Trial · NCT00944749
Horse ATG/CsA in Aplastic Anemia Patients Unresponsive to or With a Suboptimal Response to Rabbit ATG/CsA Treatment
NCT00944749, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2017-02-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Horse ATG/CsA in Aplastic Anemia Patients Unresponsive to or With a Suboptimal Response to Rabbit ATG/CsA Treatment. Trials, record NCT00944749. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00944749
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Horse ATG/CsA in Aplastic Anemia Patients Unresponsive to or With a Suboptimal Response to Rabbit ATG/CsA Treatment
- NCT number
- NCT00944749
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Anemia, Aplastic, Anemia, Hypoplastic
- Interventions
- h-ATG (ATGAM ), Cyclosporine (Gengraf )
- First posted
- 2009-07-23
- Last updated
- 2021-03-23
- Results first posted
- 2017-02-23
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Complete Response at 3 Months. | 3-months | The primary endpoint was hematologic response at 3 months, defined as no longer meeting criteria for Severe Aplastic Anemia (SAA) defined as bone marrow cellularity of less than 30% and severe pancytopenia with at least two of the following peripheral blood count criteria: (i) absolute neutrophil count less than 0.5×109/L; (ii) absolute reticulocyte count less than 60×109/L; and (iii) platelet count less than 20×109/L. A complete response was defined as absolute neutrophil count (ANC) above 1.0×109/L, Hgb \> 10 g/dL, and platelet count \> 100×109/L. A partial response was defined as a hematologic response that was not sufficient for a complete response. |
| Primary | Number of Participants With Complete Response at 3 Months. | 3 months | The primary endpoint was hematologic response at 3 months, defined as no longer meeting criteria for Severe Aplastic Anemia (SAA). A complete response was defined as absolute neutrophil count (ANC) above 1.0×109/L, Hgb \> 10 g/dL, and platelet count \> 100×109/L. A partial response was defined as a hematologic response that was not sufficient for a complete response. In subjects with a non-robust hematologic response at 3 months, improvement in one or more of the listed peripheral blood parameter (a,b,c) were recorded as a response: a) ANC - if baseline ANC below 0.5×109/L, increase in ANC by \> 0.3×109/L, if baseline ANC above 0.5×109/L, any increase in ANC by \> 0.5×109/L of blood; (b) platelets - if baseline platelet count \< 50×109/L, any increase in platelet count by \> 20×109/L of blood; c) hemoglobin - any increase in hemoglobin by 1.5 g/dl of blood in transfusion-independent patients and in absolute reticulocyte count to \> 60×109/L of blood in transfusion-dependent patients. |
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 | Number of Participants With Complete Response at 3 Months. | 3-months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Complete Response at 3 Months. | 3 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
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 Complete Response at 3 Months. | Single Arm | 0 | Participants | ||
| Number of Participants With Complete Response at 3 Months. | Single Arm | 2 | 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 | Single Arm | 23 | |
| Overall Study | COMPLETED | Single Arm | 22 | |
| Overall Study | NOT COMPLETED | Single Arm | 1 |
Source ClinicalTrials.gov
Adverse events7
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 | Rhinorrhea | Infections and infestations | Single Arm | 1 | 23 | 1 |
| serious | Hospitalization - Neutropenic fever | Blood and lymphatic system disorders | Single Arm | 7 | 23 | |
| serious | Hospitalization - Infection/ Febrile neutropenia | Infections and infestations | Single Arm | 2 | 23 | |
| serious | Hospitalization - Hemorrhage/ bleeding | Blood and lymphatic system disorders | Single Arm | 1 | 23 | |
| serious | Death - Hemorrhage/ bleeding | Blood and lymphatic system disorders | Single Arm | 1 | 23 | |
| serious | Hospitalization - Infection | Infections and infestations | Single Arm | 9 | 23 | |
| serious | Hospitalization - Gastrointestinal | Gastrointestinal disorders | Single Arm | 1 | 23 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single Arm | ||
| Total, other adverse events | Single Arm | 1 | 23 |
| Total, serious adverse events | Single Arm | 14 | 23 |
Source ClinicalTrials.gov
Papers5
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/NCT00944749
GET https://conductscience.org/api/trials/v1/NCT00944749/registered