Trial · NCT01352585
Exploratory Multi-centre Trial In Patients With ET Treated With XAGRID®
NCT01352585, Completed, Shire; results first posted 2014-07-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Exploratory Multi-centre Trial In Patients With ET Treated With XAGRID®. Trials, record NCT01352585. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01352585
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exploratory Multi-centre Trial In Patients With ET Treated With XAGRID®
- NCT number
- NCT01352585
- Status
- Completed
- Enrollment
- 47 participants, actual
- Lead sponsor
- Shire
- Conditions
- Essential Thrombocythemia (ET)
- Interventions
- Anagrelide hydrochloride
- First posted
- 2011-05-12
- Last updated
- 2021-07-30
- Results first posted
- 2014-07-29
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Platelet Count ≤600x10^9/L After 12 Months | 1 year | A platelet count of ≤600x10\^9/L after 12 months is considered at least a partial response. |
| Secondary | Number of Patients With Platelet Count ≤400x10^9/L After 12 Months | 1 year | A platelet count of ≤400x10\^9/L after 12 months is considered a complete response. |
| Secondary | Platelet Count | 1 year | |
| Secondary | Red Blood Cell (RBC) Count | 1 year | |
| Secondary | White Blood Cell (WBC) Count | 1 year | |
| Secondary | Differential WBC Count - Neutrophils, Lymphocytes, Monocytes, and Basophils. | 1 year | |
| Secondary | Differential WBC Count - Eosinophils | 1 year | |
| Secondary | Hemoglobin Concentration | 1 year | |
| Secondary | Hematocrit Level | 1 year | The proportion of the volume of red blood cells to the total volume of blood. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Platelet Count ≤600x10^9/L After 12 Months | 1 year | The Full Analysis Set (FAS) in each JAK2 status group who had a viable platelet sample during the 12-month follow-up window. For this Outcome Measure 35 patients in the FAS had a viable laboratory sample. | participants | NUMBER |
| SECONDARY | Number of Patients With Platelet Count ≤400x10^9/L After 12 Months | 1 year | The Full Analysis Set (FAS) in each JAK2 status group who had a viable platelet sample during the 12-month follow-up window. For this Outcome Measure 35 patients in the FAS had a viable laboratory sample. | participants | NUMBER |
| SECONDARY | Platelet Count | 1 year | The Full Analysis Set (FAS) in each JAK2 status group who had a viable platelet sample during the 12-month follow-up window. For this Outcome Measure 28 patients in the FAS had a viable laboratory sample. | Platelets (x10^9/L) | MEAN |
| SECONDARY | Red Blood Cell (RBC) Count | 1 year | The Safety Analysis Set (SAS) consisted of all subjects enrolled in the study who took at least 1 dose of anagrelide hydrochloride. 27 patients in the SAS met this requirement and had a viable laboratory sample. | RBC Count (x10^12/L) | MEAN |
| SECONDARY | White Blood Cell (WBC) Count | 1 year | The Full Analysis Set (FAS) in each JAK2 status group who had a viable platelet sample during the 12-month follow-up window. For this Outcome Measure 28 patients in the FAS had a viable laboratory sample. | WBC Count (x10^9/L) | MEAN |
| SECONDARY | Differential WBC Count - Neutrophils, Lymphocytes, Monocytes, and Basophils. | 1 year | The Full Analysis Set (FAS) in each JAK2 status group who had a viable platelet sample during the 12-month follow-up window. For this Outcome Measure 28 patients in the FAS had a viable laboratory sample. | percent | MEAN |
| SECONDARY | Differential WBC Count - Eosinophils | 1 year | The Full Analysis Set (FAS) in each JAK2 status group who had a viable platelet sample during the 12-month follow-up window. For this Outcome Measure 27 patients in the FAS had a viable laboratory sample. | percent | MEAN |
| SECONDARY | Hemoglobin Concentration | 1 year | The Safety Analysis Set (SAS) consisted of all subjects enrolled in the study who took at least 1 dose of anagrelide hydrochloride. 28 patients in the SAS had a viable laboratory sample. | g/L | MEAN |
