Trial · NCT02531867
Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan
NCT02531867, Phase 4, Completed, Alexion Pharmaceuticals, Inc.; results first posted 2017-05-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan. Trials, record NCT02531867. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02531867
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post-approval Clinical Study of Asfotase Alfa Treatment for Patients With Hypophosphatasia (HPP) in Japan
- NCT number
- NCT02531867
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 13 participants, actual
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Conditions
- Hypophosphatasia
- Interventions
- Asfotase Alfa
- First posted
- 2015-08-25
- Last updated
- 2017-05-08
- Results first posted
- 2017-05-08
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) Including Injection Site Reactions (ISRs) and Injection Associated Reactions (IARs) | Events that occurred between the first dose of asfotase alfa and the completion of the patient's last visit, which was up to 5 months. | Adverse events are any unwanted adverse medical occurrence in patients who are treated with a medicinal drug, whether or not considered drug-related. This includes events observed in patients administered with asfotase alfa between the first dose of asfotase alfa and the completion of patient's last visit for the clinical study. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) Including Injection Site Reactions (ISRs) and Injection Associated Reactions (IARs) | Events that occurred between the first dose of asfotase alfa and the completion of the patient's last visit, which was up to 5 months. | All patients who met all of the inclusion and none of the exclusion criteria were defined as the enrolled population, which was also the analysis population.The safety set comprised all patients who received at least 1 dose of the investigational drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) Including Injection Site Reactions (ISRs) and Injection Associated Reactions (IARs) | Overall Study | Number of Patients with AEs | 9 | Participants | |
| Number of Participants With Adverse Events (AEs) Including Injection Site Reactions (ISRs) and Injection Associated Reactions (IARs) | Overall Study | Number of Patients with ISRs | 2 | Participants | |
| Number of Participants With Adverse Events (AEs) Including Injection Site Reactions (ISRs) and Injection Associated Reactions (IARs) | Overall Study | Number of Patients with IARs | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Overall Study | 13 | |
| Overall Study | COMPLETED | Overall Study | 13 | |
| Overall Study | NOT COMPLETED | Overall Study | 0 |
Source ClinicalTrials.gov
Adverse events12
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 | Enterocolitis | Gastrointestinal disorders | Overall Study | 1 | 13 | 1 |
| other | Injection site bruising | General disorders | Overall Study | 1 | 13 | 1 |
| other | Injection site erythema | General disorders | Overall Study | 1 | 13 | 3 |
| other | Injection site induration | General disorders | Overall Study | 1 | 13 | 1 |
| other | Bronchitis | Infections and infestations | Overall Study | 1 | 13 | 1 |
| other | Conjunctivitis viral | Infections and infestations | Overall Study | 1 | 13 | 1 |
| other | Nasopharyngitis | Infections and infestations | Overall Study | 2 | 13 | 3 |
| other | Upper respiratory tract infection | Infections and infestations | Overall Study | 2 | 13 | 5 |
| other | Viral rash | Infections and infestations | Overall Study | 1 | 13 | 1 |
| other | Feeding tube complicatino | Injury, poisoning and procedural complications | Overall Study | 1 | 13 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Overall Study | ||
| Total, other adverse events | Overall Study | 9 | 13 |
| Total, serious adverse events | Overall Study | 0 | 13 |
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/NCT02531867
GET https://conductscience.org/api/trials/v1/NCT02531867/registered