Trial · NCT00001962
A Study to Determine Whether Therapy With Daclizumab Will Benefit Patients With Bone Marrow Failure
NCT00001962, Phase 2, Terminated, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2015-05-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Determine Whether Therapy With Daclizumab Will Benefit Patients With Bone Marrow Failure. Trials, record NCT00001962. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00001962
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Determine Whether Therapy With Daclizumab Will Benefit Patients With Bone Marrow Failure
- NCT number
- NCT00001962
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Aplastic Anemia, Pure Red Cell Aplasia, Diamond Blackfan Anemia
- Interventions
- Daclizumab
- First posted
- 2000-01-19
- Last updated
- 2021-07-09
- Results first posted
- 2015-05-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Hematologic Response Following Daclizumab in Patients With Moderate Aplastic Anemia (MAA) and Pure Red Cell Aplasia (PRCA). | 3 months | Number of participants with hematologic response at 3 months following Daclizumab, 1 mg/kg, will be given for a total of 5 intravenous infusions to subjects diagnosed with moderate aplastic anemia (MAA), pure red cell aplasia (PRCA), Diamond Blackfan anemia (DBA), relapse and refractory severe aplastic anemia (SAA) will receive treatment. A complete hematologic response will be considered an achievement of normal blood counts. A partial response was defined as any response less than a complete response. The primary endpoint was a hematologic response in at least one affected peripheral blood count parameter, as determined by 3 separate measurements in the first 12 weeks after completion of the infusion. |
| Secondary | Number of Participants That no Longer Required Blood Transfusion | 5 years | Number of participants that no longer required blood transfusion after receiving Daclizumab, 1 mg/kg, for a total of 5 intravenous infusions to subjects diagnosed with moderate aplastic anemia (MAA), pure red cell aplasia (PRCA), Diamond Blackfan anemia (DBA), relapse and refractory severe aplastic anemia (SAA) will receive treatment. |
| Secondary | Overall Survival | 5 years | Overall Survival at end of study after receiving Daclizumab, 1 mg/kg, for a total of 5 intravenous infusions to subjects diagnosed with moderate aplastic anemia (MAA), pure red cell aplasia (PRCA), Diamond Blackfan anemia (DBA), relapse and refractory severe aplastic anemia (SAA) will receive treatment. |
Source ClinicalTrials.gov
Outcomes3
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 Hematologic Response Following Daclizumab in Patients With Moderate Aplastic Anemia (MAA) and Pure Red Cell Aplasia (PRCA). | 3 months | The daclizumab hematologic response was evaluated for subjects diagnosed with moderate aplastic anemia (MAA) and pure red cell aplasia (PRCA). The Diamond Blackfan arm was closed due to lack of accrual. Relapse and Refractory Severe Aplastic Anemia (SAA) was closed to lack of efficacy. | participants | NUMBER |
| SECONDARY | Number of Participants That no Longer Required Blood Transfusion | 5 years | This was evaluated for subjects diagnosed with moderate aplastic anemia (MAA) and pure red cell aplasia (PRCA). The Diamond Blackfan anemia arm was closed due to the lack of accrual. The Relapse and Refractory Severe Aplastic Anemia (SAA) was closed due to lack of efficacy. | participants | NUMBER |
| SECONDARY | Overall Survival | 5 years | This was evaluated for subjects diagnosed with moderate aplastic anemia (MAA) and pure red cell aplasia (PRCA). The Diamond Blackfan anemia arm was closed due to the lack of accrual. The Relapse and Refractory Severe Aplastic Anemia (SAA) was closed due to lack of efficacy. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
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 Hematologic Response Following Daclizumab in Patients With Moderate Aplastic Anemia (MAA) and Pure Red Cell Aplasia (PRCA). | Daclizumab in Participants With a Bone Marrow Failure Syndrome | MAA Complete response | 6 | participants | |
