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

NCT01386723 | Terminated DMC FDA Drug

• 1 other identifier: 1003010950
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

eltrombopag; promacta; immune thrombocytopenia (ITP)

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Study Arms (1)

Discontinuation of eltrombopag

ITP subjects who have discontinued the use of eltrombopag

Drug: Discontinuation of eltrombopag

Interventions

Discontinuation of eltrombopag DRUG

Observation of subjects as they discontinue the use of eltrombopag

Also known as: eltrombopag, promacta

Discontinuation of eltrombopag

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ITP patients discontinuing the use of eltrombopag

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Novartis: collaborator

Study Sites (1)

Weill Cornell Medical College/New York Presbyterian Hospital

New York, New York, 10065, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood specimens

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• James B. Bussel, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: July 1, 2011
• Study Start: June 1, 2011
• Primary Completion: January 31, 2017
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

US (1)