaluate the effects of GMI-1271 on bleeding markers such as Prothrombin time (PT)
Measured: 19 days
To evaluate the effects of GMI-1271 on biomarkers of coagulation
Measured: 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: The trial was funded in part by a grant; the trial closed when the grant ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Venous ThrombosisStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlycoMimetics Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
- Investigators
- Suman Sood, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744833
- Sponsor's protocol ID
- GMI-1271-220
- Status last verified
- Jun 2019
- First submitted
- 8 Apr 2016
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase I/II Study to Assess the Safety, Tolerability, and Efficacy of GMI-1271 in Patients With Calf-Level Deep Venous Thrombosis
- ClinicalTrials.gov ID
- NCT02744833
- Acronym / sponsor ID
- GMI-1271-220
- Conditions
- Deep Venous Thrombosis
- Keywords
- DVT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was funded in part by a grant; the trial closed when the grant ended.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- GlycoMimetics IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- University of Michigan
- Study start
- Jul 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 20 Apr 2016 (estimated)
- 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 study will evaluate the safety profile of GMI-1271 and its effect on thrombus resolution in patients with distal calf vein Deep Venous Thrombosis (DVT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GMI-1271 | Experimental | Drug: GMI-1271 |
| Enoxaparin Sodium (Lovenox®) | Active comparator | Drug: Enoxaparin Sodium (Lovenox®) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75 years
- Male or female
- Diagnosed with acute isolated calf vein Deep Venous Thrombosis (DVT)
- Willing and able to participate in all required evaluations and procedures in this study protocol
Key exclusion criteria (11 listed)
- History or presence of clinically significant medical condition or disease in the opinion of the principal investigator
- Uncontrolled acute life-threatening bacterial, viral or fungal infection
- Unable to be treated with systemic anticoagulants
- Current use of immunosuppressants, antiplatelets (other than aspirin), anticoagulants, and/or anti-epileptics
- Diagnosis of acute leukemia or multiple myeloma undergoing active treatment or maintenance treatment within the past 5 years
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 |
|---|---|---|
| GMI-1271 | Drug | GMI-1271 |
| Enoxaparin Sodium (Lovenox®) | Drug | Enoxaparin Sodium (Lovenox®) |
Primary outcome
To evaluate the safety and tolerability of GMI-1271 in patients with calf-level DVT by assessment with vital signs, standard laboratory blood tests, electrocardiogram, and adverse event evaluation.
Time frame: 19 days
Adverse events will be assessed via Common Terminology Criteria for Adverse Events (CTCAE 4.03).
4 secondary outcomes
To evaluate the effects of GMI-1271 on thrombus resolution or stabilization as measured by Doppler ultrasound
Time frame: 19 days
To evaluate the effects of GMI-1271 on the incidence of bleeding time
Time frame: 19 days
To evaluate the effects of GMI-1271 on bleeding markers such as Prothrombin time (PT)
Time frame: 19 days
To evaluate the effects of GMI-1271 on biomarkers of coagulation
Time frame: 19 days
Results and safety
The study was stopped early (reason given: The trial was funded in part by a grant; the trial closed when the grant ended.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
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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. This study is not recruiting at the moment.
Suman Sood, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GMI-1271 and Enoxaparin Sodium (Lovenox®) in people with Deep Venous Thrombosis, run by GlycoMimetics Incorporated 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 14 Jun 2019. 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. 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 stopped early (reason given: The trial was funded in part by a grant; the trial closed when the grant ended.). Results are not available in the source record.
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?
To evaluate the safety and tolerability of GMI-1271 in patients with calf-level DVT by assessment with vital signs, standard laboratory blood tests, electrocardiogram, and adverse event evaluation. (time frame: 19 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2019.