Immune ThrombocytopeniaNCT01386723
End of EXTEND: Discontinuation of Medication for Patients With Immune Thrombocytopenia
An observational study of Immune Thrombocytopenia, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This study proposes to observe whether a stable platelet count would be maintained without additional treatment in the long term in at least a proportion of patients who have discontinued eltrombopag taken for at least 4 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- Discontinuation of eltrombopag
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to 31 Jan 2017
- 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: ITP patients discontinuing the use of eltrombopag
Who may be able to join
- A subject is eligible for study entry if all of the following criteria apply:
- Subject or their guardian has signed and dated a written informed consent
- Male or female adults (≥ 18 years) diagnosed with ITP according to the new consensus guidelines
- No indication of a disease which may cause thrombocytopenia other than ITP.
- Having taken eltrombopag for at least 4 months prior to beginning of study.
- Subject experienced no toxicity other than transient eltrombopag-related toxicity or other drug intolerance.
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- Subjects treated with concomitant ITP medications (e.g. corticosteroids or azathioprine) must be receiving a dose that has been stable for at least four weeks prior to start of this study.
- A subject is practicing an acceptable method of contraception (documented in chart). female subjects or female partners of male subjects must either be of non-child bearing potential (hysterectomy, bilateral ovariectomy, bilateral tubal ligation or post menopausal for more than one year) OR of child bearing potential using one of the following highly effective methods of contraception.
- complete abstinence from intercourse
- Intrauterine device (IUD)
- Two forms of barrier contraception. diaphragm plus spermicide, or for males condoms plus spermicide.
- Male partner is sterile and is the only partner of the female.
- Systemic contraceptives (combined oral progesterone only)
Who cannot join
- A subject is at least temporarily ineligible for the study if any of the following criteria apply:
- Any clinically relevant abnormality, other than chronic ITP, identified on the screening examination, or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study such as:
- an active malignancy
- an arterial or venous thrombosis
- development of grade III-IV cardiovascular disease (including congestive heart failure, New York Heart Association (NYHA Grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation), or subjects with a QTc >480 msec.
- Recent history of alcohol/drug abuse.
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- Subjects recently treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for > 3 consecutive days within 2 weeks of the study start and until the end of the study.
- development of platelet agglutination abnormality that prevents reliable measurement of platelet counts.
- Rescreening is possible if the condition resulting in the failed screening has been resolved. There will be no limit on the number of screening tests and the screening will be valid for 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, 10065
About this study
Official title: End of EXTEND: Observing for Sustained Response Despite Discontinuation of Medication in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP) Treated With Eltrombopag
This study proposes to observe whether a stable platelet count would be maintained without additional treatment in the long term in at least a proportion of patients who have discontinued eltrombopag taken for at least 4 months. This requires that if patients stop treatment with eltrombopag, they are not immediately transitioned to further treatment unless it is necessary.
The objective of the study is to assess how frequently patients who have discontinued eltrombopag attain a stable, treatment-free, unmaintained adequate platelet count 4 to 8 weeks after discontinuing eltrombopag and how long such a response lasts (if it occurs).
- Conditions
- Immune Thrombocytopenia
- Being tested
- Discontinuation of eltrombopag
- Keywords
- eltrombopag, promacta, immune thrombocytopenia (ITP)
- 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.
Discontinuation of eltrombopagDrug
Also called eltrombopag, promacta
Observation of subjects as they discontinue the use of eltrombopag
| Study group | Role | What they receive |
|---|---|---|
| Discontinuation of eltrombopag | ITP subjects who have discontinued the use of eltrombopag Receives: Drug: Discontinuation of eltrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Response
To determine the frequency of a sustained response of at least 6 months in subjects with persistent or chronic ITP who have been receiving eltrombopag for a minimum of four months and are able to discontinue it within two years of initiating the tapering
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 posted1 Jul 2011 (estimated)
- Study startJun 2011
- Primary completion31 Jan 2017
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
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- James B. Bussel, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386723
- Sponsor's protocol ID
- 1003010950
- Status last verified
- Jul 2018
- First submitted
- 13 Jun 2011
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End of EXTEND: Observing for Sustained Response Despite Discontinuation of Medication in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP) Treated With Eltrombopag
- ClinicalTrials.gov ID
- NCT01386723
- Acronym / sponsor ID
- 1003010950
- Conditions
- Immune Thrombocytopenia
- Keywords
- eltrombopag, promacta, immune thrombocytopenia (ITP)
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jun 2011
- Primary completion
- 31 Jan 2017 (actual)
- First posted
- 1 Jul 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.
This study proposes to observe whether a stable platelet count would be maintained without additional treatment in the long term in at least a proportion of patients who have discontinued eltrombopag taken for at least 4 months. This requires that if patients stop treatment with eltrombopag, they are not immediately transitioned to further treatment unless it is necessary.
The objective of the study is to assess how frequently patients who have discontinued eltrombopag attain a stable, treatment-free, unmaintained adequate platelet count 4 to 8 weeks after discontinuing eltrombopag and how long such a response lasts (if it occurs).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Discontinuation of eltrombopag | – | Drug: Discontinuation of eltrombopagITP subjects who have discontinued the use of eltrombopag |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ITP patients discontinuing the use of eltrombopag
Key inclusion criteria (13 listed)
- A subject is eligible for study entry if all of the following criteria apply:
- complete abstinence from intercourse
- Intrauterine device (IUD)
- Two forms of barrier contraception. diaphragm plus spermicide, or for males condoms plus spermicide.
- Male partner is sterile and is the only partner of the female.
Key exclusion criteria (9 listed)
- A subject is at least temporarily ineligible for the study if any of the following criteria apply:
- Any clinically relevant abnormality, other than chronic ITP, identified on the screening examination, or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study such as:
- Recent history of alcohol/drug abuse.
- Subjects recently treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for > 3 consecutive days within 2 weeks of the study start and until the end of the study.
- development of platelet agglutination abnormality that prevents reliable measurement of platelet counts.
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 |
|---|---|---|
| Discontinuation of eltrombopagAlso: eltrombopag, promactaObservation of subjects as they discontinue the use of eltrombopag | Drug | Discontinuation of eltrombopag |
Primary outcome
Platelet Response
Time frame: 6 months
To determine the frequency of a sustained response of at least 6 months in subjects with persistent or chronic ITP who have been receiving eltrombopag for a minimum of four months and are able to discontinue it within two years of initiating the tapering
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
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 13 inclusion and 9 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: stopped early, as of the sponsor's last update on 17 Jul 2018. 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 was stopped early. Results are not available in the source record.
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 Response (time frame: 6 months). 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 17 Jul 2018.