| SECONDARY | Hematocrit Level | 1 year | The Safety Analysis Set (SAS) consisted of all subjects enrolled in the study who took at least 1 dose of anagrelide hydrochloride. 27 patients in the SAS had a viable laboratory sample. | Hematocrit (fraction of 1) | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Platelet Count ≤600x10^9/L After 12 Months | JAK2 Positive Participants | 12 | participants | ||
| Number of Patients With Platelet Count ≤600x10^9/L After 12 Months | JAK2 Negative Participants | 14 | participants | ||
| Number of Patients With Platelet Count ≤400x10^9/L After 12 Months | JAK2 Positive Participants | 7 | participants | ||
| Number of Patients With Platelet Count ≤400x10^9/L After 12 Months | JAK2 Negative Participants | 8 | participants | ||
| Platelet Count | JAK2 Positive Participants | 458.9 | Standard Deviation 163.25 | Platelets (x10^9/L) | |
| Platelet Count | JAK2 Negative Participants | 503.0 | Standard Deviation 254.04 | Platelets (x10^9/L) | |
| Red Blood Cell (RBC) Count | JAK2 Positive Participants | 4.85 | Standard Deviation 0.430 | RBC Count (x10^12/L) | |
| Red Blood Cell (RBC) Count | JAK2 Negative Participants | 4.24 | Standard Deviation 0.797 | RBC Count (x10^12/L) | |
| White Blood Cell (WBC) Count | JAK2 Positive Participants | 7.75 | Standard Deviation 1.317 | WBC Count (x10^9/L) | |
| White Blood Cell (WBC) Count | JAK2 Negative Participants | 8.77 | Standard Deviation 3.770 | WBC Count (x10^9/L) |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | JAK2 Positive Participants | 23 | |
| Overall Study | STARTED | JAK2 Negative Participants | 24 | |
| Overall Study | COMPLETED | JAK2 Positive Participants | 15 | |
| Overall Study | COMPLETED | JAK2 Negative Participants | 21 | |
| Overall Study | NOT COMPLETED | JAK2 Positive Participants | 8 | |
| Overall Study | NOT COMPLETED | JAK2 Negative Participants | 3 |
Source ClinicalTrials.gov
Adverse events20
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 | anemia | Blood and lymphatic system disorders | JAK2 Positive Participants | 1 | 23 | 1 |
| other | anemia | Blood and lymphatic system disorders | JAK2 Negative Participants | 2 | 24 | 3 |
| other | Palpitations | Cardiac disorders | JAK2 Positive Participants | 1 | 23 | 1 |
| other | Palpitations | Cardiac disorders | JAK2 Negative Participants | 1 | 24 | 1 |
| other | Tachycardia | Cardiac disorders | JAK2 Positive Participants | 1 | 23 | 1 |
| other | Tachycardia | Cardiac disorders | JAK2 Negative Participants | 1 | 24 | 1 |
| other | Scotoma | Eye disorders | JAK2 Positive Participants | 0 | 23 | |
| other | Scotoma | Eye disorders | JAK2 Negative Participants | 1 | 24 | 1 |
| other | Diarrhea | Gastrointestinal disorders | JAK2 Positive Participants | 0 | 23 | |
| other | Diarrhea | Gastrointestinal disorders | JAK2 Negative Participants | 1 | 24 | 1 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | JAK2 Positive Participants | ||
| Total, all-cause mortality | JAK2 Negative Participants | ||
| Total, other adverse events | JAK2 Positive Participants | 6 | 23 |
| Total, other adverse events | JAK2 Negative Participants | 9 | 24 |
| Total, serious adverse events | JAK2 Positive Participants | 0 | 23 |
| Total, serious adverse events | JAK2 Negative Participants | 0 | 24 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26028965 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| JAK2 Positive Participants vs JAK2 Negative Participants: Number of Patients With Platelet Count ≤600x10^9/L After 12 Months | Trial comparisons |
| JAK2 Positive Participants vs JAK2 Negative Participants: Number of Patients With Platelet Count ≤400x10^9/L After 12 Months | Trial comparisons |
| JAK2 Positive Participants vs JAK2 Negative Participants: serious adverse events | Trial comparisons |
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/NCT01352585
GET https://conductscience.org/api/trials/v1/NCT01352585/results?page=2