EXTEND (Eltrombopag Extended Dosing Study) (EXTEND)

March 5, 2017 updated by: Novartis Pharmaceuticals

EXTEND (Eltrombopag Extended Dosing Study): An Extension Study of Eltrombopag Olamine (SB-497115-GR) in Adults, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study.

An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. This study will allow adjustment of the eltrombopag dose to achieve an individualized dose and schedule for each subject. In addition, the ability to reduce the dose of concomitant ITP medications in the presence of eltrombopag, while maintaining platelet counts = 50,000/μL will be investigated.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2606
        • Novartis Investigative Site
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Novartis Investigative Site
      • Vienna, Austria, A-1090
        • Novartis Investigative Site
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H2L 4M1
        • Novartis Investigative Site
      • Jiang Su Province, China, 215006
        • Novartis Investigative Site
      • Shanghai, China, 200025
        • Novartis Investigative Site
      • Tianjin, China, 300020
        • Novartis Investigative Site
      • Brno, Czech Republic, 625 00
        • Novartis Investigative Site
      • Olomouc, Czech Republic, 775 20
        • Novartis Investigative Site
      • Praha 2, Czech Republic, 128 20
        • Novartis Investigative Site
      • Odense, Denmark, 5000
        • Novartis Investigative Site
      • Kuopio, Finland, 70210
        • Novartis Investigative Site
      • Caen cedex 9, France, 14033
        • Novartis Investigative Site
      • Créteil, France, 94010
        • Novartis Investigative Site
      • Pessac, France, 33604
        • Novartis Investigative Site
      • Berlin, Germany, 13353
        • Novartis Investigative Site
    • Bayern
      • Muenchen, Bayern, Germany, 80639
        • Novartis Investigative Site
    • Hessen
      • Giessen, Hessen, Germany, 35392
        • Novartis Investigative Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Novartis Investigative Site
      • Hannover, Niedersachsen, Germany, 30159
        • Novartis Investigative Site
    • Saarland
      • Saarbruecken, Saarland, Germany, 66113
        • Novartis Investigative Site
      • Athens, Greece, 10676
        • Novartis Investigative Site
      • Athens, Greece, 11525
        • Novartis Investigative Site
      • Thessaloniki, Greece, 57010
        • Novartis Investigative Site
      • Shatin, New Territories, Hong Kong
        • Novartis Investigative Site
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • Novartis Investigative Site
    • Lazio
      • Albano Laziale (Roma), Lazio, Italy, 00041
        • Novartis Investigative Site
    • Lombardia
      • Milano, Lombardia, Italy, 20132
        • Novartis Investigative Site
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 136-705
        • Novartis Investigative Site
      • Amersfoort, Netherlands, 3816 CP
        • Novartis Investigative Site
      • Amsterdam, Netherlands, 1105 AZ
        • Novartis Investigative Site
      • Den Haag, Netherlands, 2545 CH
        • Novartis Investigative Site
      • Nijmegen, Netherlands, 6525 GA
        • Novartis Investigative Site
      • Rotterdam, Netherlands, 3015 GE
        • Novartis Investigative Site
      • Auckland, New Zealand, 2024
        • Novartis Investigative Site
      • Christchurch, New Zealand, 8011
        • Novartis Investigative Site
      • Grafton, New Zealand, 1001
        • Novartis Investigative Site
      • Takapuna, Auckland, New Zealand, 0622
        • Novartis Investigative Site
      • Karachi, Pakistan, 75300
        • Novartis Investigative Site
      • Lahore, Pakistan, 54600
        • Novartis Investigative Site
      • Lima, Peru, LIMA 27
        • Novartis Investigative Site
      • Lima, Peru, Lima 41
        • Novartis Investigative Site
      • Bialystok, Poland, 15-276
        • Novartis Investigative Site
      • Lodz, Poland, 93-510
        • Novartis Investigative Site
      • Lublin, Poland, 20-081
        • Novartis Investigative Site
      • Slupsk, Poland, 76-200
        • Novartis Investigative Site
      • Torun, Poland, 87-100
        • Novartis Investigative Site
      • Wroclaw, Poland, 50-367
        • Novartis Investigative Site
