Trial · NCT00901199
Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload
NCT00901199, Phase 2, Completed, Elliott Vichinsky; results first posted 2021-08-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload. Trials, record NCT00901199. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00901199
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combined Chelation Therapy in Patients With Transfusion Dependent Thalassemia and Iron Overload
- NCT number
- NCT00901199
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Elliott Vichinsky
- Conditions
- Thalassemia, Iron Overload
- Interventions
- Combo Chelation with Deferasirox (Exjade) and Deferoxamine (DFO)
- First posted
- 2009-05-13
- Last updated
- 2021-08-12
- Results first posted
- 2021-08-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of Combined Treatment With Deferasirox and Deferoxamine Over 12 Months | 12 months | Change in liver iron concentration from baseline to 12 months with the use of combined chelation therapy. The change was calculated as the liver iron concentration at 12 months minus the value at baseline. |
| Primary | Change in Serum Creatinine During 12 Months Combined Chelation Therapy | 12 months | Comparison of average serum creatinine over 12 months of combined chelation therapy compared with baseline serum creatinine. |
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 | Efficacy of Combined Treatment With Deferasirox and Deferoxamine Over 12 Months | 12 months | Eighteen subjects completed one year of therapy. Four subjects did not complete the study for the following reasons: lost to follow-up (1), abdominal pain (1), death (1), and non-compliance (1). | mg/g | MEDIAN |
| PRIMARY | Change in Serum Creatinine During 12 Months Combined Chelation Therapy | 12 months | mg/dl | MEAN |
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 |
|---|---|---|---|---|---|
| Efficacy of Combined Treatment With Deferasirox and Deferoxamine Over 12 Months | Deferasirox (Exjade) and Desferal (DFO) | -6.2 | Full Range -23.1 to 2.7 | mg/g | |
| Change in Serum Creatinine During 12 Months Combined Chelation Therapy | Deferasirox (Exjade) and Desferal (DFO) | 0.09 | 95% Confidence Interval 0.05 to 0.12 | mg/dl |
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 | Deferasirox (Exjade) and Deferoxamine (DFO) | 22 | |
| Overall Study | COMPLETED | Deferasirox (Exjade) and Deferoxamine (DFO) | 18 | |
| Overall Study | NOT COMPLETED | Deferasirox (Exjade) and Deferoxamine (DFO) | 4 |
Source ClinicalTrials.gov
Adverse events4
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 | Transfusion reaction | Blood and lymphatic system disorders | Deferasirox (Exjade) and Deferoxamine (DFO) | 1 | 22 | 1 |
| serious | Cholelithiasis | Hepatobiliary disorders | Deferasirox (Exjade) and Deferoxamine (DFO) | 1 | 22 | 1 |
| serious | Central venous line infection | Infections and infestations | Deferasirox (Exjade) and Deferoxamine (DFO) | 1 | 22 | 1 |
| serious | Death | Cardiac disorders | Deferasirox (Exjade) and Deferoxamine (DFO) | 1 | 22 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Deferasirox (Exjade) and Deferoxamine (DFO) | 1 | 22 |
| Total, other adverse events | Deferasirox (Exjade) and Deferoxamine (DFO) | 1 | 22 |
| Total, serious adverse events | Deferasirox (Exjade) and Deferoxamine (DFO) | 2 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23151373 | 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/NCT00901199
GET https://conductscience.org/api/trials/v1/NCT00901199/registered