Trial Outcomes & Findings for Viral Specific T-Lymphocytes to Treat Adenovirus, CMV and EBV (NCT NCT04364178)
NCT ID: NCT04364178
Last Updated: 2026-05-27
Results Overview
Cumulative number of patients who develop Grade III-IV acute graft versus host disease (GVHD) attributed to the viral specific T cells.
TERMINATED
PHASE1/PHASE2
8 participants
Day 0 through 90 days after last cellular infusion (last infusion occurred up to 38 days post day 0)
2026-05-27
Participant Flow
Participants were enrolled at UPMC (University of Pittsburgh Medical Center). Participants were able to receive up to 5 infusions. If a subject showed a partial response, defined as a decrease in viral load of at least 50% from baseline or 50% improvement of clinical signs and symptoms, or no response, they were eligible to receive up to 4 additional cellular infusions from the same donor, at a minimum of 14-day intervals.
Participant milestones
| Measure |
Viral Specific T-Lymphocytes
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system.
Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
Received Treatment
|
5
|
|
Overall Study
Received Only 1 Infusion
|
4
|
|
Overall Study
Received 2 Infusions
|
1
|
|
Overall Study
Number of Subjects That Received CMV VSTs
|
2
|
|
Overall Study
Number of Subjects That Received Adenovirus VSTs
|
3
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Viral Specific T-Lymphocytes
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system.
Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
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|---|---|
|
Overall Study
Screen Failed
|
3
|
Baseline Characteristics
Viral Specific T-Lymphocytes to Treat Adenovirus, CMV and EBV
Baseline characteristics by cohort
| Measure |
Viral Specific T-Lymphocytes
n=8 Participants
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system.
Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
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|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=51 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=51 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=51 Participants
|
|
Age, Continuous
|
8 years
n=51 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: Day 0 through 90 days after last cellular infusion (last infusion occurred up to 38 days post day 0)Population: 3 of the total enrolled participants did not receive treatment after screening
Cumulative number of patients who develop Grade III-IV acute graft versus host disease (GVHD) attributed to the viral specific T cells.
Outcome measures
| Measure |
Viral Specific T-Lymphocytes
n=5 Participants
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system.
Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
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|---|---|
|
Number of Patients With Grade III-IV Acute Graft Versus Host Disease
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 0 through 90 days after last cellular infusion (last infusion occurred up to 38 days post day 0)Population: 3 of the total enrolled participants did not receive treatment after screening
Cumulative number of patients with CTCAE Grade 4/5 Adverse events which occurred after infusion
Outcome measures
| Measure |
Viral Specific T-Lymphocytes
n=5 Participants
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system.
Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
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|---|---|
|
Number of Patients Who Experienced Grade 4/5 Adverse Events After Infusion
|
0 Participants
|
SECONDARY outcome
Timeframe: First cellular infusion to 6 months post first cellular infusion (last infusion occurred up to 38 days post day 0)Population: 3 of the total enrolled participants did not receive treatment after screening
Cumulative number of patients surviving at 6 months
Outcome measures
| Measure |
Viral Specific T-Lymphocytes
n=5 Participants
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system.
Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
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|---|---|
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Number of Patients Who Reached 6 Month Survival
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 year after first infusionPopulation: 3 of the total enrolled participants did not receive treatment after screening
Cumulative number of patients who were treated and surviving one year later
Outcome measures
| Measure |
Viral Specific T-Lymphocytes
n=5 Participants
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system.
Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
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|---|---|
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Number of Patients Who Achieved One Year Survival
|
4 Participants
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SECONDARY outcome
Timeframe: 1, 3, and 6 months after first infusionPopulation: 3 of the total enrolled participants did not receive treatment after screening
Complete response to the virus is defined as a resolution of viremia or below limit of quantification OR complete resolution of all related clinical signs and symptoms for CMV, non lymphoproliferative EBV, and adenovirus. For lymphoproliferative EBV, complete response is defined as the resolution of related radiographic disease.
