Trial · NCT04154826
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determination of the proportion of subjects with Acid Fast Bacilli (AFB) sputum culture conversion to negative at day 180. | six months | Percentage of participants with 3 consecutive monthly, negative Acid Fast Bacilli sputum cultures at any time within first 6 months |
| Secondary | Efficacy by kinetic of AFB sputum culture conversion to negative. | one year | number of patients with negative sputum conversion measured at days 28, 56, 84, 112, 140, 180, 240, 300, and 360. |
| Secondary | Improvement of functional capacity response assessed by the median change in the 6-minute walk distance compared to baseline. | one year | Increase in 6-minute walking distance measured at days 84, 180 and 360 over baseline distance |
| Secondary | Improvement of functional capacity response assessed by the median change in oxygen saturation compared to baseline. | one year | Increase in oxygen saturation measured at days 84, 180 and 360 over baseline value |
| Secondary | Pulmonary function response measured by the median improvement in the Forced expiratory volume during the first second (FEV1). | one year | ratio of Forced Expiratory Volume during the first second (FEV1) measured at days 180 and 360 over the same measure at baseline. |
| Secondary | Radiological response on chest CT compared to baseline | one year | Surface area of lung involved by clinical chest computerized tomography (CT) scans at days 180 and 360 compared to baseline |
| Secondary | Improvement of Health-related Quality of Life (HRQoL) | one year | Patient-Reported Outcomes Measurement Information System (PROMIS-29 ) measured at days 56, 84, 180, 300 and 360 and compared to baseline. (The mean healthy population score is 50. The score increases with worsening medical condition.) |
| Secondary | Number of hospital readmissions | one year | Cumulated Number of hospital (Intensive care unit or emergency room ) visits at days 56, 84, 180, 300 and 360 |
| Secondary | C max (maximal plasma concentration) pharmacokinetic of CYT107 in this population | One day | At Day 1 and Day 78 measure of CYT107 Cmax |
| Secondary | Plasma concentration area under curve (AUC) pharmacokinetic of CYT107 in this population | One day | At Day 1 and Day 78 measure of CYT107 AUC |
| Secondary | Clinical tolerance of CYT107 indicated by the study drop-out rate (%) regardless of the cause. | six months | Percentage of patients who dropout of the study at days 28, 84, 180 |
| Secondary | Proportion of patients developing any grade 3-4 adverse events or deaths | one year | Percentage of patients with grade 3-4 adverse events (assessed by CTCAE version 5.0) or deaths through day 360. |
| Secondary | Measure of CYT107 immunogenicity | 1 year | Number of patients with presence of binding and neutralizing antibodies at day 15, 29, 57, 90 and 120 compared to baseline. Testing for immunogenicity will be repeated at day 180 and again at day 360 only if positive antibodies are detected at previous sampling timepoint. |
| Other | IL-7 effect on opportunistic bacterial, viral or fungal infections | one year | The incidence of new bacterial, fungal, or viral infections requiring medical treatment will be quantitated and captured during the interim history at each visit through Day 360. |
| Other | IL-7 Effects on immune cells counts | one year | The absolute lymphocyte, monocyte, and neutrophil counts will be assessed and compared to baseline values at days 28, 56, 84, 180 and one year (about day 360) |
| Other | IL-7 Effects on CD4+ and CD8+ T lymphocytes | one year | The absolute CD4+ and CD8+ T cell counts will be assessed and compared to baseline values at days 28, 56, 84, 180 and one year (about day 360) |
| Other | IL-7 Effects on immune T cell markers | 2 months | Peripheral blood cellular immune biomarkers including CD4 and CD8 T cell expression of soluble IL-7 receptor α (CD127), PD-1, and Ki67 and monocyte HLA-DR expression will be assessed at baseline and days 28, 56 |
| Other | IL-7 Effects on circulating cytokines | 2 months | Circulating cytokines including Tumor necrosis factor (TNF-α), IL-6, and IL-10 will be measured by ELISA at baseline, Day 1 and day 56 |
| Other | IL-7 Effects on cellular cytokine production | 3 months | ELISpot assays for stimulated production of Interferon (IFN-γ) and TNF-α will be performed at baseline and days 28, 56 and 84 |
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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