Trial · NCT02584608
Use of ACTIMMUNE in Patients With ADO2
NCT02584608, Phase 2, Completed, Indiana University; results first posted 2021-01-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of ACTIMMUNE in Patients With ADO2. Trials, record NCT02584608. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02584608
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of ACTIMMUNE in Patients With ADO2
- NCT number
- NCT02584608
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Indiana University
- Conditions
- Autosomal Dominant Osteopetrosis Type 2
- Interventions
- ACTIMMUNE
- First posted
- 2015-10-22
- Last updated
- 2021-01-08
- Results first posted
- 2021-01-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Bone Resorption Markers From Baseline to 14 Weeks. | baseline, 14 weeks | Evaluate for changes in bone resorption markers including CTX, NTX/creatinine ratio between baseline and 14 weeks |
| Secondary | Change in Bone Turnover Markers Between After Completion of 6-12 Weeks of Treatment | 6-12 weeks | Evaluate for changes in bone turnover markers including TRAP5b, NTX, CTX/TRAP5b ratio after 6-12 weeks of treatment. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in Bone Resorption Markers From Baseline to 14 Weeks. | baseline, 14 weeks | All subjects | percentage of change | MEAN |
| SECONDARY | Change in Bone Turnover Markers Between After Completion of 6-12 Weeks of Treatment | 6-12 weeks | all subjects | percentage of change | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Bone Resorption Markers From Baseline to 14 Weeks. | Treatment | Percent change of CTX | 2.2 | Full Range -35.7 to 90.5 | percentage of change |
| Changes in Bone Resorption Markers From Baseline to 14 Weeks. | Treatment | Percent change of NTX/creatinine ratio | -2.1 | Full Range -50.5 to 55.5 | percentage of change |
| Change in Bone Turnover Markers Between After Completion of 6-12 Weeks of Treatment | Treatment | TRAP5B | -15.34 | Full Range -57.07 to 13.1 | percentage of change |
| Change in Bone Turnover Markers Between After Completion of 6-12 Weeks of Treatment | Treatment | NTX | -2.09 | Full Range -50.51 to 55.54 | percentage of change |
| Change in Bone Turnover Markers Between After Completion of 6-12 Weeks of Treatment | Treatment | CTX/TRAP5b ratio | 26.31 | Full Range -35.91 to 144.57 | percentage of change |
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 | Treatment | 12 | |
| Overall Study | COMPLETED | Treatment | 12 | |
| Overall Study | NOT COMPLETED | Treatment | 0 |
Source ClinicalTrials.gov
Adverse events25
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 | Headache | Nervous system disorders | Treatment | 10 | 12 | |
| other | Fatigue | Nervous system disorders | Treatment | 9 | 12 | |
| other | nausea | Gastrointestinal disorders | Treatment | 9 | 12 | |
| other | flu like symptoms | Product Issues | Treatment | 8 | 12 | |
| other | myalgia | Musculoskeletal and connective tissue disorders | Treatment | 7 | 12 | |
| other | white blood cell decreased | Blood and lymphatic system disorders | Treatment | 6 | 12 | |
| other | arthralgia | Musculoskeletal and connective tissue disorders | Treatment | 5 | 12 | |
| other | diarrhea | Gastrointestinal disorders | Treatment | 5 | 12 | |
| other | neutrophil count decreased | Blood and lymphatic system disorders | Treatment | 5 | 12 | |
| other | vomiting | Gastrointestinal disorders | Treatment | 5 | 12 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment | 0 | 12 |
| Total, other adverse events | Treatment | 10 | 12 |
| Total, serious adverse events | Treatment | 0 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30889272 | RESULT |
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/NCT02584608
GET https://conductscience.org/api/trials/v1/NCT02584608/events?page=2