Trial · NCT00907478
Study on Bone Marrow Morphology in Adults Receiving Romiplostim for Treatment of Thrombocytopenia Associated With Immune Thrombocytopenia Purpura (ITP)
NCT00907478, Phase 4, Completed, Amgen; results first posted 2015-01-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study on Bone Marrow Morphology in Adults Receiving Romiplostim for Treatment of Thrombocytopenia Associated With Immune Thrombocytopenia Purpura (ITP). Trials, record NCT00907478. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00907478
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study on Bone Marrow Morphology in Adults Receiving Romiplostim for Treatment of Thrombocytopenia Associated With Immune Thrombocytopenia Purpura (ITP)
- NCT number
- NCT00907478
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 169 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Thrombocytopenia, Idiopathic Thrombocytopenic Purpura
- Interventions
- romiplostim
- First posted
- 2009-05-22
- Last updated
- 2022-09-21
- Results first posted
- 2015-01-01
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Collagen Fibrosis | At Years 1, 2 or 3 after initial exposure of romiplostim | The percentage of participants who developed collagen fibrosis as evidenced by trichrome staining. Bone marrow biopsy samples were assessed using the modified Bauermeister grading scale by a central laboratory. |
| Secondary | Number of Participants With Collagen Fibrosis 12 Weeks After Romiplostim Discontinuation in Participants Who Developed Collagen Fibrosis at Years 1, 2, or 3 | 12 weeks after romiplostim discontinuation | The number of participants with collagen fibrosis as evidenced by trichrome staining 12 weeks after romiplostim discontinuation in participants who developed collagen fibrosis at Years 1, 2, or 3 after initial exposure of romiplostim, assessed by the central laboratory using the modified Bauermeister grading scale. |
| Secondary | Percentage of Participants Who Developed an Increased Modified Bauermeister Grade | At Year 1, Year 2, or Year 3 post romiplostim exposure | Increased modified Bauermeister grade refers to an increase by ≥ 2 severity grades or an increase to grade 4 (ie, grade 0 to 2-4, grade 1 to 3-4, grade 2 to 4, or grade 3 to 4 over baseline). The modified Bauermeister scale provides a means of assessing the development of increased reticulin and collagen in bone marrow according to the following: Grade 0: No reticulin fibers demonstrable; Grade 1: Occasional fine individual fibers and foci of a fine fiber network; Grade 2: Fine fiber network throughout most of the section; no coarse fibers; Grade 3: Diffuse fiber network with scattered thick coarse fibers but no mature collagen (negative to trichrome staining); Grade 4: Diffuse, often course fiber network with areas of collagenization (positive trichrome staining). |
| Secondary | Percentage of Participants With Clinically Relevant Changes in Total Cardiac Output Corrected (QTc) Intervals | Baseline, Week 3 and Week 12 | A clinically relevant change in QTc (Fridericia) interval is defined as an absolute QTc interval \>500 ms or a QTc Interval increase from Baseline \>60 ms post romiplostim exposure. 12-lead electrocardiograms (ECG) were performed in triplicate at Baseline, Week 3 and Week 12; the average of of the 3 values at each assessment was used. |
| Secondary | Number of Participants With Improvement of Reticulin to a Grade of ≤ 2 for Participants Who Developed Grade 3 Reticulin | 12 weeks after romiplostim discontinuation | The number of participants who had any improvement of reticulin to a grade of ≤ 2 for participants who developed grade 3 reticulin after initial exposure to romiplostim as measured by the modified Bauermeister grading scale. The modified Bauermeister scale provides a means of assessing the development of increased reticulin and collagen in bone marrow according to the following: Grade 0: No reticulin fibers demonstrable; Grade 1: Occasional fine individual fibers and foci of a fine fiber network; Grade 2: Fine fiber network throughout most of the section; no coarse fibers; Grade 3: Diffuse fiber network with scattered thick coarse fibers but no mature collagen (negative to trichrome staining); Grade 4: Diffuse, often course fiber network with areas of collagenization (positive trichrome staining). |
| Secondary | Percentage of Participants With CTCAE Grade ≥ 2 Shift in Anemia or Neutropenia | From the first dose of study drug until 4 weeks after treatment discontinuation or 12 weeks after treatment discontinuation for patients who developed collagen fibrosis or a change to grade 3 reticulin; the overall median treatment duration was 154 weeks. | Anemia was identified by laboratory values with hemoglobin \< the lower limit of normal (LLN) or the Medical Dictionary for Regulatory Activities (MedDRA) terms prespecified by the sponsor. Neutropenia was identified by laboratory values with absolute neutrophil count \<1.8x10\^9/L or the MedDRA terms pre-specified by the sponsor. Severity was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, based on the following: Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE. |
| Secondary | Number of Participants With Adverse Events (AEs) | From the first dose of study drug until 4 weeks after treatment discontinuation or 12 weeks after treatment discontinuation for patients who developed collagen fibrosis or a change to grade 3 reticulin; the overall median treatment duration was 154 weeks. | An AE was defined as any untoward medical occurrence in a participant that did not necessarily have a causal relationship with this treatment, or any such occurrence or worsening of a pre-existing medical condition from the first dose of investigational product through the last study visit. A serious adverse event is defined as an AE that is fatal or life threatening, requires or prolongs hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or other significant medical hazard. The relationship of each AE to the study drug was assessed by the investigator. The severity of each AE was graded using using CTCAE 3.0; For any AEs not listed in CTCAE, the Amgen Standard Severity Scoring System was used: 1: Mild- Aware of sign or symptom, but easily tolerated; 2 Moderate- Discomfort enough to cause interference with usual activity; 3: Severe- Incapacitating with inability to work or do usual activity; 4: Life-threatening; 5: Fatal. |
| Secondary | Number of Participants Who Developed Antibodies or Neutralizing Antibodies to Romiplostim or to Endogenous Thrombopoietin | Every 24 weeks and at the end of study visit (4 weeks or 12 weeks after study drug discontinuation). | Two validated assays were used to test for antibodies to romiplostim, the thrombopoietin-mimetic peptide component of romiplostim (TMP) and to endogenous thrombopoietin (TPO). The first was an immunoassay to confirm the presence of antibodies. The second was a cell-based bioassay to detect neutralizing or inhibitory effects in vitro. If a sample was positive in both assays, a participant was defined as positive for neutralizing antibodies. Persistent antibodies were those positive at the last timepoint tested and transient are defined as positive post-dose but negative at the last time point tested. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Collagen Fibrosis | At Years 1, 2 or 3 after initial exposure of romiplostim | Participants who had evaluable trichrome stain results | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Collagen Fibrosis 12 Weeks After Romiplostim Discontinuation in Participants Who Developed Collagen Fibrosis at Years 1, 2, or 3 | 12 weeks after romiplostim discontinuation | Participants with collagen fibrosis at Year 1, 2 or 3 and with available trichome staining results 12 weeks after study drug discontinuation. One participant with collagen fibrosis refused the follow-up bone marrow biopsy. | participants | NUMBER |
| SECONDARY | Percentage of Participants Who Developed an Increased Modified Bauermeister Grade | At Year 1, Year 2, or Year 3 post romiplostim exposure | Participants who had evaluable reticulin silver stain results | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinically Relevant Changes in Total Cardiac Output Corrected (QTc) Intervals | Baseline, Week 3 and Week 12 | All participants who received at least one dose of romiplostim. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Improvement of Reticulin to a Grade of ≤ 2 for Participants Who Developed Grade 3 Reticulin | 12 weeks after romiplostim discontinuation | Participants with Grade 3 reticulin at Year 1, 2 or 3 and who had a follow-up bone marrow biopsy 12 weeks after romiplostim discontinuation. Two participants with grade 3 reticulin did not have a bone marrow biopsy performed 12 weeks after romiploastim discontinuation. | participants | NUMBER |
| SECONDARY | Percentage of Participants With CTCAE Grade ≥ 2 Shift in Anemia or Neutropenia | From the first dose of study drug until 4 weeks after treatment discontinuation or 12 weeks after treatment discontinuation for patients who developed collagen fibrosis or a change to grade 3 reticulin; the overall median treatment duration was 154 weeks. | All participants who received at least one dose of romiplostim | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs) | From the first dose of study drug until 4 weeks after treatment discontinuation or 12 weeks after treatment discontinuation for patients who developed collagen fibrosis or a change to grade 3 reticulin; the overall median treatment duration was 154 weeks. | All participants who received at least one dose of romiplostim | participants | NUMBER |
| SECONDARY | Number of Participants Who Developed Antibodies or Neutralizing Antibodies to Romiplostim or to Endogenous Thrombopoietin | Every 24 weeks and at the end of study visit (4 weeks or 12 weeks after study drug discontinuation). | All participants who received at least one dose of romiplostim. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Collagen Fibrosis | Cohort 1 | 0.0 | 95% Confidence Interval 0.0 to 10.0 | percentage of participants | |
| Percentage of Participants With Collagen Fibrosis | Cohort 2 | 0.0 | 95% Confidence Interval 0.0 to 9.0 | percentage of participants | |
| Percentage of Participants With Collagen Fibrosis | Cohort 3 | 3.4 | 95% Confidence Interval 0.4 to 11.9 | percentage of participants | |
| Number of Participants With Collagen Fibrosis 12 Weeks After Romiplostim Discontinuation in Participants Who Developed Collagen Fibrosis at Years 1, 2, or 3 | Cohort 3 | 0 | participants | ||
| Percentage of Participants Who Developed an Increased Modified Bauermeister Grade | Cohort 1 | 0.0 | 95% Confidence Interval 0.0 to 10.3 | percentage of participants | |
| Percentage of Participants Who Developed an Increased Modified Bauermeister Grade | Cohort 2 | 5.1 | 95% Confidence Interval 0.6 to 17.3 | percentage of participants | |
| Percentage of Participants Who Developed an Increased Modified Bauermeister Grade | Cohort 3 | 12.1 | 95% Confidence Interval 5.0 to 23.3 | percentage of participants | |
| Percentage of Participants With Clinically Relevant Changes in Total Cardiac Output Corrected (QTc) Intervals | Cohort 1 | 0.0 | 95% Confidence Interval 0.0 to 7.1 | percentage of participants | |
| Percentage of Participants With Clinically Relevant Changes in Total Cardiac Output Corrected (QTc) Intervals | Cohort 2 | 0.0 | 95% Confidence Interval 0.0 to 7.1 | percentage of participants | |
| Percentage of Participants With Clinically Relevant Changes in Total Cardiac Output Corrected (QTc) Intervals | Cohort 3 | 0.0 | 95% Confidence Interval 0.0 to 5.2 | percentage of participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 50 | |
| Overall Study | STARTED | Cohort 2 | 50 | |
| Overall Study | STARTED | Cohort 3 | 69 | |
| Overall Study | COMPLETED | Cohort 1 | 23 | |
| Overall Study | COMPLETED | Cohort 2 | 33 | |
| Overall Study | COMPLETED | Cohort 3 | 47 | |
| Overall Study | NOT COMPLETED | Cohort 1 | 27 | |
| Overall Study | NOT COMPLETED | Cohort 2 | 17 | |
| Overall Study | NOT COMPLETED | Cohort 3 | 22 |
Source ClinicalTrials.gov
Adverse events652
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 | Anaemia | Blood and lymphatic system disorders | Cohort 1 | 2 | 50 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 | 2 | 50 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3 | 4 | 69 | |
| other | Anaemia | Blood and lymphatic system disorders | Overall | 8 | 169 | |
| other | Idiopathic Thrombocytopenic Purpura | Blood and lymphatic system disorders | Cohort 1 | 8 | 50 | |
| other | Idiopathic Thrombocytopenic Purpura | Blood and lymphatic system disorders | Cohort 2 | 6 | 50 | |
| other | Idiopathic Thrombocytopenic Purpura | Blood and lymphatic system disorders | Cohort 3 | 8 | 69 | |
| other | Idiopathic Thrombocytopenic Purpura | Blood and lymphatic system disorders | Overall | 22 | 169 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Cohort 1 | 2 | 50 | |
| other | Iron Deficiency Anaemia | Blood and lymphatic system disorders | Cohort 2 | 1 | 50 |
1 to 10 of 652Source ClinicalTrials.gov
See all 652 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 | ||
| Total, all-cause mortality | Cohort 2 | ||
| Total, all-cause mortality | Cohort 3 | ||
| Total, all-cause mortality | Overall | ||
| Total, other adverse events | Cohort 1 | 45 | 50 |
| Total, other adverse events | Cohort 2 | 43 | 50 |
| Total, other adverse events | Cohort 3 | 66 | 69 |
| Total, other adverse events | Overall | 154 | 169 |
| Total, serious adverse events | Cohort 1 | 16 | 50 |
| Total, serious adverse events | Cohort 2 | 12 | 50 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
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
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