      • Bucharest, Romania, 022328
        • Novartis Investigative Site
      • Bucharest, Romania, 050098
        • Novartis Investigative Site
      • Moscow, Russian Federation, 125167
        • Novartis Investigative Site
      • Moscow, Russian Federation, 105 229
        • Novartis Investigative Site
      • Novosibirsk, Russian Federation, 630087
        • Novartis Investigative Site
      • St Petersburg, Russian Federation, 193024
        • Novartis Investigative Site
      • Kosice, Slovakia, 041 90
        • Novartis Investigative Site
      • Presov, Slovakia, 080 01
        • Novartis Investigative Site
      • Ljubljana, Slovenia, 1000
        • Novartis Investigative Site
      • Badalona/Barcelona, Spain, 08916
        • Novartis Investigative Site
      • Barcelona, Spain, 08025
        • Novartis Investigative Site
      • Madrid, Spain, 28006
        • Novartis Investigative Site
      • Madrid, Spain, 28007
        • Novartis Investigative Site
      • Palma de Mallorca, Spain, 07014
        • Novartis Investigative Site
      • Pamplona, Spain, 31008
        • Novartis Investigative Site
      • Santiago de Compostela, Spain, 15706
        • Novartis Investigative Site
      • Göteborg, Sweden, SE-413 45
        • Novartis Investigative Site
      • Stockholm, Sweden, SE 171 76
        • Novartis Investigative Site
      • Taipei, Taiwan, 100
        • Novartis Investigative Site
      • Bangkok, Thailand, 10330
        • Novartis Investigative Site
      • Khon Kaen, Thailand, 40002
        • Novartis Investigative Site
      • Montfleury, Tunisia, 1008
        • Novartis Investigative Site
      • Sfax, Tunisia, 3029
        • Novartis Investigative Site
      • Sousse, Tunisia, 4000
        • Novartis Investigative Site
      • Tunis, Tunisia, 1008
        • Novartis Investigative Site
      • Dnipropetrovsk, Ukraine, 49102
        • Novartis Investigative Site
      • Lviv, Ukraine, 79044
        • Novartis Investigative Site
      • Liverpool, United Kingdom, L7 8XP
        • Novartis Investigative Site
      • London, United Kingdom, NW1 2PG
        • Novartis Investigative Site
      • London, United Kingdom, E1 1BB
        • Novartis Investigative Site
      • Manchester, United Kingdom, M13 9WL
        • Novartis Investigative Site
      • Reading, United Kingdom, RG1 5AN
        • Novartis Investigative Site
      • Swansea, United Kingdom, SA6 6NL
        • Novartis Investigative Site
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Novartis Investigative Site
    • Somerset
      • Taunton, Somerset, United Kingdom, TA1 5DA
        • Novartis Investigative Site
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Novartis Investigative Site
      • Mobile, Alabama, United States, 36608
        • Novartis Investigative Site
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Novartis Investigative Site
    • California
      • Duarte, California, United States, 91010
        • Novartis Investigative Site
      • Los Angeles, California, United States, 90033
        • Novartis Investigative Site
      • San Francisco, California, United States, 94143
        • Novartis Investigative Site
    • Florida
      • Miami, Florida, United States, 33136
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30341
        • Novartis Investigative Site
      • Savannah, Georgia, United States, 31405
        • Novartis Investigative Site
    • Illinois
      • Peoria, Illinois, United States, 61614
        • Novartis Investigative Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Novartis Investigative Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Novartis Investigative Site
    • Minnesota
      • Brunsville, Minnesota, United States, 55337
        • Novartis Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Novartis Investigative Site
    • New York
      • New York, New York, United States, 10021
        • Novartis Investigative Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Novartis Investigative Site
    • Oregon
      • Portland, Oregon, United States, 97227
        • Novartis Investigative Site
    • Texas
      • Lubbock, Texas, United States, 79410
        • Novartis Investigative Site
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Novartis Investigative Site
    • Washington
      • Seattle, Washington, United States, 98109