| Number of Participants With Hematologic Response Following Daclizumab in Patients With Moderate Aplastic Anemia (MAA) and Pure Red Cell Aplasia (PRCA). | Daclizumab in Participants With a Bone Marrow Failure Syndrome | MAA Partial response | 13 | participants | |
| Number of Participants With Hematologic Response Following Daclizumab in Patients With Moderate Aplastic Anemia (MAA) and Pure Red Cell Aplasia (PRCA). | Daclizumab in Participants With a Bone Marrow Failure Syndrome | MAA No response | 26 | participants | |
| Number of Participants With Hematologic Response Following Daclizumab in Patients With Moderate Aplastic Anemia (MAA) and Pure Red Cell Aplasia (PRCA). | Daclizumab in Participants With a Bone Marrow Failure Syndrome | PRCA Complete response | 6 | participants | |
| Number of Participants With Hematologic Response Following Daclizumab in Patients With Moderate Aplastic Anemia (MAA) and Pure Red Cell Aplasia (PRCA). | Daclizumab in Participants With a Bone Marrow Failure Syndrome | PRCA Partial response | 4 | participants | |
| Number of Participants With Hematologic Response Following Daclizumab in Patients With Moderate Aplastic Anemia (MAA) and Pure Red Cell Aplasia (PRCA). | Daclizumab in Participants With a Bone Marrow Failure Syndrome | PRCA No response | 17 | participants | |
| Number of Participants That no Longer Required Blood Transfusion | Daclizumab in Participants With a Bone Marrow Failure Syndrome | MAA | 7 | participants | |
| Number of Participants That no Longer Required Blood Transfusion | Daclizumab in Participants With a Bone Marrow Failure Syndrome | PRCA | 28 | participants | |
| Overall Survival | Daclizumab in Participants With a Bone Marrow Failure Syndrome | Deaths | 7 | Participants | |
| Overall Survival | Daclizumab in Participants With a Bone Marrow Failure Syndrome | Alive | 65 | 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 | Daclizumab in Bone Marrow Failure Syndromes | 100 | |
| Overall Study | COMPLETED | Daclizumab in Bone Marrow Failure Syndromes | 72 | |
| Overall Study | NOT COMPLETED | Daclizumab in Bone Marrow Failure Syndromes | 28 |
Source ClinicalTrials.gov
Adverse events96
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 | shortness of breath | Infections and infestations | Daclizumab in Participants With a Bone Marrow Failure Syndrome | 9 | 100 | 9 |
| other | headache | General disorders | Daclizumab in Participants With a Bone Marrow Failure Syndrome | 11 | 100 | 12 |
| other | diarrhea | Gastrointestinal disorders | Daclizumab in Participants With a Bone Marrow Failure Syndrome | 7 | 100 | 7 |
| other | pain | Musculoskeletal and connective tissue disorders | Daclizumab in Participants With a Bone Marrow Failure Syndrome | 6 | 100 | 6 |
| other | dry skin | Skin and subcutaneous tissue disorders | Daclizumab in Participants With a Bone Marrow Failure Syndrome | 1 | 100 | 1 |
| other | edema | Cardiac disorders | Daclizumab in Participants With a Bone Marrow Failure Syndrome | 14 | 100 | 14 |
| other | fatigue | General disorders | Daclizumab in Participants With a Bone Marrow Failure Syndrome | 5 | 100 | 5 |
| other | fever | General disorders | Daclizumab in Participants With a Bone Marrow Failure Syndrome | 4 | 100 | 4 |
| other | eczema | Skin and subcutaneous tissue disorders | Daclizumab in Participants With a Bone Marrow Failure Syndrome | 1 | 100 | 1 |
| other | blurred vision | Eye disorders | Daclizumab in Participants With a Bone Marrow Failure Syndrome | 3 | 100 | 3 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daclizumab in Participants With a Bone Marrow Failure Syndrome | 7 | 100 |
| Total, other adverse events | Daclizumab in Participants With a Bone Marrow Failure Syndrome | 40 | 100 |
| Total, serious adverse events | Daclizumab in Participants With a Bone Marrow Failure Syndrome | 9 | 100 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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/NCT00001962
GET https://conductscience.org/api/trials/v1/NCT00001962/events?page=2