Trial · NCT03938454
A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism
NCT03938454, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2025-03-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism. Trials, record NCT03938454. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03938454
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism
- NCT number
- NCT03938454
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Priapism
- Interventions
- Crizanlizumab
- First posted
- 2019-05-06
- Last updated
- 2026-01-13
- Results first posted
- 2025-03-10
- Limitations and caveats
- This was a single-arm trial in a disease where clinical history has significant variability.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in Priapic Events From Baseline to 26 Weeks | Baseline up to 26 weeks | A priapic event was defined as an unwanted or painful penile erection lasting at least 60 minutes. Priapic events were self-reported via an electronic reporting system, and data was collected throughout the study period. Number of priapic events was summarized at Baseline (adjusted for 26 weeks) and by 26 weeks, and percent reduction from adjusted Baseline by 26 weeks was summarized. |
| Secondary | Annualized Rate of Priapic Events | Baseline up to 26 and 52 weeks | A priapic event was defined as an unwanted or painful penile erection lasting at least 60 minutes. Priapic events were self-reported via an electronic reporting system, and data was collected throughout the study period. The annualized rate of events was defined as the total number of events for a participant occurring from the date of initial infusion to the last contact date of the Treatment Phase of the study x 365.25 divided by the number of days during that same time period. The calculation accounted for early dropouts or lost to follow-up by extrapolating the priapism events rate of every participant to 1 year. |
| Secondary | Number of Acute Priapic Events From Baseline to 26 and 52 Weeks | Baseline up to 26 and 52 weeks | An acute priapic event was defined as an unwanted, painful erection that lasted more than 4 hours and required a visit to the emergency room. |
| Secondary | Annualized Rate of Uncomplicated Vaso-occlusive Crises (VOCs) | Baseline up to 26 and 52 weeks | An uncomplicated VOC event was defined as an acute event of pain with no known cause for pain other than a VOC event; and requiring treatment with a parenteral or oral opioids or other parenteral analgesic; but was NOT classified as an acute chest syndrome, hepatic sequestration, splenic sequestration or priapism. Events included both healthcare and self-reported events. The annualized rate of events was defined as the total number of events for a participant occurring from the date of initial infusion to the last contact date of the Treatment Phase of the study x 365.25 divided by the number of days during that same time period. The calculation accounted for early dropouts or lost to follow-up by extrapolating the priapism events rate of every participant to 1 year. |
| Secondary | Annualized Rate of Complicated VOCs | Baseline up to 26 and 52 weeks | Complicated VOCs were defined as acute chest syndrome, hepatic sequestration, splenic sequestration, and acute priapism recorded by healthcare visit. The annualized rate of events was defined as the total number of events for a participant occurring from the date of initial infusion to the last contact date of the Treatment Phase of the study x 365.25 divided by the number of days during that same time period. The calculation accounted for early dropouts or lost to follow-up by extrapolating the priapism events rate of every participant to 1 year. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in Priapic Events From Baseline to 26 Weeks | Baseline up to 26 weeks | The full analysis set (FAS) included all enrolled participants to whom the study treatment was assigned regardless of whether or not they received at least one dose of study treatment or had at least one post-baseline assessment. | Percent change from baseline | MEDIAN |
| SECONDARY | Annualized Rate of Priapic Events | Baseline up to 26 and 52 weeks | The FAS included all enrolled participants to whom the study treatment was assigned regardless of whether or not they received at least one dose of study treatment or had at least one post-baseline assessment. | Events per year | MEDIAN |
| SECONDARY | Number of Acute Priapic Events From Baseline to 26 and 52 Weeks | Baseline up to 26 and 52 weeks | The FAS included all enrolled participants to whom the study treatment was assigned regardless of whether or not they received at least one dose of study treatment or had at least one post-baseline assessment. Only participants with Acute Priapic Events are included in this analysis. | Number of acute priapic events | MEDIAN |
