We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

End of EXTEND: Discontinuation of Medication for Patients With Immune Thrombocytopenia

This study is currently recruiting participants.
Verified January 2017 by James B. Bussel, Weill Medical College of Cornell University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01386723
First Posted: July 1, 2011
Last Update Posted: February 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by (Responsible Party):
James B. Bussel, Weill Medical College of Cornell University
  Purpose

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).


Condition Intervention
Immune Thrombocytopenia Drug: Discontinuation of eltrombopag

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by James B. Bussel, Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA
Blood specimens

Estimated Enrollment: 20
Study Start Date: June 2011
Estimated Study Completion Date: June 30, 2019
Estimated Primary Completion Date: March 30, 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Discontinuation of eltrombopag
ITP subjects who have discontinued the use of eltrombopag
Drug: Discontinuation of eltrombopag
Observation of subjects as they discontinue the use of eltrombopag
Other Name: eltrombopag, promacta

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ITP patients discontinuing the use of eltrombopag
Criteria

Inclusion Criteria:

  • 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.
    • 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)

Exclusion Criteria:

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.
  • 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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386723


Contacts
Contact: James B Bussel, MD 212-746-3474 jbussel@med.cornell.edu
Contact: Arelys M Rocha, BS, BA, CCRC 212-746-3423 arr7008@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College/New York Presbyterian Hospital Recruiting
NY, New York, United States, 10065
Contact: James B Bussel, MD    212-746-3474    jbussel@med.cornell.edu   
Contact: Arelys M Rocha, BS, BA, CCRC    212-746-3423    arr7008@med.cornell.edu   
Principal Investigator: James B Bussel, MD         
Sub-Investigator: Arelys M Rocha, BS, BA, CCRC         
Sub-Investigator: Catherine McGuinn, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Novartis
Investigators
Principal Investigator: James B. Bussel, M.D. Weill Medical College of Cornell University
  More Information

Responsible Party: James B. Bussel, Professor, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01386723     History of Changes
Other Study ID Numbers: 1003010950
First Submitted: June 13, 2011
First Posted: July 1, 2011
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by James B. Bussel, Weill Medical College of Cornell University:
eltrombopag
promacta
immune thrombocytopenia (ITP)

Additional relevant MeSH terms:
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms