Trial · NCT03899480
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Events | throughout trial participation: 100 days post infusion | Toxicity and adverse events will be classified according to Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events v2.0. Scale ranges from grade 0 to 4 with a grade of 0 indicating normal signs and symptoms and a grade of 4 indicating potentially life-threatening signs and symptoms. Grade 2, 3, and 4 adverse events will be considered when determining the safety and tolerability of treatment. |
| Primary | CBC; White Blood Cell Count | 2, 3, 10, and 21 days post infusion | Comprehensive metabolic panel will be performed at days 2, 3, 10, 21 post infusion to aid in the continuous assessment of safety and tolerability throughout the study. White blood cell count will be evaluated by principle investigator. WBC outside of established clinical reference range (4.5-11.0 k/ul) may indicate adverse treatment reaction. Total occurrence of abnormal CBC results will be used to determine treatment safety and tolerability. |
| Primary | CBC; Red Blood Cell Count | 2, 3, 10, and 21 day post infusion | Complete blood count will be performed at days 2, 3, 10, 21 post infusion to aid in the continuous assessment of safety and tolerability throughout the study. Red blood cell count will be evaluated by principle investigator. RBC outside established clinical reference range (2.5-5.5 mil/ul) may indicate adverse treatment reaction. Total occurrence of abnormal CBC results will be used to determine treatment safety and tolerability. |
| Primary | CBC; Hemoglobin | 2, 3, 10, and 21 days post infusion | Complete blood count will be performed at days 2, 3, 10, 21 post infusion to aid in the continuous assessment of safety and tolerability throughout the study. Hemoglobin will be evaluated by principle investigator. Hemoglobin outside established clinical reference range (14-17 g/dl) may indicate adverse treatment reaction. Total occurrence of abnormal hemoglobin results will be used to determine treatment safety and tolerability. |
| Primary | CBC; Hematocrit | 2, 3, 10, and 21 days post infusion | Complete blood count will be performed at days 2, 3, 10, 21 post infusion. Hematocrit will be evaluated by principle investigator. Hematocrit outside established clinical reference range (42-52%) may indicate adverse treatment reaction. Total occurrence of abnormal hematocrit results will be used to determine treatment safety and tolerability. |
| Primary | CBC; Mean Corpuscular Volume | 2, 3, 10, and 21 days post infusion | Complete blood count will be performed at days 2, 3, 10, 21 post infusion to aid in the continuous assessment of safety and tolerability throughout the study. MCV will be evaluated by principle investigator. MCV outside established clinical reference range (84-96 fl.) may indicate adverse treatment reaction. Total occurrence of abnormal MCV results will be used to determine treatment safety and tolerability. |
| Primary | CBC; Mean Corpuscular Hemoglobin | 2, 3, 10, and 21 days post infusion | Complete blood count will be performed at days 2, 3, 10, 21 post infusion to aid in the continuous assessment of safety and tolerability throughout the study. MCH will be evaluated by principle investigator. MCH outside established clinical reference range (28-34 pg) may indicate adverse treatment reaction. Total occurrence of abnormal MCH results will be used to determine treatment safety and tolerability. |
| Primary | CBC; Mean Corpuscular Hemoglobin Concentration | 2, 3, 10, and 21 days post infusion | Complete blood count will be performed at days 2, 3, 10, 21 post infusion to aid in the continuous assessment of safety and tolerability throughout the study. MCHC will be evaluated by principle investigator. MCHC outside established clinical reference range (33-36 g/dl) may indicate adverse treatment reaction. Total occurrence of abnormal MCHC results will be used to determine treatment safety and tolerability. |
| Primary | CMP; Sodium | 2, 3, 10, and 21 days post infusion | Comprehensive metabolic panel will be performed at days 2, 3, 10, 21 post infusion to aid in the continuous assessment of safety and tolerability throughout the study. Sodium concentration will be evaluated by principle investigator. Sodium concentration outside established clinical reference range (136-145 mmol/l) may indicate adverse treatment reaction. Total occurrence of abnormal sodium concentration results will be used to determine treatment safety and tolerability. |
| Primary | CMP; Potassium | 2, 3, 10, and 21 days post infusion | Comprehensive metabolic panel will be performed at days 2, 3, 10, 21 post infusion to aid in the continuous assessment of safety and tolerability throughout the study. Potassium concentration will be evaluated by principle investigator. Potassium concentration outside established clinical reference range (3.5-5.1 mmol/l) may indicate adverse treatment reaction. Total occurrence of abnormal potassium concentration results will be used to determine treatment safety and tolerability. |
| Primary | CMP; Chloride | 2, 3, 10, and 21 days post infusion | Comprehensive metabolic panel will be performed at days 2, 3, 10, 21 post infusion to aid in the continuous assessment of safety and tolerability throughout the study. Chloride concentration will be evaluated by principle investigator. Chloride concentration outside established clinical reference range (98-107 mmol/l) may indicate adverse treatment reaction. Total occurrence of abnormal chloride concentration results will be used to determine treatment safety and tolerability. |