| SECONDARY | Annualized Rate of Uncomplicated Vaso-occlusive Crises (VOCs) | Baseline up to 26 and 52 weeks | The FAS included all enrolled participants to whom the study treatment was assigned regardless of whether or not they received at least one dose of study treatment or had at least one post-baseline assessment. Only participants who had uncomplicated VOC events within the specified time frame were included in the analysis. | Events per year | MEDIAN |
| SECONDARY | Annualized Rate of Complicated VOCs | Baseline up to 26 and 52 weeks | The FAS included all enrolled participants to whom the study treatment was assigned regardless of whether or not they received at least one dose of study treatment or had at least one post-baseline assessment. Only participants who had complicated VOC events within the specified time frame were included in the analysis. | Events per year | MEDIAN |
| POST_HOC | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Associated With Infusion Related Reactions (Adverse Events of Special Interest) | Baseline up to 57 weeks | The Safety Analysis Set consisted of all participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Percent Change in Priapic Events From Baseline to 26 Weeks Without the Outlier | Baseline up to 26 weeks | The FAS included all enrolled participants to whom the study treatment was assigned regardless of whether or not they received at least one dose of study treatment or had at least one post-baseline assessment. Analysis was performed excluding one outlier participant, who had a large amount of data unreported. | Percent change from baseline | MEDIAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in Priapic Events From Baseline to 26 Weeks | Crizanlizumab 5 mg/kg | -61.3 | Inter-Quartile Range -80.1 to -17.3 | Percent change from baseline | |
| Annualized Rate of Priapic Events | Crizanlizumab 5 mg/kg | Annualized rate of priapic events by 26 weeks | 31.1 | Inter-Quartile Range 10.2 to 97.4 | Events per year |
| Annualized Rate of Priapic Events | Crizanlizumab 5 mg/kg | Annualized rate of priapic events by 52 weeks | 25.6 | Inter-Quartile Range 9.9 to 68.7 | Events per year |
| Number of Acute Priapic Events From Baseline to 26 and 52 Weeks | Crizanlizumab 5 mg/kg | Number of acute priapic events at Baseline | 7.0 | Full Range 2 to 11 | Number of acute priapic events |
| Number of Acute Priapic Events From Baseline to 26 and 52 Weeks | Crizanlizumab 5 mg/kg | Number of post-baseline acute priapic events by 26 weeks | 1.5 | Full Range 1 to 2 | Number of acute priapic events |
| Number of Acute Priapic Events From Baseline to 26 and 52 Weeks | Crizanlizumab 5 mg/kg | Number of post-baseline acute priapic events by 52 weeks | 1.0 | Full Range 1 to 2 | Number of acute priapic events |
| Annualized Rate of Uncomplicated Vaso-occlusive Crises (VOCs) | Crizanlizumab 5 mg/kg | Annualized rate of uncomplicated VOCs by 26 weeks | 4.1 | Inter-Quartile Range 3.9 to 8.0 | Events per year |
| Annualized Rate of Uncomplicated Vaso-occlusive Crises (VOCs) | Crizanlizumab 5 mg/kg | Annualized rate of uncomplicated VOCs by 52 weeks | 2.5 | Inter-Quartile Range 1.4 to 6.8 | Events per year |
| Annualized Rate of Complicated VOCs | Crizanlizumab 5 mg/kg | Annualized rate of complicated VOCs by 26 weeks | 1.9 | Inter-Quartile Range 1.9 to 1.9 | Events per year |
| Annualized Rate of Complicated VOCs | Crizanlizumab 5 mg/kg | Annualized rate of complicated VOCs by 52 weeks | 1.4 | Inter-Quartile Range 0.9 to 1.9 | Events per year |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Crizanlizumab 5 mg/kg | 36 | |
| Overall Study | COMPLETED | Crizanlizumab 5 mg/kg | 30 | |
| Overall Study | NOT COMPLETED | Crizanlizumab 5 mg/kg | 6 |
Source ClinicalTrials.gov
Adverse events32
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 | Sinus bradycardia | Cardiac disorders | Crizanlizumab 5 mg/kg | 2 | 36 | |
| other | Constipation | Gastrointestinal disorders | Crizanlizumab 5 mg/kg | 2 | 36 | |
| other | Diarrhoea | Gastrointestinal disorders | Crizanlizumab 5 mg/kg | 4 | 36 | |
| other | Vomiting | Gastrointestinal disorders | Crizanlizumab 5 mg/kg | 2 | 36 | |
| other | Chest discomfort | General disorders | Crizanlizumab 5 mg/kg | 2 | 36 | |
| other | Fatigue | General disorders | Crizanlizumab 5 mg/kg | 3 | 36 | |
| other | Non-cardiac chest pain | General disorders | Crizanlizumab 5 mg/kg | 2 | 36 | |
| other | Pyrexia | General disorders | Crizanlizumab 5 mg/kg | 6 | 36 | |
| other | COVID-19 | Infections and infestations | Crizanlizumab 5 mg/kg | 5 | 36 | |
| other | Infusion related reaction | Injury, poisoning and procedural complications | Crizanlizumab 5 mg/kg | 2 | 36 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Crizanlizumab 5 mg/kg | 0 | 36 |
| Total, other adverse events | Crizanlizumab 5 mg/kg | 26 | 36 |
| Total, serious adverse events | Crizanlizumab 5 mg/kg | 7 | 36 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03938454
GET https://conductscience.org/api/trials/v1/NCT03938454/results?page=2