Idiopathic Thrombocytopenic PurpuraNCT00861224
Effects of Long-term Dosing of AMG 531 on Bone Marrow Morphology
An observational study of Idiopathic Thrombocytopenic Purpura, run by Amgen.
Trial summary
This study was conducted in conjunction with the 2 phase 3 studies of AMG 531 (20030105 and 20030212) and an open-label extension study (20030213) and compared pretreatment and posttreatment bone marrow samples for the purpose of studying morphologic changes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Thrombocytopenic Purpura
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to May 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Splenectomized or nonsplenectomized subjects with a primary diagnosis of ITP from either of the phase 3 studies (20030105 or 20030212) or the open-label extension study 20030213; pretreatment bone marrow biopsy within 1 year of enrollment into the phase 3 study; separate written informed consent for the follow-up bone marrow.
Who may be able to join
- Subjects must be enrolled in AMG 531 protocol 20030105 or 20030212
- Subject must have had a bone marrow biopsy within one year of enrollment (with available tissue block to send to a central pathology laboratory for interpretation) or must consent to a pre-treatment bone marrow biopsy and aspirate
- Written informed consent
Who cannot join
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
About this study
Official title: The Effects of Long-term Dosing of AMG 531 on Bone Marrow Morphology in Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
This study was conducted in conjunction with the 2 phase 3 studies of AMG 531 (20030105 and 20030212) and an open-label extension study (20030213) and compared pretreatment and posttreatment bone marrow samples for the purpose of studying morphologic changes.
Read the detailed description
This study is to be performed in conjunction with the phase 3 treatment studies (20030105 and 20030212) and with the open label extension study (20030213).
Subjects who are screening for participation in the phase 3 studies will be asked to consider participation in this bone marrow study. At least 10 subjects from each of the two phase 3 studies (20030105 and 20030212) will enroll in this study. This will ensure enrollment of subjects who are both non-splenectomized and splenectomized.
All subjects who participate must have had a bone marrow biopsy within one year prior to enrollment, and must release the tissue block to Amgen for interpretation by a central pathology laboratory. Subjects that do not have a historical bone marrow within one year (with available tissue block) must have a baseline bone marrow biopsy and aspirate performed prior to dosing with AMG 531.
Subjects will be assigned to a follow-up bone marrow biopsy and aspirate after either 9 months or 6 months of treatment. The subjects will be assigned to follow-up time in descending order, with the first 5 subjects from each study assigned to 9 month follow-up, and the last 5 subjects from each study assigned to 6 month follow-up. Some subjects will have their follow-up bone marrow biopsy and aspirate while on the open label extension study (20030213).
To eliminate the possibility of performing a bone marrow biopsy and aspirate on a placebo subject, all subjects who were assigned to a 6 month follow-up will be unblinded at the end of the phase 3 study treatment period (week 26). If the subject was on AMG 531, they must have their follow-up bone marrow biopsy and aspirate within one week (week 27). If the subject was on placebo, they will have their follow-up bone marrow performed after 3 months of treatment in the open label study.
The subjects that were assigned to a 9 month follow-up will have their platelet counts monitored as required by the phase 3 protocol. Any subject who has a platelet count > 50 x 109/L at week 26 of the phase 3 study, will be required to schedule a bone marrow biopsy and aspirate for week 27. If their platelet count is still > 50 x 109/L at week 27, they will have their bone marrow biopsy and aspirate at that time. If their platelet count drops to ≤ 50 x 109/L prior to week 27, they will have their follow-up bone marrow biopsy and aspirate performed after completing 3 months of treatment on the open label study (20030213).
Subjects who discontinue AMG 531 treatment will have the follow-up bone marrow biopsy and aspirate at the time of discontinuation, regardless of the pre-assigned date of the follow-up.
If a subject requires a bone marrow biopsy and aspirate as part of a safety assessment, this assessment will be counted as the follow-up bone marrow biopsy regardless of the timing of the assessment. Any additional clinically warranted bone marrow biopsies will also be sent to the central pathology lab for review.
All bone marrow biopsy reports will be provided by the central lab at the end of this study, but will not be available for clinical management at the time that the sample is collected.
All bone marrow biopsies will be evaluated by the central pathology lab.
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Being tested
- No Intervention for Observational Study
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention for Observational StudyOther
No intervention was used on this protocol, as this was an observational study.
| Study group | Role | What they receive |
|---|---|---|
| Observed Subjects | Subjects that submitted bone marrow biopsy and aspirates. Receives: Other: No Intervention for Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes from baseline in bone marrow morphology by subject
Measured: Entire duration of the study
Secondary outcomes (3)
The changes from baseline in bone marrow morphology by dose range
Measured: Entire duration of the study
The changes from baseline in bone marrow morphology by length of treatment with AMG 531
Measured: Entire duration of the study
The changes from baseline bone marrow morphology for splenectomized and non-splenectomized subjects
Measured: Entire duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startAug 2005
- Primary completionOct 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861224
- Sponsor's protocol ID
- 20050123
- Status last verified
- Jul 2010
- First submitted
- 12 Mar 2009
- Last updated
- 16 Jul 2010
- Results posted
- No
Publications
Kuter DJ, Mufti GJ, Bain BJ, Hasserjian RP, Davis W, Rutstein M. Evaluation of bone marrow reticulin formation in chronic immune thrombocytopenia patients treated with romiplostim. Blood. 2009 Oct 29;114(18):3748-56. doi: 10.1182/blood-2009-05-224766. Epub 2009 Aug 11.
PubMed 19671919
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Long-term Dosing of AMG 531 on Bone Marrow Morphology in Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
- ClinicalTrials.gov ID
- NCT00861224
- Acronym / sponsor ID
- 20050123
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted in conjunction with the 2 phase 3 studies of AMG 531 (20030105 and 20030212) and an open-label extension study (20030213) and compared pretreatment and posttreatment bone marrow samples for the purpose of studying morphologic changes.
Detailed description
This study is to be performed in conjunction with the phase 3 treatment studies (20030105 and 20030212) and with the open label extension study (20030213).
Subjects who are screening for participation in the phase 3 studies will be asked to consider participation in this bone marrow study. At least 10 subjects from each of the two phase 3 studies (20030105 and 20030212) will enroll in this study. This will ensure enrollment of subjects who are both non-splenectomized and splenectomized.
All subjects who participate must have had a bone marrow biopsy within one year prior to enrollment, and must release the tissue block to Amgen for interpretation by a central pathology laboratory. Subjects that do not have a historical bone marrow within one year (with available tissue block) must have a baseline bone marrow biopsy and aspirate performed prior to dosing with AMG 531.
Subjects will be assigned to a follow-up bone marrow biopsy and aspirate after either 9 months or 6 months of treatment. The subjects will be assigned to follow-up time in descending order, with the first 5 subjects from each study assigned to 9 month follow-up, and the last 5 subjects from each study assigned to 6 month follow-up. Some subjects will have their follow-up bone marrow biopsy and aspirate while on the open label extension study (20030213).
To eliminate the possibility of performing a bone marrow biopsy and aspirate on a placebo subject, all subjects who were assigned to a 6 month follow-up will be unblinded at the end of the phase 3 study treatment period (week 26). If the subject was on AMG 531, they must have their follow-up bone marrow biopsy and aspirate within one week (week 27). If the subject was on placebo, they will have their follow-up bone marrow performed after 3 months of treatment in the open label study.
The subjects that were assigned to a 9 month follow-up will have their platelet counts monitored as required by the phase 3 protocol. Any subject who has a platelet count > 50 x 109/L at week 26 of the phase 3 study, will be required to schedule a bone marrow biopsy and aspirate for week 27. If their platelet count is still > 50 x 109/L at week 27, they will have their bone marrow biopsy and aspirate at that time. If their platelet count drops to ≤ 50 x 109/L prior to week 27, they will have their follow-up bone marrow biopsy and aspirate performed after completing 3 months of treatment on the open label study (20030213).
Subjects who discontinue AMG 531 treatment will have the follow-up bone marrow biopsy and aspirate at the time of discontinuation, regardless of the pre-assigned date of the follow-up.
If a subject requires a bone marrow biopsy and aspirate as part of a safety assessment, this assessment will be counted as the follow-up bone marrow biopsy regardless of the timing of the assessment. Any additional clinically warranted bone marrow biopsies will also be sent to the central pathology lab for review.
All bone marrow biopsy reports will be provided by the central lab at the end of this study, but will not be available for clinical management at the time that the sample is collected.
All bone marrow biopsies will be evaluated by the central pathology lab.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observed Subjects | – | Other: No Intervention for Observational StudySubjects that submitted bone marrow biopsy and aspirates. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Splenectomized or nonsplenectomized subjects with a primary diagnosis of ITP from either of the phase 3 studies (20030105 or 20030212) or the open-label extension study 20030213; pretreatment bone marrow biopsy within 1 year of enrollment into the phase 3 study; separate written informed consent for the follow-up bone marrow.
Key inclusion criteria (3 listed)
- Subjects must be enrolled in AMG 531 protocol 20030105 or 20030212
- Subject must have had a bone marrow biopsy within one year of enrollment (with available tissue block to send to a central pathology laboratory for interpretation) or must consent to a pre-treatment bone marrow biopsy and aspirate
- Written informed consent
Key exclusion criteria (1 listed)
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention for Observational StudyNo intervention was used on this protocol, as this was an observational study. | Other | Observed Subjects |
Primary outcome
The changes from baseline in bone marrow morphology by subject
Time frame: Entire duration of the study
3 secondary outcomes
The changes from baseline in bone marrow morphology by dose range
Time frame: Entire duration of the study
The changes from baseline in bone marrow morphology by length of treatment with AMG 531
Time frame: Entire duration of the study
The changes from baseline bone marrow morphology for splenectomized and non-splenectomized subjects
Time frame: Entire duration of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2010.
- Results publication: PubMed 19671919Kuter DJ, Mufti GJ, Bain BJ, Hasserjian RP, Davis W, Rutstein M. Evaluation of bone marrow reticulin formation in chronic immune thrombocytopenia patients treated with romiplostim. Blood. 2009 Oct 29;114(18):3748-56. doi: 10.1182/blood-2009-05-224766. Epub 2009 Aug 11.
- FDA-approved Drug LabelingLink provided by the sponsor.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Thrombocytopenic Purpura, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes from baseline in bone marrow morphology by subject (time frame: Entire duration of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00861224, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2010.