Trial · NCT04770753
Outcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | FAS included all participants who were randomized. | Percentage of participants | NUMBER |
| 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 | FAS included all participants who were randomized. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | score on a scale | LEAST_SQUARES_MEAN |
| 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 | FAS included all participants who were randomized. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | Gram per Liter (g/L) | LEAST_SQUARES_MEAN |
| 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 | FAS included all participants who were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Double-Blind Period: Change From Baseline in Indirect Bilirubin at Week 24 | Double-Blind Period: Baseline, Week 24 | FAS included all participants who were randomized. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | Micromole per Liter (umol/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Double-Blind Period: Change From Baseline in Lactate Dehydrogenase (LDH) at Week 24 | Double-Blind Period: Baseline, Week 24 | FAS included all participants who were randomized. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | Units per Liter (U/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Double-Blind Period: Change From Baseline in Haptoglobin at Week 24 | Double-Blind Period: Baseline, Week 24 | FAS included all participants who were randomized. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | Gram per Liter (g/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Double-Blind Period: Change From Baseline in Reticulocytes at Week 24 | Double-Blind Period: Baseline, Week 24 | FAS included all participants who were randomized. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | 10^9 cells per liter (10^9 cells/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Double-Blind Period: Change From Baseline in Erythropoietin at Week 24 | Double-Blind Period: Baseline, Week 24 | FAS included all participants who were randomized. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | International units per Liter (IU/L) | LEAST_SQUARES_MEAN |
| 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 | FAS included all participants who were randomized. | percentage of participants | NUMBER |
| 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 | FAS included all participants who were randomized. | percentage of participants | NUMBER |
| SECONDARY | Double-Blind Period: Change From Baseline in the 6-minute Walk Test (6MWT) Distance at Week 24 | Double-Blind Period: Baseline, Week 24 | FAS included all participants who were randomized. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | Meters | LEAST_SQUARES_MEAN |
| SECONDARY | Double-Blind Period: Change From Baseline in Serum Ferritin at Week 24 | Double-Blind Period: Baseline, Week 24 | FAS included all participants who were randomized. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | Microgram/Liter (mcg/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Double-Blind Period: Change From Baseline in Transferrin Saturation (TSAT) at Week 24 | Double-Blind Period: Baseline, Week 24 | FAS included all participants who were randomized. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | Ratio | LEAST_SQUARES_MEAN |
| 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 | Safety Analysis Set (SAS) includes all participants who had received at least 1 dose of study treatment. Participants were classified according to the treatment received. If a participant was randomized to placebo and received at least 1 dose of mitapivat in the Double-blind Period, then the participant was classified to the mitapivat arm. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Pharmacokinetic (PK) Analysis Set included a subset of the safety analysis set including all subjects with at least 1 mitapivat plasma concentration measurement ≥LLQ (lower limit of quantification). Number analyzed signifies those participants who were evaluable at specified time point. | nanograms per milliliter (ng/mL) | MEAN |
| 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 | Pharmacokinetic (PK) Analysis Set included a subset of the safety analysis set including all subjects with at least 1 mitapivat plasma concentration measurement ≥LLQ. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | Hours*nanogram per milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| 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 | Pharmacokinetic (PK) Analysis Set included a subset of the safety analysis set including all subjects with at least 1 mitapivat plasma concentration measurement ≥LLQ. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | hours | MEDIAN |
| 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 | Pharmacokinetic (PK) Analysis Set included a subset of the safety analysis set including all subjects with at least 1 mitapivat plasma concentration measurement ≥LLQ. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | ng/mL | GEOMETRIC_MEAN |
| 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 | Pharmacokinetic (PK) Analysis Set included a subset of the safety analysis set including all subjects with at least 1 mitapivat plasma concentration measurement ≥LLQ. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | Hours | MEDIAN |
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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