Immune ThrombocytopeniaNCT01974232
A Retrospective Chart Review of Thirty Three Children Who Have Received Clinical Treatment With Either Romiplostim or Eltrombopag From 2009-2013
An observational study of Immune Thrombocytopenia, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This is a retrospective analysis of children (≤21years old) who received clinical treatment with either Romiplostim or Eltrombopag at 2 medical centers from 2009-2013. The children included in this study were from Weill Medical College of Cornell University, New York, New York and Children's Hospital Orange County… Read more about this study
- Who is it for?
- Ages 19 months to 21 years
- Conditions the study is for
- Immune Thrombocytopenia
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2013
- 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 19 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients eligible for this study included both males and females ≤ 21 years old (actual range 19 months - 19 years) with persistent/chronic ITP lasting >6 months and were diagnosed according to the clinical practice guidelines from the American Society of Hematology.
Who may be able to join
- 1. All patients in this study had received prior treatments before the start of TPO treatment including corticosteroids, IVIG, IV anti-D, and/or Rituximab.
Who cannot join
- 1. Children who do not have ITP
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10065
About this study
This is a retrospective analysis of children (≤21years old) who received clinical treatment with either Romiplostim or Eltrombopag at 2 medical centers from 2009-2013. The children included in this study were from Weill Medical College of Cornell University, New York, New York and Children's Hospital Orange County, Orange, California
- Conditions
- Immune Thrombocytopenia
- Keywords
- Immune Thrombocytopenia (ITP), Thrombopoietin (TPO) agents, children, romiplostim and eltrombopag
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Jacobs syndrome
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 |
|---|---|---|
| Romiplostim group | Not described | |
| Eltrombopag group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet count greater than or = to 50,000
Measured: on two consecutive weeks
Secondary outcomes (1)
An increase in platelets greater than or = to 20,000 over baseline.
Measured: On two consecutive weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Orange County
- Responsible party
- Sponsor
- Investigators
- James B Bussel, M.D, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974232
- Sponsor's protocol ID
- 1310014390
- Status last verified
- Jan 2017
- First submitted
- 25 Oct 2013
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Chart Review of Thirty Three Children Who Have Received Clinical Treatment With Either Romiplostim or Eltrombopag From 2009-2013
- ClinicalTrials.gov ID
- NCT01974232
- Acronym / sponsor ID
- 1310014390
- Conditions
- Immune Thrombocytopenia
- Keywords
- Immune Thrombocytopenia (ITP), Thrombopoietin (TPO) agents, children, romiplostim and eltrombopag
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Orange County
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Nov 2013 (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 is a retrospective analysis of children (≤21years old) who received clinical treatment with either Romiplostim or Eltrombopag at 2 medical centers from 2009-2013. The children included in this study were from Weill Medical College of Cornell University, New York, New York and Children's Hospital Orange County, Orange, California
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Romiplostim group | – | – |
| Eltrombopag group | – | – |
Who may qualify
- Ages
- 19 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients eligible for this study included both males and females ≤ 21 years old (actual range 19 months - 19 years) with persistent/chronic ITP lasting >6 months and were diagnosed according to the clinical practice guidelines from the American Society of Hematology.
Key inclusion criteria (1 listed)
- 1. All patients in this study had received prior treatments before the start of TPO treatment including corticosteroids, IVIG, IV anti-D, and/or Rituximab.
Key exclusion criteria (1 listed)
- 1. Children who do not have ITP
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
Platelet count greater than or = to 50,000
Time frame: on two consecutive weeks
1 secondary outcome
An increase in platelets greater than or = to 20,000 over baseline.
Time frame: On two consecutive weeks
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 1 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Immune Thrombocytopenia
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
RecruitingPhase 3
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
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.
James B Bussel, M.D principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Thrombocytopenia, run by Weill Medical College of Cornell University at 1 site in United States.
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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Platelet count greater than or = to 50,000 (time frame: on two consecutive 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 1 Feb 2017.