Purpura, Thrombocytopaenic, IdiopathicNCT01416311

Drug Use Investigation for REVOLADE (ITP)

An observational study of Purpura, Thrombocytopaenic, Idiopathic, run by Novartis Pharmaceuticals.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To investigate safety and efficacy in the actual use of REVOLADE collected from all subjects receiving the drug until data from a specified number of subjects are accumulated to identify factors considered to influence its safety and efficacy. <Priority investigation item> Thromboembolism Read more about this study

Who is it for?: Any age
Conditions the study is for: Purpura, Thrombocytopaenic, Idiopathic
What is being tested?: Eltrombopag
How many people: 5,797 participants
Where: No sites listed yet
Study dates: 21 Dec 2010to 16 Oct 2020
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: All Japanese subjects with chronic idiopathic thrombocytopenic purpura who recieve REVOLADE

Who may be able to join

Subjects with chronic idiopathic thrombocytopenic purpura

Who cannot join

Not applicable

About this study

Official title: Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura)

<Priority investigation item> Thromboembolism

Conditions: Purpura, Thrombocytopaenic, Idiopathic
Being tested: Eltrombopag
Medical subject headings: Purpura

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EltrombopagDrug

Study groups in NCT01416311
Study group	Role	What they receive
Subjects prescribed REVOLADE		Subjects with chronic idiopathic thrombocytopenic purpura prescribed REVOLADE during study period Receives: Drug: Eltrombopag

What is being measured

The primary outcome is the main question the study is designed to answer.

The number of subjects with any adverse events treated with REVOLADE
Measured: 1 year

Secondary outcomes (1)

Appearance of thromboembolism
If thromboembolism is appeared or not in subjects who received REVOLADE will be investigated throughout the study period
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 201016 Oct 2020

First posted15 Aug 2011 (estimated)
Study start21 Dec 2010
Primary completion16 Oct 2020
Study completion16 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Purpura, Thrombocytopaenic, IdiopathicStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe 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: Prospective
Enrolment: 5,797 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01416311
Sponsor's protocol ID: 114877
Other IDs: CETB115B1401
Status last verified: Nov 2020
First submitted: 9 Jun 2011
Last updated: 20 Nov 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura)
ClinicalTrials.gov ID: NCT01416311
Acronym / sponsor ID: 114877
Conditions: Purpura, Thrombocytopaenic, Idiopathic
Study type: Observational
Recruitment status: Completed
Enrolment: 5,797 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 21 Dec 2010 (actual)
Primary completion: 16 Oct 2020 (actual)
Study completion: 16 Oct 2020 (actual)
First posted: 15 Aug 2011 (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.

<Priority investigation item> Thromboembolism

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Subjects prescribed REVOLADE	–	Drug: EltrombopagSubjects with chronic idiopathic thrombocytopenic purpura prescribed REVOLADE during study period

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: All Japanese subjects with chronic idiopathic thrombocytopenic purpura who recieve REVOLADE

Key inclusion criteria (1 listed)

Subjects with chronic idiopathic thrombocytopenic purpura

Key exclusion criteria (1 listed)

Not applicable

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
Eltrombopag	Drug	Subjects prescribed REVOLADE

Primary outcome

The number of subjects with any adverse events treated with REVOLADE
Time frame: 1 year

1 secondary outcome

Appearance of thromboembolism
Time frame: 1 year

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 20 Nov 2020.

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.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

Questions about this trial

What is this clinical trial studying?

An observational study of Purpura, Thrombocytopaenic, Idiopathic, run by Novartis Pharmaceuticals.

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 1 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 20 Nov 2020. 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 number of subjects with any adverse events treated with REVOLADE (time frame: 1 year). 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 NCT01416311.

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 20 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.