Trial · NCT03548220
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving a Hemoglobin (Hb) Response (HR) | Baseline, Weeks 16, 20, 24 | Full analysis set included all participants who were randomized. | percentage of participants | NUMBER |
| SECONDARY | Average Change From Baseline in Hb Concentration at Weeks 16, 20 and 24 | Baseline, Weeks 16, 20, 24 | Full analysis set included all participants who were randomized. | grams per liter (g/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Maximum Change From Baseline in Hb Concentration | Baseline, up to Week 24 | Full analysis set included all participants who were randomized. Overall number of participants analyzed is the number of participants evaluated for the outcome measure. | g/L | MEAN |
| SECONDARY | Time to Achieve an Increase in Hb Concentration of 1.5 g/dL or More | Baseline, up to Week 24 | Full analysis set included all participants who were randomized. Overall number of participants analyzed is the number of participants evaluated for the outcome measure. | weeks | MEAN |
| SECONDARY | Average Change From Baseline in Indirect Bilirubin at Weeks 16, 20 and 24 | Baseline, Weeks 16, 20, 24 | Full analysis set included all participants who were randomized. Overall number of participants analyzed is the number of participants evaluated for the outcome measure. | micromoles per liter (μmol/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Average Change From Baseline in Lactic Acid Dehydrogenase (LDH) at Weeks 16, 20 and 24 | Baseline, Weeks 16, 20, 24 | Full analysis set included all participants who were randomized. Overall number of participants analyzed is the number of participants evaluated for the outcome measure. | units per litre (U/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Average Change From Baseline in Haptoglobin at Weeks 16, 20 and 24 | Baseline, Weeks 16, 20, 24 | Full analysis set included all participants who were randomized. | g/L | LEAST_SQUARES_MEAN |
| SECONDARY | Average Change From Baseline in Reticulocyte Percentages at Weeks 16, 20 and 24 | Baseline, Weeks 16, 20, 24 | Full analysis set included all participants who were randomized. | Reticulocyte percentages | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Pyruvate Kinase Deficiency Diary (PKDD) Score at Week 24 | Baseline, Week 24 | Full analysis set included all participants who were randomized. Overall number of participants analyzed is the number of participants evaluated for the outcome measure. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Pyruvate Kinase Deficiency Impact Assessment (PKDIA) Score at Week 24 | Baseline, Week 24 | Full analysis set included all participants who were randomized. Overall number of participants analyzed is the number of participants evaluated for the outcome measure. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Adverse Events | From signing of informed consent form to the end of study, including follow-up (up to Day 197) | Safety analysis set included all participants who received at least 1 dose of study treatment. | percentage of participants | NUMBER |
| SECONDARY | Area Under the Curve From Time 0 to the Last Quantifiable Concentration [AUC(0-last)] for AG-348 at Week 12 | Pre-dose, 30 minutes and 1, 2, 4 and 8 hours post-dose on Day 85 (Week 12) | Pharmacokinetic analysis population consisted of all participants who were enrolled and received a dose of study medication (mitapivat) with at least 1 non-zero pharmacokinetic plasma concentration of mitapivat at the Week 12 visit. Overall number of participants analyzed is the number of participants evaluated for the outcome measure. | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) for AG-348 | Pre-dose, 30 minutes and 1, 2, 4 and 8 hours post-dose on Day 85 (Week 12) | Pharmacokinetic analysis population consisted of all participants who were enrolled and received a dose of study medication (mitapivat) with at least 1 non-zero pharmacokinetic plasma concentration of mitapivat at the Week 12 visit. Overall number of participants analyzed is the number of participants evaluated for the outcome measure. | Nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Time to Cmax (Tmax) for AG-348 | Pre-dose, 30 minutes and 1, 2, 4 and 8 hours post-dose on Day 85 (Week 12) | Pharmacokinetic analysis population consisted of all participants who were enrolled and received a dose of study medication (mitapivat) with at least 1 non-zero pharmacokinetic plasma concentration of mitapivat at the Week 12 visit. Overall number of participants analyzed is the number of participants evaluated for the outcome measure. | hours (h) | MEDIAN |
| SECONDARY | Time to Last Measurable Concentration (Tlast) for AG-348 | Pre-dose, 30 minutes and 1, 2, 4 and 8 hours post-dose on Day 85 (Week 12) | Pharmacokinetic analysis population consisted of all participants who were enrolled and received a dose of study medication (mitapivat) with at least 1 non-zero pharmacokinetic plasma concentration of mitapivat at the Week 12 visit. Overall number of participants analyzed is the number of participants evaluated for the outcome measure. | hours (h) | GEOMETRIC_MEAN |
| SECONDARY | Exposure-Response Relationship of Adverse Event (Hot Flush) and AG-348 Concentration and Relevant AG-348 Pharmacokinetic Parameters | From first dose of mitapivat to the end of study, including follow-up (up to Day 197) | Safety Set: Participants who were administered the study drug. Participants who received mitapivat in studies: study AG348-C-003 (NCT02476916): 52 participants; study AG348-C-006 (NCT03548220): 40 participants; study AG348-C-007 (NCT03559699): 27 participants; and study AG348-C-011 (NCT03853798): 36 participants, were pooled for the analysis of this outcome measure. | Percent probability | MEAN |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Adverse Events of Special Interest (AESI) | Through 4 weeks after last dose (approximately Week 31) | |||
| OTHER_PRE_SPECIFIED | Change From Baseline in Bone Mineral Density Z-Score at Week 24 | Baseline, Week 24 | |||
| OTHER_PRE_SPECIFIED | Change From Baseline in Bone Mineral Density T-Score at Week 24 | Baseline, Week 24 | |||
| SECONDARY | Exposure-Response Relationship Between Safety Parameters (Sex Hormone in Male Subjects) and AG-348 Concentration and Relevant AG-348 Pharmacokinetic Parameters | Baseline, Week 24 | Safety Set: Participants who were administered the study drug. Male participants who received mitapivat in studies: study AG348-C-003 (NCT02476916): 32 participants; study AG348-C-006 (NCT03548220):15 participants; study AG348-C-007 (NCT03559699): 7 participants; and study AG348-C-011 (NCT03853798): 14 participants were pooled for analysis of this outcome measure. | Percent change | MEAN |
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/NCT03548220/outcomes