Outcome measures
| Measure |
Viral Specific T-Lymphocytes
n=5 Participants
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system.
Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
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|---|---|
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Patients Who Achieved Viral Response (Complete Response) to Treatment
1 month after first infusion
|
3 Participants
|
|
Patients Who Achieved Viral Response (Complete Response) to Treatment
3 months after first infusion
|
4 Participants
|
|
Patients Who Achieved Viral Response (Complete Response) to Treatment
6 months after first infusion
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline through 6 months after last infusionPopulation: 3 of the total enrolled participants did not receive treatment after screening
Complete response to the virus is defined as a resolution of viremia or below limit of quantification OR complete resolution of all related clinical signs and symptoms for CMV, non lymphoproliferative EBV, and adenovirus. For lymphoproliferative EBV, complete response is defined as the resolution of related radiographic disease.
Outcome measures
| Measure |
Viral Specific T-Lymphocytes
n=4 Participants
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system.
Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
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|---|---|
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Number of Days to Patient Complete Response to Viral Specific Infusion
|
22.5 days
Interval 8.0 to 89.0
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SECONDARY outcome
Timeframe: Day 0 through 6 months after last infusionPopulation: 3 of the total enrolled participants did not receive treatment after screening; One of the patients treated did not achieve a compete response and did not wean off antiviral treatment
The number of days after the VST infusion that the antiviral agent used for treatment of the specific virus was stopped.
Outcome measures
| Measure |
Viral Specific T-Lymphocytes
n=4 Participants
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system.
Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
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|---|---|
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Number of Days Post-VST Infusion Upon Which Viral Specific Antimicrobial Treatment Was Discontinued.
|
23 days
Interval 8.0 to 36.0
|
SECONDARY outcome
Timeframe: Baseline through 6 months after last infusionPopulation: 3 of the total enrolled participants did not receive treatment after screening
Immune reconstitution is defined as CD4 lymphocyte count greater than 50/microliter
Outcome measures
| Measure |
Viral Specific T-Lymphocytes
n=5 Participants
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system.
Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
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|---|---|
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Number of Days Post VST Infusion That Patients Achieved T Cell Immune Reconstitution
|
81 days
Interval 28.0 to 109.0
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Adverse Events
Viral Specific T-Lymphocytes
Serious adverse events
| Measure |
Viral Specific T-Lymphocytes
n=5 participants at risk
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system.
Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
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|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
Disseminated CMV
|
20.0%
1/5 • Up to 1 year
|
Other adverse events
| Measure |
Viral Specific T-Lymphocytes
n=5 participants at risk
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system.
Adenovirus Specific T- Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
Cytomegalovirus Specific T-Lymphocytes: Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
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|---|---|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
1/5 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
1/5 • Up to 1 year
|
|
Investigations
Lymphocyte count decreased
|
40.0%
2/5 • Up to 1 year
|
|
Renal and urinary disorders
Meatal stenosis with ballooning
|
20.0%
1/5 • Up to 1 year
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Up to 1 year
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
Viremia
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
Urinary Tract Infection
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
Adenovirus - blood
|
40.0%
2/5 • Up to 1 year
|
|
Infections and infestations
Adenovirus - stool
|
20.0%
1/5 • Up to 1 year
|
|
Investigations
Alanine Aminotransferase increased
|
20.0%
1/5 • Up to 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Up to 1 year
|
|
Infections and infestations
Aspartate aminotransferase increased
|
20.0%
1/5 • Up to 1 year
|
|
Investigations
CD4 lymphocytes decreased
|
20.0%
1/5 • Up to 1 year
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
20.0%
1/5 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Up to 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Up to 1 year
|
|
Investigations
Gamma glutamyl transferase increased
|
20.0%
1/5 • Up to 1 year
|
|
Gastrointestinal disorders
Gastroparesis
|
20.0%
1/5 • Up to 1 year
|
|
Vascular disorders
Hypertension
|
40.0%
2/5 • Up to 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place