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

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ClinicalTrials.gov Identifier: NCT01386723
Recruitment Status : Terminated
First Posted : July 1, 2011
Last Update Posted : July 17, 2018
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Weill Medical College of Cornell University

June 13, 2011
July 1, 2011
July 17, 2018
June 2011
January 31, 2017   (Final data collection date for primary outcome measure)
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
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Complete list of historical versions of study NCT01386723 on ClinicalTrials.gov Archive Site
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End of EXTEND: Discontinuation of Medication for Patients With Immune Thrombocytopenia
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).

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Blood specimens
Non-Probability Sample
ITP patients discontinuing the use of eltrombopag
Immune Thrombocytopenia
Drug: Discontinuation of eltrombopag
Observation of subjects as they discontinue the use of eltrombopag
Other Name: eltrombopag, promacta
Discontinuation of eltrombopag
ITP subjects who have discontinued the use of eltrombopag
Intervention: Drug: Discontinuation of eltrombopag
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
35
20
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January 31, 2017   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01386723
1003010950
Yes
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
Plan to Share IPD: Undecided
Weill Medical College of Cornell University
Weill Medical College of Cornell University
Novartis
Principal Investigator: James B. Bussel, M.D. Weill Medical College of Cornell University
Weill Medical College of Cornell University
July 2018