Trial · NCT04930445
Oxbryta® Product Registry An Observational Study Designed to Evaluate the Effect of Oxbryta in Individuals With SCD
NCT04930445, Terminated, Pfizer; results first posted 2025-12-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Oxbryta® Product Registry An Observational Study Designed to Evaluate the Effect of Oxbryta in Individuals With SCD. Trials, record NCT04930445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04930445
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oxbryta® Product Registry An Observational Study Designed to Evaluate the Effect of Oxbryta in Individuals With SCD
- NCT number
- NCT04930445
- Status
- Terminated
- Enrollment
- 265 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Sickle Cell Disease
- Interventions
- Oxbryta® (voxelotor) 500mg Tablets
- First posted
- 2021-06-18
- Last updated
- 2025-12-31
- Results first posted
- 2025-12-31
- Limitations and caveats
For outcome measure 9, the terminology used for other: small, medium, and large were entered by sites to describe the severity or amount but is not clinically precise and should be interpreted cautiously.
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used. |
| Primary | Change in Percent Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used. |
| Primary | Change in Absolute Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used. |
| Primary | Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used. Abbreviations used: overall number of participants analyzed=N and Number analyzed= n |
| Primary | Change in Iron Overload (Ferritin Levels) From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used. |
| Primary | Change in Iron Overload as Measured by T2-weighted Magnetic Resonance Imaging (MRI) From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) up to 60 months post-Oxbryta | The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used. |
| Primary | Change in Serum Creatinine Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used. |
| Primary | Change in Albumin Creatinine Ratio (ACR) From Pre-Oxbryta Treatment (Baseline) Through Month 54 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 months post-Oxbryta | The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used. |
| Primary | Number of Participants According to Hemoglobinuria Results Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | Hemoglobinuria was defined as urine dipstick results positive for blood +1 or greater and \<=2 red blood cells (RBC) by high power field. Number of participants according to hemoglobinuria results (none/negative, trace, 1+, 2+, 3+, other: large, moderate, small, small=0-3, hereditary persistence of fetal hemoglobin \[HPF\], missing) was reported in this outcome measure. Small corresponded to trace or 1+ on dipstick, medium indicated 2+, large indicated 3+ or higher on dipstick. The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used. |
| Primary | Change in Serum Cystatin C Results From Pre-Oxbryta Treatment (Baseline) Through Month 30 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 12, 18, 24, 30 months post-Oxbryta | The pre-Oxbryta (baseline) value was the latest measurement on or prior to the first dose of Oxbryta. Post-Oxbryta value was the measurement for multiple assessments at the same specific visit, the average was used. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified time-points. | Grams per deciliter (g/dL) | MEAN |
| PRIMARY | Change in Percent Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified time-points. | Percentage of reticulocytes | MEAN |
| PRIMARY | Change in Absolute Reticulocyte Count From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified time-points. | 10^9 cells/Liter | MEAN |
| PRIMARY | Change in Bilirubin (Total, Direct and Indirect) Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of inform consent date). Here, 'N'=number of participants evaluable for this outcome measure and 'n'=participants evaluable for specified time-points. Indirect bilirubin data for month 54 and 60 was not collected as data collection was not mandatory for laboratory parameters since it is a non-interventional study. | milligrams per deciliter (mg/dL) | MEAN |
| PRIMARY | Change in Iron Overload (Ferritin Levels) From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified time-points. | Micrograms per liter | MEAN |
| PRIMARY | Change in Iron Overload as Measured by T2-weighted Magnetic Resonance Imaging (MRI) From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) up to 60 months post-Oxbryta | No data was not collected for this outcome measure as the information regarding iron overload as measured by T2-weighted MRI was not available in the medical record for any of the participants. | ||
| PRIMARY | Change in Serum Creatinine Level From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified time-points. | milligrams per deciliter (mg/dL) | MEAN |
| PRIMARY | Change in Albumin Creatinine Ratio (ACR) From Pre-Oxbryta Treatment (Baseline) Through Month 54 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified time-points. | Milligram per gram | MEAN |
| PRIMARY | Number of Participants According to Hemoglobinuria Results Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change in Serum Cystatin C Results From Pre-Oxbryta Treatment (Baseline) Through Month 30 Post-Oxbryta | Pre-Oxbryta (baseline) 3, 6, 12, 18, 24, 30 months post-Oxbryta | FAS included all participants who met the inclusion/exclusion criteria and signed the inform consent, including screen failures (participants who did not receive Oxbryta within 6 months of the inform consent date). Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies participants evaluable for specified time-points. | milligrams per liter (mg/L) | MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group523
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | All Participants | 3 months Post-Oxbryta | 0.5 | Standard Deviation 1.33 | Grams per deciliter (g/dL) |
| Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | All Participants | 6 months Post-Oxbryta | 0.6 | Standard Deviation 1.47 | Grams per deciliter (g/dL) |
| Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | All Participants | 9 months Post-Oxbryta | 0.5 | Standard Deviation 1.45 | Grams per deciliter (g/dL) |
| Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | All Participants | 12 months Post-Oxbryta | 0.6 | Standard Deviation 1.36 | Grams per deciliter (g/dL) |
| Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | All Participants | 18 months Post-Oxbryta | 0.7 | Standard Deviation 1.35 | Grams per deciliter (g/dL) |
| Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | All Participants | 24 months Post-Oxbryta | 0.6 | Standard Deviation 1.46 | Grams per deciliter (g/dL) |
| Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | All Participants | 30 months Post-Oxbryta | 0.5 | Standard Deviation 1.62 | Grams per deciliter (g/dL) |
| Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | All Participants | 36 months Post-Oxbryta | 0.6 | Standard Deviation 1.62 | Grams per deciliter (g/dL) |
| Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | All Participants | 42 months Post-Oxbryta | 0.4 | Standard Deviation 1.48 | Grams per deciliter (g/dL) |
| Change in Hemoglobin From Pre-Oxbryta Treatment (Baseline) Through Month 60 Post-Oxbryta | All Participants | 48 months Post-Oxbryta | 0.7 | Standard Deviation 1.47 | Grams per deciliter (g/dL) |
1 to 10 of 523Source ClinicalTrials.gov
See all 523 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Participants | 265 | |
| Overall Study | Treated | All Participants | 260 | |
| Overall Study | COMPLETED | All Participants | 0 | |
| Overall Study | NOT COMPLETED | All Participants | 265 |
Source ClinicalTrials.gov
Adverse events130
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | All Participants | 1 | 260 | |
| other | Haemolysis | Blood and lymphatic system disorders | All Participants | 1 | 260 | |
| other | Sickle cell anaemia with crisis | Blood and lymphatic system disorders | All Participants | 154 | 260 | |
| other | Atrial thrombosis | Cardiac disorders | All Participants | 1 | 260 | |
| other | Mitral valve incompetence | Cardiac disorders | All Participants | 1 | 260 | |
| other | Sickle cell anaemia | Congenital, familial and genetic disorders | All Participants | 9 | 260 | |
| other | Ophthalmic artery aneurysm | Eye disorders | All Participants | 1 | 260 | |
| other | Retinopathy | Eye disorders | All Participants | 3 | 260 | |
| other | Abdominal pain | Gastrointestinal disorders | All Participants | 30 | 260 | |
| other | Abdominal pain upper | Gastrointestinal disorders | All Participants | 1 | 260 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | 6 | 260 |
| Total, other adverse events | All Participants | 185 | 260 |
| Total, serious adverse events | All Participants | 150 | 260 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41701977 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04930445
GET https://conductscience.org/api/trials/v1/NCT04930445/registered?page=2