ThrombocytopaeniaNCT01236014
Indirect Comparison Between Eltrombopag & Romiplostim
An observational study of Thrombocytopaenia, run by GlaxoSmithKline.
Trial summary
An indirect comparison to compare the efficacy of eltrombopag versus romiplostim Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopaenia
- What is being tested?
- Eltrombopag and Romiplostim
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Oct 2009
- 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: Identified through a systematic review: TRA102537, Kuter 2008
Who may be able to join
- Adults with ITP
- Pre-specified treatment
- Prospective clinical studies with at least 10 patients
Who cannot join
- Adults with ITP for other reasons
About this study
Official title: Indirect Comparison of Efficacy of Treatments for Idiopathic Immune Thrombocytopenic Purpura - Review of Platelet Responses and Bleeding Events
An indirect comparison to compare the efficacy of eltrombopag versus romiplostim
Read the detailed description
An indirect analysis was conducted to evaluate the relative efficacy of eltrombopag and romiplostim using placebo as a common comparator
- Conditions
- Thrombocytopaenia
- Being tested
- Eltrombopag, Romiplostim, Placebo
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EltrombopagDrug
Eltrombopag \& standard of care
RomiplostimDrug
Romiplostim \& standard of care
PlaceboDrug
Placebo \& standard of care
| Study group | Role | What they receive |
|---|---|---|
| Eltrombopag & standard of care | Not described Receives: Drug: Eltrombopag | |
| Romiplostim & standard of care | Not described Receives: Drug: Romiplostim | |
| Standard of care | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Durable response: platelet count of >=50 and <400 Gi/L
Measured: 6 months
Overall response: either a durable response or a transient platelet response
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startAug 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopaeniaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236014
- Sponsor's protocol ID
- 114014
- Status last verified
- Jun 2017
- First submitted
- 4 Nov 2010
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect Comparison of Efficacy of Treatments for Idiopathic Immune Thrombocytopenic Purpura - Review of Platelet Responses and Bleeding Events
- ClinicalTrials.gov ID
- NCT01236014
- Acronym / sponsor ID
- 114014
- Conditions
- Thrombocytopaenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 8 Nov 2010 (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.
An indirect comparison to compare the efficacy of eltrombopag versus romiplostim
Detailed description
An indirect analysis was conducted to evaluate the relative efficacy of eltrombopag and romiplostim using placebo as a common comparator
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eltrombopag & standard of care | – | Drug: Eltrombopag |
| Romiplostim & standard of care | – | Drug: Romiplostim |
| Standard of care | – | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Identified through a systematic review: TRA102537, Kuter 2008
Key inclusion criteria (3 listed)
- Adults with ITP
- Pre-specified treatment
- Prospective clinical studies with at least 10 patients
Key exclusion criteria (1 listed)
- Adults with ITP for other reasons
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 |
|---|---|---|
| EltrombopagEltrombopag \& standard of care | Drug | Eltrombopag & standard of care |
| RomiplostimRomiplostim \& standard of care | Drug | Romiplostim & standard of care |
| PlaceboPlacebo \& standard of care | Drug | Standard of care |
Primary outcome
Durable response: platelet count of >=50 and <400 Gi/L
Time frame: 6 months
Overall response: either a durable response or a transient platelet response
Time frame: 6 months
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 7 Jun 2017.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopaenia, run by GlaxoSmithKline.
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 7 Jun 2017. 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?
Durable response: platelet count of >=50 and <400 Gi/L (time frame: 6 months). The study lists 2 primary outcomes in all. 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 7 Jun 2017.