        • Novartis Investigative Site
      • Tacoma, Washington, United States, 98405
        • Novartis Investigative Site
      • Vancouver, Washington, United States, 98684
        • Novartis Investigative Site
      • Ho Chi Minh, Vietnam
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject has signed and dated a written informed consent.
  • Adults (≥18 years) diagnosed with ITP according to the American Society for Hematology/British Committee for Standards in Haematology (ASH/BCSH) guidelines [George, 1996; BCSH, 2003]. In addition, a peripheral blood smear should support the diagnosis of ITP with no evidence of other disease causative of thrombocytopenia (e.g., pseudo thrombocytopenia, myelofibrosis). The physical examination should not suggest any disease which may cause thrombocytopenia other than ITP.
  • Prior completion of treatment and follow up periods in an ITP study of eltrombopag (e.g., TRA100773 or TRA102537/RAISE or TRA108057/REPEAT).
  • Subjects previously enrolled in Study TRA100773 must have completed the prescribed follow-up ophthalmic assessment at 6 months.
  • Subjects previously enrolled in TRA102537/RAISE or other studies that may lead into EXTEND (e.g., TRA108057/REPEAT) must have completed the treatment and follow-up periods as defined in that protocol.
  • Subject experienced no eltrombopag-related toxicity or other drug intolerance on prior eltrombopag study (e.g., TRA100773 or TRA102537/RAISE or TRA108057/REPEAT) even if resolved; subjects discontinued from previous study due to toxicity will not be eligible unless they received placebo.
  • Subject has no intercurrent medical event, including thrombosis.
  • Subjects must have either initially responded (platelet count > 100,000/mL) to a previous ITP therapy or have had a bone marrow examination consistent with ITP within 3 years to rule out myelodysplastic syndromes or other causes of thrombocytopenia
  • Previous therapy for ITP with immunoglobulins (IVIg and anti-D) must have been completed at least 1 week prior to first dose of study medication and the platelet count must show a clear downward trend after the last treatment with immunoglobulins. Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide must have been completed at least 4 weeks prior to randomization, or clearly be ineffective.
  • Subjects treated with concomitant ITP medication (e.g. corticosteroids or azathioprine) must be receiving a dose that has been stable for at least 4 weeks prior to randomization. Subjects treated with cyclosporine A, mycophenolate mofetil or danazol must be receiving a dose that has been stable for at least 3 months prior to the first dose of study medication.
  • Prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) must be within 80 to 120% of the normal range with no history of hypercoagulable state.
  • A complete blood count (CBC), within the reference range (including WBC differential not indicative of a disorder other than ITP), with the following exceptions:
  • Hemoglobin: Subjects with hemoglobin levels between 10.0 g/dL and the lower limit of normal are eligible for inclusion, if anemia is clearly attributable to ITP (excessive blood loss).
  • ANC≥1500/mL (1.5 x 10^9/L) is required for inclusion (elevated WBC/ANC due to steroid treatment is acceptable).
  • The following clinical chemistries MUST NOT exceed the upper limit of normal (ULN) reference range by more than 20%: creatinine, ALT, AST, total bilirubin, and alkaline phosphatase. In addition, total albumin must not be below the lower limit of normal (LLN) by more than 10%.
  • Subject is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subjects) must either be of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal > 1 year), or of childbearing potential and use one of the following highly effective methods of contraception (i.e., Pearl Index <1.0%) from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study:
  • Complete abstinence from intercourse;
  • Intrauterine device (IUD);
  • Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide);
  • Male partner is sterile prior to entry into the study and is the only partner of the female;
  • Systemic contraceptives (combined or progesterone only).
  • Subject is able to understand and comply with protocol requirements and instructions.

