Trial · NCT07903311
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 | Estimated absolute change in whole blood hemoglobin - ID Cohort | Baseline, and approximately 3 months | Whole blood hemoglobin in g/dL at 3 months after the start of IV versus PO treatment. Full longitudinal study data from all study visits will be modeled in a linear mixed-effects model which will include time from start of treatment, the treatment (IV versus PO), and interactions between the time and treatment at approximately 1, 3, and 6 months. |
| Secondary | Estimated absolute change in whole blood hemoglobin - ID Cohort | Baseline, and approximately 1 and 6 months | Whole blood hemoglobin in g/dL at 1 and 6 months after the start of IV versus PO treatment will be modeled using approaches described in Outcome 1. |
| Secondary | Estimated proportion of non-anemic participants - ID Cohort | Baseline, and approximately 1, 3, and 6 months | Proportion of non-anemic participants over time will be modeled based on an inverse probability weighted generalized estimating equations (GEE) model for the binary variable of hemoglobin value meeting WHO criteria for anemia versus not anemia. |
| Secondary | Estimated relative change in soluble transferrin receptor (sTfR) - ID Cohort | Baseline, and approximately 1, 3, and 6 months | Serum sTfR in % of mg/L at 1, 3, and 6 months will be modeled using approaches described in Outcome 1. |
| Secondary | Estimated absolute change in transferrin saturation (TSAT) - ID Cohort | Baseline, and approximately 1, 3, and 6 months | Serum TSAT in % at 1, 3, and 6 months, determined by total serum iron and iron binding capacity, will be modeled using approaches described in Outcome 1. |
| Secondary | Estimated absolute change in serum iron - ID Cohort | Baseline, and approximately 1, 3, and 6 months | Serum iron in ug/dL at 1, 3, and 6 months will be modeled using approaches described in Outcome 1. |
| Secondary | Estimated absolute change in serum ferritin - ID Cohort | Baseline, and approximately 1, 3, and 6 months | Serum ferritin in ng/mL at 1, 3, and 6 months will be modeled using approaches described in Outcome 1. |
| Secondary | Estimated absolute change in serum ferritin(adj-factor) - ID Cohort | Baseline, and approximately 1, 3, and 6 months | Adjusted serum ferritin using the correction factor method for C-reactive protein (CRP) in ng/mL at 1, 3, and 6 months will be modeled using approaches described in Outcome 1. |
| Secondary | Estimated absolute change in serum ferritin(adj-BRINDA) - ID Cohort | Baseline, and approximately 1, 3, and 6 months | Adjusted serum ferritin using the BRINDA method for CRP in ng/mL at 1, 3, and 6 months will be modeled using approaches described in Outcome 1. |
| Secondary | Estimated absolute change in sTfR index - ID Cohort | Baseline, and approximately 1, 3, and 6 months | sTfR index calculated by sTfR / log (ferritin) at 1, 3, and 6 months will be modeled using approaches described in Outcome 1. |
| Secondary | Estimated absolute change in whole blood red blood cell (RBC) mean corpuscular volume (MCV) - ID cohort | Baseline, and approximately 1, 3, and 6 months | RBC MCV in fL at 1, 3, and 6 months will be modeled using approaches described in Outcome 1. |
| Secondary | Estimated absolute change in 6-minute walk distance (6MWD) - ID Cohort | Baseline, and approximately 1, 3, and 6 months | 6MWD in meters at 1, 3, and 6 months will be modeled using approaches described in Outcome 1. |
| Secondary | Estimated change in percent predicted forced expiratory volume in the first second (ppFEV1) - ID Cohort | Baseline, and approximately 1, 3, and 6 months | ppFEV1 measured by spirometry in % at 1, 3, and 6 months will be modeled using approaches described in Outcome 1. |
| Secondary | Estimated absolute change in hand grip strength - ID Cohort | Baseline, and approximately 1, 3, and 6 months | Hand grip strength in lbs, assessed using the Jamar dynamometer, at 1, 3, and 6 months will be modeled using approaches described in Outcome 1. |
| Secondary | Estimated absolute change in body mass index (BMI) - ID Cohort | Baseline, and approximately 1, 3, and 6 months | BMI measured by height and weight in kg/m2 at 1, 3, and 6 months will be modeled using approaches described in Outcome 1. |
| Secondary | Estimated absolute change in fatigue severity score (FSS) - ID Cohort | Baseline, and approximately 1, 3, and 6 months | FSS at 1, 3, and 6 months will be modeled using approaches described in Outcome 1. The FSS is a 9 question scale, with raw score range of 9-63, and final score range of 1-7, with higher scores indicating more fatigue. |
| Secondary | Estimated absolute change in cystic fibrosis questionnaire revised (CFQ-R) - ID Cohort | Baseline, and approximately 1, 3, and 6 months | CFQ-R scores captured using the ≥ 14 years of age questionnaire at 1, 3, and 6 months will be modeled using approaches described in Outcome 1. The CFQ-R is reported in separate domains, with a score range of 0-100 for each domain, with higher scores indication better health-related quality of life. |
| Secondary | Estimated absolute change in gastrointestinal symptom score (GI-SS) - ID Cohort | Baseline, and approximately 1, 3, and 6 months | Total number of present GI symptoms, out of 8 total assessed in Section C of the questionnaire, at 1, 3, and 6 months will be modeled using approaches described in Outcome 1. Additionally, numerical severity of symptoms will be modeled (0=absent, 1=mild, 2=moderate, 3=severe) using the same approach. A higher number indicates more severe GI symptoms. |
| Secondary | Time to next distal intestinal obstruction syndrome (DIOS) event - ID Cohort | Start of treatment through the approximate 6-month study period | All unique DIOS events which occur from start of IV versus PO treatment through the duration of follow-up will be modeled using the Xia/Murray/Tayob method, which is a robust multivariable restricted time model with the capacity to analyze repeated time-to-event data throughout the study period. |
| Secondary | Time to next pulmonary exacerbation (PEx) - ID Cohort | Start of treatment through the approximate 6-month study period | All unique PEx events which occur from start of IV versus PO treatment through the duration of follow-up will be modeled using the Xia/Murray/Tayob method, which is a robust multivariable restricted time model with the capacity to analyze repeated time-to-event data throughout the study period. |
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.
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