Trial · NCT03960541
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Baseline and Week 6 | LDL-C was measured in participant serum. The percent change from baseline at Week 6 is presented. |
| Primary | Number of Participants With ≥1 Adverse Event (AE) | Up to approximately 28 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Any worsening of a preexisting condition which is temporally associated with the use of the study treatment is also considered an AE. The number of participants who experienced an AE is presented. |
| Primary | Number of Participants Who Withdrew From Study Treatment Due to an AE | Up to approximately 4 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Any worsening of a preexisting condition which is temporally associated with the use of the study treatment is also considered an AE. The number of participants who withdrew from study treatment due to an AE is presented. |
| Secondary | Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein-Cholesterol (HDL-C), and Triglycerides | Baseline, Week 6, and Week 28 | Total cholesterol, HDL-C, and triglycerides were measured in participant serum. The percent change from baseline at Weeks 6 and 28 for these lipid panel results is presented. |
| Secondary | Percent Change From Baseline in Cluster of Differentiation 4 (CD4)+ and Cluster of Differentiation 8 (CD8)+ T Cell Percentage | Baseline, Week 6, and Week 28 | The percent change from baseline in the percentage of T Cells in whole blood that are CD4+ and CD8+ at Weeks 6 and 28 was to be presented. |
| Secondary | Percent Change From Baseline in Interferon (IFN)+ Peripheral Blood Mononuclear Cells (PBMCs) | Baseline, Week 6, and Week 28 | The percent change from baseline in the percentage of PBMCs that were INF+ at Weeks 6 and 28 was to be presented. |
| Secondary | Percent Change From Baseline in Tumor Necrosis Factor (TNF)+ Peripheral Blood Mononuclear Cells (PBMCs) | Baseline, Week 6, and Week 28 | The percent change from baseline in the percentage of PBMCs that were TNF+ at Weeks 6 and 28 was to be presented. |
| Secondary | Percent Change From Baseline in Whole Blood Soluble Cluster of Differentiation 14 (sCD14) Concentration | Baseline, Week 6, and Week 28 | The percent change from baseline in sCD14 concentration in whole blood at Weeks 6 and 28 was to be presented. |
| Secondary | Change From Baseline in Human Immunodeficiency Virus (HIV) Proviral Deoxyribonucleic Acid (DNA) | Baseline, Week 6, and Week 28 | Blood was collected at baseline, Week 6, and Week 28 for the determination of the number of copies of HIV proviral DNA in PBMCs. The change from baseline at Weeks 6 and 28 was to be presented. |
| Secondary | Percent Change From Baseline in Troponin I and Troponin T Serum Levels | Baseline and Week 28 | Troponin I and troponin T blood concentrations were to be measured. The percent change from baseline at Week 28 was to be presented. |
| Secondary | Percent Change From Baseline in Controlled Attenuation Parameter (CAP) as Determined by Transient Elastography of the Liver | Baseline and Week 28 | CAP is a measure related to hepatic steatosis. CAP was measured in decibels per meter (dB/m) at baseline and Week 28. The percent change is presented. |
| Secondary | Percent Change From Baseline in Liver Stiffness as Determined by Transient Elastography of the Liver | Baseline and Week 28 | Liver stiffness is a measure related to hepatic fibrosis. Liver stiffness was measured in kilopascals (kPa) at baseline and Week 28. The percent change is presented. |
| Secondary | Percent Change From Baseline in Leptin | Baseline, Week 6, and Week 28 | Leptin concentration was measured in participant serum. The percent change from baseline at Weeks 6 and 28 is presented. |
| Secondary | Percent Change From Baseline in Glycated Hemoglobin (HbA1c) | Baseline, Week 6, and Week 28 | Glycated hemoglobin (HbA1c) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage HbA1c is the ratio of glycated hemoglobin to total hemoglobin x 100. The percent change from baseline at Weeks 6 and 28 is presented. |
| Secondary | Area Under the Plasma Concentration Versus Time Curve (AUC) of CD24Fc | Predose and 2 hours postdose at the Week 0, 2, and 4 visits; Any time during the Week 6, 16, and 28 visits. | AUC was defined as the area of plasma concentration versus time curve from time zero to Week 28. Assessment of AUC was to be based on CD24Fc concentration measured in plasma samples collected at each study visit starting with Week 0. |
| Secondary | Number of Participants With New Anti-Drug Antibodies | Baseline, Week 6, and Week 28 | Anti-CD24Fc antibodies were to be quantified in participant blood samples. The number of participants who demonstrated development of new anti-drug antibodies were to be presented. |
| Secondary | Change From Baseline in Interluekin-6 (IL-6) Levels Following CD24Fc Treatment | Baseline and Week 28 | Levels of IL-6 were to be measured in participant blood samples collected at baseline and Week 28. The change from baseline in IL-6 levels were to be presented. |
| Secondary | Change From Baseline in Apolipoprotein B (apoB) Levels | Baseline and Week 28 | Levels of apoB were measured in participant blood samples collected at baseline and Week 28. The change from baseline level is presented. |
| Secondary | Change From Baseline in Lipoprotein(a) (Lp[a]) Levels | Baseline and Week 28 | Levels of Lp(a) were measured in participant blood samples collected at baseline and Week 28. The change from baseline level is presented. |
| Secondary | Change From Baseline in Urine Albumin:Creatinine Ratio | Baseline and Week 28 | The ratio between levels of albumin and creatine was measured in participant urine at baseline and Week 28. The change from baseline in the ratio is presented. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
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