Exclusion Criteria:

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

  • Any clinically relevant abnormality, other than 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 or suggests another diagnosis.
  • Concurrent malignant disease and/or history of cancer treatment with cytotoxic chemotherapy and/or radiotherapy.
  • Any prior history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), AND≥two of the following risk factors: hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, ATIII deficiency, etc), or any other family history of arterial or venous thrombosis
  • Pre-existing 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 >450 msec.
  • Female subjects who are nursing or pregnant (positive serum or urine b-human chorionic gonadotrophin (b-hCG) pregnancy test) at screening or pre-dose on Day 1.
  • History of alcohol/drug abuse.
  • Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.
  • Subject 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.
  • History of platelet agglutination abnormality that prevents reliable measurement of platelet counts.
  • All subjects with secondary immune thrombocytopenia, including those with laboratory or clinical evidence of HIV infection, antiphospholipid antibody syndrome, chronic hepatitis B infection, hepatitis C virus infection, or any evidence for active hepatitis at the time of subject screening. If a potential subject has no clinical history that would support HIV infection or hepatitis infection, no further laboratory screening is necessary; however, standard medical practice would suggest further evaluation of patients who have risk factors for these infections.
  • A subject is planning to have cataract surgery.
  • In France, a subject is neither affiliated with nor a beneficiary of a social security category.

Other Eligibility Criteria Considerations:

To assess any potential impact on subject eligibility with regard to safety, the investigator must refer to the following document(s) for detailed information regarding warnings, precautions, contraindications, adverse events, and other significant data pertaining to the investigational product(s) being used in this study: CIB, SPM.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eltrombopag
Open-label eltrombopag
Eltrombopag with starting dose of 50mg daily, max dose of 75mg daily and min dose of 25mg daily or less frequently. Modifications were given to maintain platelet count in range of 50 to 200 Gi/L.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Summary of On-Therapy Adverse Events (Safety Population)
Time Frame: Start date was the first dose of investigational product and up to the day after the last dose . Post-therapy: start date was more than 1 day after the last dose and up to 30 days after last dose of investigational product up to week 364
All safety evaluation findings considered to be adverse events are reported in the Adverse Event section.
Start date was the first dose of investigational product and up to the day after the last dose . Post-therapy: start date was more than 1 day after the last dose and up to 30 days after last dose of investigational product up to week 364

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects Achieving Maximum Platelet Counts Greater Than or Equal to 30 Gi/L or 50 Gi/L in the Absence of Rescue Medication
Time Frame: Baseline up to 2 years

Subjects who achieved maximum platelet count at least once during treatment. All platelet counts after an on-study splenectomy are not classed as responses.

Platelet counts within 7 days after a platelet transfusion are not classed as responses.

Platelet counts while taking an increased ITP medication or within 6 weeks after the end of an increased ITP medication are not classed as responses.

Baseline up to 2 years
Summary of Subjects Achieving Platelet Count Levels by Week, in the Absence of Rescue Medication
Time Frame: Baseline up to Year 7/Week 364

If a subject has more than 1 platelet count result within a week, the lowest value observed is used to determine response. All platelet counts after an on-study splenectomy are not classed as responses. Platelet counts within 7 days after a platelet transfusion are not classed as responses.

Platelet counts while taking an increased ITP medication or within 6 weeks after the end of an increased ITP medication are not classed as responses.

