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A Rollover Study to Provide Continued Treatment With Eltrombopag

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.
 
ClinicalTrials.gov Identifier: NCT01957176
Recruitment Status : Recruiting
First Posted : October 8, 2013
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will provide continued access to treatment with eltrombopag for subjects who are currently participating in a GlaxoSmithKline (GSK) sponsored investigational study of eltrombopag (parent study) and to collect long term safety data.

Condition or disease Intervention/treatment Phase
Thrombocytopaenia Drug: ELT Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study 200170: A Rollover Study to Provide Continued Treatment With Eltrombopag
Actual Study Start Date : October 15, 2013
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024


Arm Intervention/treatment
Experimental: Cohort A
Cohort A consists of subjects who had completed their treatment with eltrombopag (ELT) during their participation in a parent study for Myelodysplastic syndrome (MDS)/ Acute myeloid leukemia (AML). All subjects in this cohort will receive ELT at the dose that they were receiving at the time of the transition visit, except in the case where the subject required a dose modification. The range of doses of ELT that will be used in this cohort are from 50 to 300 mg once daily (OD) for subjects of non- East Asian heritage. The dose ranges for subjects of East Asian heritage (i.e. Japanese, Chinese, Taiwanese, Thai and Korean) will be 25 to 150 mg. Dose adjustments (if required) will be done depending on each subject's platelet counts.
Drug: ELT
Subjects will be dosed with ELT tablets or powder for oral suspension (PfOS) based on the dosage form used in the parent study. ELT tablets will be white, round film coated tablets containing ELT olamine equivalent to 12.5 mg, 25 mg, 50 mg, 75 mg and 100 mg of ELT. ELT PfOS is a reddish-brown to yellow powder contained inside an elongated sachet. Each sachet will contain ELT olamine equivalent to 20 mg of ELT per gram of powder.

Experimental: Cohort B
Cohort B consists of adult subjects who have completed study treatment with ELT during their participation in a parent study for Idiopathic thrombocytopenic purpura (ITP). All subjects in this cohort will receive ELT at the dose that they were receiving at the time of the transition visit, except in the case where the subject required a dose modification. The range of doses of ELT that will be used in this cohort are from 12.5 to 75 mg. Dose adjustments (if required) will be done depending on each subject's platelet counts.
Drug: ELT
Subjects will be dosed with ELT tablets or powder for oral suspension (PfOS) based on the dosage form used in the parent study. ELT tablets will be white, round film coated tablets containing ELT olamine equivalent to 12.5 mg, 25 mg, 50 mg, 75 mg and 100 mg of ELT. ELT PfOS is a reddish-brown to yellow powder contained inside an elongated sachet. Each sachet will contain ELT olamine equivalent to 20 mg of ELT per gram of powder.

Experimental: Cohort C
Cohort C consists of pediatric subjects who have completed study treatment with ELT during their participation in a parent study for Idiopathic thrombocytopenic purpura (ITP). All subjects in this cohort will receive ELT at the dose that they were receiving at the time of the transition visit, except in the case where the subject required a dose modification. The range of doses of ELT that will be used in this cohort are from 12.5 to 75 mg. Dose adjustments (if required) will be done depending on each subject's platelet counts.
Drug: ELT
Subjects will be dosed with ELT tablets or powder for oral suspension (PfOS) based on the dosage form used in the parent study. ELT tablets will be white, round film coated tablets containing ELT olamine equivalent to 12.5 mg, 25 mg, 50 mg, 75 mg and 100 mg of ELT. ELT PfOS is a reddish-brown to yellow powder contained inside an elongated sachet. Each sachet will contain ELT olamine equivalent to 20 mg of ELT per gram of powder.




Primary Outcome Measures :
  1. Safety as assessed by physical examinations, laboratory assessments and monitoring of adverse events or serious adverse events. [ Time Frame: From the time of the transition visit until 30 days after the last study treatment ]
    AEs assessment include: Frequency and severity of AE, AE relationship to IP, AEs leading to permanent discontinuation of study drug, frequency and severity of SAE Laboratory parameters include: hematology and clinical chemistry



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.


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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent has been obtained from the subject (or subject's legally acceptable representative) prior to performance of any study-specific procedure.
  • The subject is participating in a GSK sponsored investigational study of eltrombopag (parent study) within the past 28 days and is receiving clinical benefit without unacceptable toxicity as determined by the investigator.
  • Subjects with a QTc <450 millisecond (msec) or <480 msec for subjects with bundle branch block. The QTc is the QT interval corrected for heart rate according to either Bazett's formula (QTcB), Fridericia's formula (QTcF) or another method, machine or manual overread. For subject eligibility and withdrawal QTcF will be used. For purposes of data analysis, QTcF will be used. The QTc should be based on single or averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period.
  • Women must be either of non-child bearing potential or women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study.
  • Women of childbearing potential must have a negative serum pregnancy test within 14 days of the first dose of study treatment and agree to use effective contraception, during the study and for 4 weeks following the last dose of study treatment.
  • Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from time of first dose until 16 weeks after the last dose of study treatment.
  • In France, a subject will be eligible for inclusion in this study only if either affiliated to, or a beneficiary of, a social security category.

