Immune Thrombocytopenic PurpuraNCT02085993
Study of Patients With ITP Estimating the Proportion Administering Romiplostim Correctly After Receiving Home Administration Training
An observational study of Immune Thrombocytopenic Purpura, run by Amgen at 22 sites in 8 countries.
Trial summary
Cross-sectional study, observation made by healthcare professionals of subjects or caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after training with the home administration training pack. Further observations can also be recorded in the study if made within 16 weeks of enrolment. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Immune Thrombocytopenic Purpura
- How many people
- 41 participants
- Where
- 22 sitesin 8 countries
- Study dates
- Jul 2014to Nov 2015
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ITP patients being treated with romiplostim will be approached for possible study participation. At each participating site, patients that meet the following criteria will be enrolled as a study subject. Adult ITP patients, treated per EU Summary of product characteristics (SmPC), or caregiver new (or at least a 3 month gap) to administering romiplostim, that has received HAT pack training and is available at a standard-of-care medical visit 4 weeks (range 2 to 8 weeks) after HAT pack training, the patient provides informed consent.
Who may be able to join
- (1) adult ITP patient, treated per EU Summary of product characteristics (SmPC), or caregiver new (or at least a 3 month gap) to administering romiplostim,
- (2) has received HAT pack training,
- (3) available at standard-of-care medical visit 4 weeks (range 2 to 8 weeks) after HAT pack training,
- (4) patient provides informed consent.
Who cannot join
- -No exclusion criteria for this observational study
Trial locations and contacts
22 sites in 8 countries.
22 sites in 8 countries
France5 sites
Research Site
Créteil, 94010
Research Site
Limoges, 87042
Research Site
Montpellier, 34395
Research Site
Paris, 75571
Research Site
Pessac, 33604
Spain4 sites
Research Site
Ávila, Castille and León, 05004
Research Site
Madrid, Madrid, 28031
Research Site
Madrid, Madrid, 28041
Research Site
Majadahonda, Madrid, 28222
Greece3 sites
Research Site
Athens, 11527
Research Site
Kalamata, 24100
Research Site
Thessaloniki, 54636
Netherlands2 sites
Research Site
The Hague, 2545 CH
Research Site
Veldhoven, 5504 DB
United Kingdom2 sites
Research Site
Leicester, LE1 5WW
Research Site
London, E1 1BB
About this study
Official title: A Cross-sectional Study of Patients With Immune Thrombocytopenic Purpura and Caregivers to Estimate the Proportion Who Administer Romiplostim Correctly After Receipt of Home Administration Training Materials
Cross-sectional study, observation made by healthcare professionals of subjects or caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after training with the home administration training pack. Further observations can also be recorded in the study if made within 16 weeks of enrolment. Data will be collected from the subjects' dose diary at their first standard of care visit to ensure there were no problems with administration while not at the clinic.
Read the detailed description
This cross-sectional study involves direct observation by a healthcare professional of a series of subjects and caregivers in the act of administering romiplostim at their first standard-of-care visit occurring 4 weeks after training with the HAT pack. Further observations, if they occur, will also be recorded in the study if made within 16 weeks of enrolment. (Additional observations are voluntary and are not required for study participation; they occur only if the healthcare professional requests them.) Additionally, data will be collected from the subjects' dose diary at the first standard of care visit to ensure there were no problems with administration while not at the clinic.
- Conditions
- Immune Thrombocytopenic Purpura
- Keywords
- romiplostim,, Nplate,, immune thrombocytopenic purpura
- 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.
| Study group | Role | What they receive |
|---|---|---|
| single arm | single arm study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful self administration of romiplostim
to estimate the proportion of subjects and caregivers who administer romiplostim correctly after being trained with the HAT pack.
Measured: First Standard of Care visit post Home Administration Training (range 2-8 weeks)
Secondary outcomes (4)
successful reconstitution of romiplostim
A yes/no indicator of whether the subject or caregiver reconstitutes romiplostim correctly.
Measured: First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment)
Accuracy in administering the prescribed dose of romiplostim
The difference between the prescribed and administered dose of romiplostim, expressed as a %.
Measured: First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment)
Injects romiplostim
A yes/no indicator of whether the subject or caregiver injects romiplostim successfully.
Measured: First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment)
Administers romiplostim
A yes/no indicator of whether the subject or caregiver administers romiplostim correctly.
Measured: Follow up visits (up to 16 weeks post enrolment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085993
- Sponsor's protocol ID
- 20120269
- Status last verified
- Dec 2015
- First submitted
- 11 Mar 2014
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study of Patients With Immune Thrombocytopenic Purpura and Caregivers to Estimate the Proportion Who Administer Romiplostim Correctly After Receipt of Home Administration Training Materials
- ClinicalTrials.gov ID
- NCT02085993
- Acronym / sponsor ID
- 20120269
- Conditions
- Immune Thrombocytopenic Purpura
- Keywords
- romiplostim,, Nplate,, immune thrombocytopenic purpura
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 13 Mar 2014 (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.
Cross-sectional study, observation made by healthcare professionals of subjects or caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after training with the home administration training pack. Further observations can also be recorded in the study if made within 16 weeks of enrolment. Data will be collected from the subjects' dose diary at their first standard of care visit to ensure there were no problems with administration while not at the clinic.
Detailed description
This cross-sectional study involves direct observation by a healthcare professional of a series of subjects and caregivers in the act of administering romiplostim at their first standard-of-care visit occurring 4 weeks after training with the HAT pack. Further observations, if they occur, will also be recorded in the study if made within 16 weeks of enrolment. (Additional observations are voluntary and are not required for study participation; they occur only if the healthcare professional requests them.) Additionally, data will be collected from the subjects' dose diary at the first standard of care visit to ensure there were no problems with administration while not at the clinic.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | – | –single arm study |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ITP patients being treated with romiplostim will be approached for possible study participation. At each participating site, patients that meet the following criteria will be enrolled as a study subject. Adult ITP patients, treated per EU Summary of product characteristics (SmPC), or caregiver new (or at least a 3 month gap) to administering romiplostim, that has received HAT pack training and is available at a standard-of-care medical visit 4 weeks (range 2 to 8 weeks) after HAT pack training, the patient provides informed consent.
Key inclusion criteria (4 listed)
- (1) adult ITP patient, treated per EU Summary of product characteristics (SmPC), or caregiver new (or at least a 3 month gap) to administering romiplostim,
- (2) has received HAT pack training,
- (3) available at standard-of-care medical visit 4 weeks (range 2 to 8 weeks) after HAT pack training,
- (4) patient provides informed consent.
Key exclusion criteria (1 listed)
- -No exclusion criteria for this observational study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Successful self administration of romiplostim
Time frame: First Standard of Care visit post Home Administration Training (range 2-8 weeks)
to estimate the proportion of subjects and caregivers who administer romiplostim correctly after being trained with the HAT pack.
4 secondary outcomes
successful reconstitution of romiplostim
Time frame: First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment)
Accuracy in administering the prescribed dose of romiplostim
Time frame: First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment)
Injects romiplostim
Time frame: First standard of care visit post Home Administration Training (range 2-8 weeks). Follow up visits (up to 16 weeks post enrolment)
Administers romiplostim
Time frame: Follow up visits (up to 16 weeks post enrolment)
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 22 Dec 2015.
- 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
22 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Thrombocytopenic Purpura, run by Amgen at 22 sites in 8 countries.
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 4 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 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France, Spain, Greece, Austria, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Successful self administration of romiplostim (time frame: First Standard of Care visit post Home Administration Training (range 2-8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2015.