Baseline up to Year 7/Week 364
Number of Subjects Who Responded to Eltrombopag in a Previous Study and Who Respond to Retreatment With a Rise in Platelet Count to Either ≥ 50,000/µL or ≥30,000/µL
Time Frame: Baseline up to 2 years
Responder in TRA100773: Platelet count 50 Gi/L and 2 x baseline (BL) at last on-treatment assessment. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline (BL), 50 Gi/L, and 30 Gi/L at any time. Responder in RAISE: Platelet count 50GI/L and 2 x baseline at Week 6 assessment. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline, 50 Gi/L, and 30 Gi/L at any time. Responder in REPEAT: Platelet count 50 GI/L and 2 x baseline (BL) at Week 6 assessment in Cycle 1. Responders in EXTEND: Platelet count 50 Gi/L and 2 x baseline (BL) 50 Gi/L, and 30 Gi/L at any time.
Baseline up to 2 years
Number of Participants With Reduction and/or Sparing of Concomitant ITP Therapies, While Maintaining a Platelet Count ≥ 50,000/mL.
Time Frame: Baseline up to 2 years
Sustain reduct: Sustained reduction 1 Denominator is number of subjects taking an ITP medication at baseline. 2 Denominator is number of subjects with a sustained reduction. Note: Sustained reduction defined as reduction from baseline in dose and/or frequency which is maintained for at least 4 weeks. Excludes sustained reductions started more than 1 day after last dose.
Baseline up to 2 years
Number of Subjects Who Required Rescue Therapy During Treatment With Eltrombopag.
Time Frame: Baseline up to 2 years
Rescue treatment is defined as a composite of: new ITP medication, increased dose of a concomitant ITP medication, platelet transfusion, and splenectomy. Subjects may have received more than 1 type of rescue therapy
Baseline up to 2 years
Maximum ITP Bleeding Score at Any Time During the Study During All Stages.
Time Frame: Baseline up to 2 years
The ITP bleeding score is a tool which has been designed specifically to assess the bruising and bleeding in patients with ITP across body sites, ranging from mild to severe. The WHO Grades were dichotomized into the following categories: - Grade 0, No bleeding -Grade 1 to 4, Any bleeding -Grade 0 to 1: No clinically significant bleeding -Grade 2 to 4 Clinically significant bleeding
Baseline up to 2 years
Best Post-Baseline Change in SF-36v2 Questionnaire Score From Any Time Point Compared With Baseline
Time Frame: Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years
The SF-36v2 assessment tool was used to obtain information about subjects' general health status and health-related quality of life. Until a formal assessment of minimal clinically important differences (MCID) is performed, changes from baseline of more than 0.5 standard deviations are suggested as clinically meaningful. Scores were transformed to a 0-100 point scale, with higher scores representing more positive answers. Scores were normalized to have a mean of 50 and SD of 10 to allow for comparison with outcomes from other chronic diseases. Recall period is the past week prior to administration. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group
Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years
Best Post-Baseline Change in the Short Form of the Motivation and Energy Scale (MEI-SF) From Any Time Point Compared With Baseline
Time Frame: Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years
The MEI-SF (18 questions) was used to measure the reductions in mental energy, physical energy, and social motivation, either as symptoms of chronic ITP or as a side effect of pharmacotherapy. Minimal clinically important differences are estimated as 0.5 standard deviations or 7.5 points. All items use either a 7-level (0 to 6) or 5-level (0 to 4) response scale; items with a 5-level response scale were rescaled to 7-levels, and items were reverse-scored as necessary such that higher scores represent higher HRQoL Total score ranges from 0 to 108 points. Recall period is past week prior to administration. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group
Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years
Best Post-Baseline Change in the FACIT-Fatigue 13 Item Subscale Score From Any Time Point Compared to Baseline
Time Frame: Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years

The FACIT-Fatigue consists of 13 questions in which patients rate the frequency (0-4) of symptoms of fatigue, in terms of tiredness, weakness, and fatigue Items were reverse-scored as necessary such that higher scores represent higher HRQoL Total score ranges from 0 to 52.Using anchor-based estimates, the minimally important difference in this subscale is 3.0 points.

Recall period is past week prior to administration. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group

Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years
Best Post-Baseline Change in the FACT-TH6 at Any Time Point Compared to Baseline
Time Frame: Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years
The FACT-TH6 consists of 6 questions in which patients rate (0-4) their general degree of worry related to bleeding and bruising, and resulting activity impairment and frustration. Although the six items do not constitute a formal domain or subscale of the FACT-Th assessment tool, these items had been identified by focus groups of patients with chronic ITP as important indicators of their HRQoL. Items were reverse-scored as necessary such that higher scores represent higher HRQoL. Total scores ranged from 0 to 24. Recall period is not specified. The change in scores was measured at the transitioning period and immediately prior to withdrawal/completion over 2 years, and the mean of these measurements was recorded to calculate the change from baseline and the best post baseline change score was reported for the entire group
Baseline, beginning of each stage, change in therapy and minimum frequency of every 3 months during stages, prior to early discontinuation, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

July 10, 2006

First Submitted That Met QC Criteria

July 10, 2006

First Posted (Estimate)

July 12, 2006

Study Record Updates

Last Update Posted (Actual)

April 17, 2017

Last Update Submitted That Met QC Criteria

March 5, 2017

Last Verified

March 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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