Trial · NCT04770753
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Double-Blind Period: Percentage of Participants Who Achieved Hemoglobin (Hb) Response From Week 12 Through Week 24 Compared With Baseline | Double-Blind Period: Baseline up to Week 12 through Week 24 | Hb response is defined as ≥10 grams/ liter (g/L) (1.0 gram per deciliter) (g/dL) increase in average Hb concentration from Week 12 through Week 24 compared with baseline. Hb response was tested using the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors. Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed. |
| Secondary | Double-Blind Period: Change From Baseline in Average Functional Assessment of Chronic Illness Therapy (FACIT) -Fatigue Subscale Score From Week 12 Through Week 24 | Double-Blind Period: Baseline, Week 12 through Week 24 | The FACIT-Fatigue subscale includes a 13-item self-reported fatigue subscale, which assesses the severity and impact of fatigue (including the impact on daily activities and functioning).The FACIT-Fatigue subscale is scored on a 5-point Likert scale: 0 (not at all) to 4 (very much). The total FACIT-Fatigue subscale score ranges from 0 to 52, with a higher score indicating better health-related quality of life (HRQOL). Baseline is defined as the last assessment before randomization for subjects randomized and not dosed or the last assessment before start of study treatment for subjects randomized and dosed. |
| Secondary | Double-Blind Period: Change From Baseline in Average Hb Concentration From Week 12 Through Week 24 | Double-Blind Period: Baseline, Week 12 through Week 24 | Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed. |
| Secondary | Double-Blind Period: Percentage of Participants Who Achieved Hb 1.5+ Response From Week 12 Through Week 24 Compared With Baseline | Double-Blind Period: Baseline up to Week 12 through Week 24 | Hb 1.5+ response is defined as a ≥1.5 g/dL increase in average Hb concentration from Week 12 through Week 24 compared with baseline. Hb 1.5+ response will be summarized using the Mantel-Haenszel stratum weighted method adjusting for randomization stratification factors. Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed. |
| Secondary | Double-Blind Period: Change From Baseline in Indirect Bilirubin at Week 24 | Double-Blind Period: Baseline, Week 24 | Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed. |
| Secondary | Double-Blind Period: Change From Baseline in Lactate Dehydrogenase (LDH) at Week 24 | Double-Blind Period: Baseline, Week 24 | Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed. |
| Secondary | Double-Blind Period: Change From Baseline in Haptoglobin at Week 24 | Double-Blind Period: Baseline, Week 24 | Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed. |
| Secondary | Double-Blind Period: Change From Baseline in Reticulocytes at Week 24 | Double-Blind Period: Baseline, Week 24 | Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed. |
| Secondary | Double-Blind Period: Change From Baseline in Erythropoietin at Week 24 | Double-Blind Period: Baseline, Week 24 | Baseline is defined as the average of all assessments within 42 days before randomization for subjects randomized and not dosed or within 42 days before the start of study treatment for subjects randomized and dosed. |
| Secondary | Double-Blind Period: Percentage of Participants Who Achieved Patient Global Impression of Severity (PGIS)- Fatigue Response at Weeks 12, 16, 20, and 24 | Double-Blind Period: At Weeks 12, 16, 20, and 24 | PGIS-Fatigue measured participants' perception of their fatigue severity (7-day recall) on a 4-point scale ranging from '1=none' to '4=severe'. A participant was considered to have achieved the PGIS-Fatigue response at Weeks 12, 16, 20, or 24, if their baseline to postbaseline score met one of the following conditions: 'none' at baseline to 'none' postbaseline; 'mild' to 'mild' or 'none'; 'moderate' to 'mild' or 'none'; or 'severe' to 'moderate', 'mild', or 'none'. |
| Secondary | Double-Blind Period: Percentage of Participants Who Achieved the Patient Global Impression of Change (PGIC)- Fatigue Response at Weeks 12, 16, 20, and 24 | Double-Blind Period: At Weeks 12, 16, 20, and 24 | The PGIC-Fatigue assesses change over time compared with baseline on a 5-point scale ranging from 0 to 4 where 0 indicates Much better and 4 as Much worse. A participant was considered to have achieved the PGIC-Fatigue response at Weeks 12, 16, 20, or 24 if their baseline PGIS and corresponding PGIC met one of the following conditions: if the PGIS at baseline was 'none' or 'mild' and PGIC at the visit was 'no change', 'a little better', or 'much better'; or if the PGIS at baseline was 'moderate' or 'severe' and PGIC at the visit was 'a little better' or 'much better'. |
| Secondary | Double-Blind Period: Change From Baseline in the 6-minute Walk Test (6MWT) Distance at Week 24 | Double-Blind Period: Baseline, Week 24 | The 6MWT is a well-established performance outcome (PerfO) measure that is widely used to evaluate physical activity in terms of distance walked in patients with a variety of conditions. The test measures the distance an individual can walk on a hard, flat surface in 6 minutes. |
| Secondary | Double-Blind Period: Change From Baseline in Serum Ferritin at Week 24 | Double-Blind Period: Baseline, Week 24 | Iron metabolism was assessed based on serum ferritin levels. |
| Secondary | Double-Blind Period: Change From Baseline in Transferrin Saturation (TSAT) at Week 24 | Double-Blind Period: Baseline, Week 24 | Iron metabolism was assessed based on TSAT levels. Transferrin saturation is reported by dividing value of serum iron by total iron binding capacity. |
| Secondary | Double-Blind Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs With Severity Greater Than or Equal to Grade 3 | Double-Blind Period: From the time of signing informed consent to Week 24 | AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug. A serious adverse event (SAE) is any untoward medical occurrence that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are AEs with an initial onset date during the on-treatment period or worsening from baseline and includes both serious \& non-serious TEAEs. Severity of AEs was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 4.03): grade 1: mild; grade 2: moderate; grade 3: severe or medically significant but not immediately life-threatening; grade 4: life threatening or disabling; grade 5: death related to AE. |
| Secondary | Double-Blind Period: Plasma Concentration of Mitapivat | Double-Blind Period: Pre-dose at Week 12; pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20 | |
| Secondary | Double-Blind Period: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of Mitapivat | Double-Blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20 | Area under the concentration-time curve from time zero to Tlast on dosing day, calculated using the linear-log trapezoidal rule. |
| Secondary | Double-Blind Period: Time of Last Quantifiable Concentration (Tlast) of Mitapivat | Double-Blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20 | |
| Secondary | Double-Blind Period: Maximum Observed Plasma Concentration (Cmax) of Mitapivat | Double-Blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20 | |
| Secondary | Double-Blind Period: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Mitapivat | Double-Blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 20 |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04770753/registered