| Primary | CMP; Glucose | 2, 3, 10, and 21 days post infusion | Comprehensive metabolic panel will be performed at days 2, 3, 10, 21 post infusion to aid in the continuous assessment of safety and tolerability throughout the study. Glucose concentration will be evaluated by principle investigator. Glucose concentration outside established clinical reference range (70-99 mg/dl) may indicate adverse treatment reaction. Total occurrence of abnormal glucose concentration results will be used to determine treatment safety and tolerability. |
| Primary | CMP; Calcium | 2, 3, 10, and 21 days post infusion | Comprehensive metabolic panel will be performed at days 2, 3, 10, 21 post infusion to aid in the continuous assessment of safety and tolerability throughout the study. Calcium concentration will be evaluated by principle investigator. Calcium concentration outside established clinical reference range (8.2-10.2 mg/dl) may indicate adverse treatment reaction. Total occurrence of abnormal calcium concentration results will be used to determine treatment safety and tolerability. |
| Primary | CMP; Blood Urea Nitrogen | 2, 3, 10, and 21 days post infusion | Comprehensive metabolic panel will be performed at days 2, 3, 10, 21 post infusion to aid in the continuous assessment of safety and tolerability throughout the study. BUN concentration will be evaluated by principle investigator. BUN concentration outside established clinical reference range (6-25 mg/dl) may indicate adverse treatment reaction. Total occurrence of abnormal BUN concentration results will be used to determine treatment safety and tolerability. |
| Primary | CMP; Creatinine | 2, 3, 10, and 21 days post infusion | Comprehensive metabolic panel will be performed at days 2, 3, 10, 21 post infusion to aid in the continuous assessment of safety and tolerability throughout the study. Creatinine concentration will be evaluated by principle investigator. Creatinine concentration outside established clinical reference range (0.8-1.3 mg/dl) may indicate adverse treatment reaction. Total occurrence of abnormal creatinine concentration results will be used to determine treatment safety and tolerability. |
| Primary | CMP; Alkaline Phosphatase | 2, 3, 10, and 21 days post infusion | Comprehensive metabolic panel will be performed at days 2, 3, 10, 21 post infusion to aid in the continuous assessment of safety and tolerability throughout the study. Alkaline phosphatase concentration will be evaluated by principle investigator. Alkaline phosphatase concentration outside established clinical reference range (26-137 u/l) may indicate adverse treatment reaction. Total occurrence of abnormal alkaline phosphatase concentration results will be used to determine treatment safety and tolerability. |
| Primary | CMP; Alanine Transaminase | 2, 3, 10, and 21 days post infusion | Comprehensive metabolic panel will be performed at days 2, 3, 10, 21 post infusion to aid in the continuous assessment of safety and tolerability throughout the study. Alanine transaminase concentration will be evaluated by principle investigator. Alanine transaminase concentration outside established clinical reference range (15-65 u/l) may indicate adverse treatment reaction. Total occurrence of abnormal alanine transaminase concentration results will be used to determine treatment safety and tolerability. |
| Primary | CMP; Aspartate Transaminase | 2, 3, 10, and 21 days post infusion | Comprehensive metabolic panel will be performed at days 2, 3, 10, 21 post infusion to aid in the continuous assessment of safety and tolerability throughout the study. Aspartate transaminase concentration will be evaluated by principle investigator. Aspartate transaminase concentration outside established clinical reference range (0-37 u/l) may indicate adverse treatment reaction. Total occurrence of abnormal aspartate transaminase concentration results will be used to determine treatment safety and tolerability. |
| Primary | CMP; Total Bilirubin | 2, 3, 10, and 21 days post infusion | Comprehensive metabolic panel will be performed at days 2, 3, 10, 21 post infusion to aid in the continuous assessment of safety and tolerability throughout the study. Total bilirubin concentration will be evaluated by principle investigator. Total bilirubin concentration outside established clinical reference range (\<1.1 mg/dl) may indicate adverse treatment reaction. Total occurrence of abnormal total bilirubin concentration results will be used to determine treatment safety and tolerability. |
| Primary | CMP; Albumin | 2, 3, 10, and 21 days post infusion | Comprehensive metabolic panel will be performed at days 2, 3, 10, 21 post infusion to aid in the continuous assessment of safety and tolerability throughout the study. Serum albumin will be evaluated by principle investigator. Serum albumin concentration outside established clinical reference range (3.2-4.7 g/dl) may indicate adverse treatment reaction. Total occurrence of abnormal serum albumin concentration results will be used to determine treatment safety and tolerability. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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