Exclusion Criteria:

  • Permanent discontinuation of eltrombopag in the parent study based upon the study treatment discontinuation or study withdrawal criteria from the parent study. Subjects who permanently discontinued treatment because they completed all study related treatments remain eligible.
  • The subject is pregnant or a lactating female.
  • Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance with the study procedures, in the opinion of the investigator or GSK Medical Monitor.
  • French subjects: The French subject has participated in any study using an investigational drug during the previous 30 days, with the exception of eltrombopag, in the parent study.

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): NCT01957176


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Argentina
Novartis Investigative Site Recruiting
La Plata, Buenos Aires, Argentina, B1900AXI
Belgium
Novartis Investigative Site Completed
Leuven, Belgium, 3000
Brazil
Novartis Investigative Site Withdrawn
Goiania - GO, Goiás, Brazil, 74605-020
Novartis Investigative Site Withdrawn
Curitiba, Paraná, Brazil, 81520-060
Novartis Investigative Site Withdrawn
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Novartis Investigative Site Withdrawn
Barretos, São Paulo, Brazil, 14784-400
Novartis Investigative Site Withdrawn
Sao Paulo, São Paulo, Brazil, 01236030
Novartis Investigative Site Withdrawn
Rio de Janeiro, Brazil, 20211-030
China
Novartis Investigative Site Recruiting
Shanghai, China, 200025
France
Novartis Investigative Site Completed
Paris Cedex 12, France, 75571
Greece
Novartis Investigative Site Completed
Athens, Greece, 11527
Novartis Investigative Site Completed
Heraklion, Crete, Greece, 71201
Novartis Investigative Site Withdrawn
Ioannina, Greece, 45 500
Novartis Investigative Site Withdrawn
Thessaloniki, Greece, 57010
Hong Kong
Novartis Investigative Site Completed
Shatin, Hong Kong
Hungary
Novartis Investigative Site Recruiting
Debrecen, Hungary, 4012
Ireland
Novartis Investigative Site Completed
Tullamore, Ireland
Israel
Novartis Investigative Site Recruiting
Tel Aviv, Israel, 64239
Korea, Republic of
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 02841
Mexico
Novartis Investigative Site Withdrawn
Monterrey, Nuevo León, Mexico, 64460
Novartis Investigative Site Withdrawn
Chihuahua, Mexico, 31203
Novartis Investigative Site Withdrawn
Mexico City, Mexico, CP 14080
Novartis Investigative Site Withdrawn
Oaxaca, Mexico, 68000
Netherlands
Novartis Investigative Site Completed
Amsterdam, Netherlands, 1081 HV
Peru
Novartis Investigative Site Recruiting
San Isidro, Lima, Peru, Lima 27
Novartis Investigative Site Withdrawn
Lima, Peru, Lima 31
Poland
Novartis Investigative Site Completed
Chorzow, Poland, 41-500
Romania
Novartis Investigative Site Recruiting
Bucharest, Romania, 022328
Russian Federation
Novartis Investigative Site Withdrawn
Nizhniy Novgorod, Russian Federation, 603126
Novartis Investigative Site Withdrawn
Petrozavodsk, Russian Federation, 185019
Novartis Investigative Site Withdrawn
St Petersburg, Russian Federation, 193024
Novartis Investigative Site Withdrawn
St'Petersburg, Russian Federation, 197341
Novartis Investigative Site Withdrawn
St. Petersburg, Russian Federation, 197 089
Spain
Novartis Investigative Site Withdrawn
Barcelona, Spain, 08036
Novartis Investigative Site Withdrawn
Madrid, Spain, 28034
Novartis Investigative Site Withdrawn
Malaga, Spain, 29010
Novartis Investigative Site Withdrawn
Pozuelo De Alarcon/Madrid, Spain, 28223
Novartis Investigative Site Withdrawn
Salamanca, Spain, 37007
Novartis Investigative Site Withdrawn
Santander, Spain, 39008
Thailand
Novartis Investigative Site Withdrawn
Bangkok, Thailand, 10400
Novartis Investigative Site Withdrawn
Bangkok, Thailand, 10700
Novartis Investigative Site Withdrawn
Khon Kaen, Thailand, 40002
Tunisia
Novartis Investigative Site Recruiting
Montfleury, Tunisia, 1008
Novartis Investigative Site Recruiting
Sousse, Tunisia, 4000
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01957176    
Other Study ID Numbers: 200170
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
myelodysplastic syndromes
thrombocytopenia
acute myeloid leukemia
, idiopathic thrombocytopenic purpura
Eltrombopag
pediatrics
Additional relevant MeSH terms:
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Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases