Trial · NCT02666768
ACTIMMUNE in Intermediate Osteopetrosis
NCT02666768, Phase 2, Completed, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center; results first posted 2023-10-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ACTIMMUNE in Intermediate Osteopetrosis. Trials, record NCT02666768. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02666768
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ACTIMMUNE in Intermediate Osteopetrosis
- NCT number
- NCT02666768
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Conditions
- Osteopetrosis
- Interventions
- Interferon gamma-1b
- First posted
- 2016-01-28
- Last updated
- 2024-10-22
- Results first posted
- 2023-10-11
- Limitations and caveats
Limitations of this study include the small sample size, heterogeneity of the population, and difficulty obtaining endpoint measurements due to high withdrawal rate, all resulting in limited data for interpretation. Despite these limitations, this study provides information on the longest follow-up of treatment with interferon gamma-1b in this population and identified an approach to make the treatment tolerable.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Related Adverse Events CTCAE v4.0 Grade 3 or Higher | 12 months | Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 defines a Grade 4 event as having life-threatening consequences, and/or urgent intervention indicated. |
| Secondary | Percent Change From Baseline in Bone Mineral Density (BMD) | 6 months | BMD measured by peripheral quantitative computed tomography (pQCT) in bone area w/ BMD\<169mg/m3 |
| Secondary | Change From Baseline in White Blood Cell Count (WBC) | 6 months | |
| Secondary | Change From Baseline in Pain | 6 months | Survey name: RAND 36-Item Health Survey (Version 1.0) Scale name: Pain Scale range: 0-100; Higher score means less pain |
Source ClinicalTrials.gov
Outcomes4
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 Treatment Related Adverse Events CTCAE v4.0 Grade 3 or Higher | 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percent Change From Baseline in Bone Mineral Density (BMD) | 6 months | 1 participants withdrew due to flu-like side effects prior to 2nd pQCT measurement.~1 participant has no data for this measurement due to size of pQCT gantry. | percent change | MEDIAN |
| SECONDARY | Change From Baseline in White Blood Cell Count (WBC) | 6 months | Only 1 participant completed study to 12 months, so 6 month data are reported here. | x1000 cells/uL | MEDIAN |
| SECONDARY | Change From Baseline in Pain | 6 months | One participant was \<18 years old so did not complete the RAND 36-Item Health Survey | change in units on the pain scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group4
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 Treatment Related Adverse Events CTCAE v4.0 Grade 3 or Higher | Gamma Interferon-1b | 0 | Participants | ||
| Percent Change From Baseline in Bone Mineral Density (BMD) | Gamma Interferon-1b | 0 | Full Range -15 to 2 | percent change | |
| Change From Baseline in White Blood Cell Count (WBC) | Gamma Interferon-1b | -0.5 | Full Range -1.2 to 1 | x1000 cells/uL | |
| Change From Baseline in Pain | Gamma Interferon-1b | -0.8 | 95% Confidence Interval -2.0 to 0.3 | change in units on the pain scale |
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 | Gamma Interferon-1b | 5 | |
| Overall Study | COMPLETED | Gamma Interferon-1b | 1 | |
| Overall Study | NOT COMPLETED | Gamma Interferon-1b | 4 |
Source ClinicalTrials.gov
Adverse events16
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 | Neutropenia | Blood and lymphatic system disorders | Gamma Interferon-1b | 2 | 5 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Gamma Interferon-1b | 2 | 5 | 2 |
| other | Hyperglycemia | Endocrine disorders | Gamma Interferon-1b | 2 | 5 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Gamma Interferon-1b | 2 | 5 | 3 |
| other | Nausea | Gastrointestinal disorders | Gamma Interferon-1b | 3 | 5 | 3 |
| other | Fatigue | General disorders | Gamma Interferon-1b | 4 | 5 | 5 |
| other | Flu-like reaction | General disorders | Gamma Interferon-1b | 5 | 5 | 13 |
| other | Injection site reactions | General disorders | Gamma Interferon-1b | 3 | 5 | 11 |
| other | Sinusitis/sinus pain/sinus congestion | Infections and infestations | Gamma Interferon-1b | 2 | 5 | 4 |
| other | Bone pain - generalized | Musculoskeletal and connective tissue disorders | Gamma Interferon-1b | 2 | 5 | 2 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gamma Interferon-1b | 0 | 5 |
| Total, other adverse events | Gamma Interferon-1b | 5 | 5 |
| Total, serious adverse events | Gamma Interferon-1b | 0 | 5 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34056870 | 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/NCT02666768
GET https://conductscience.org/api/trials/v1/NCT02666768/registered