A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study)

Study 200170: A Rollover Study to Provide Continued Treatment with Eltrombopag - Eltrombopag rollover protocol

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001371-20-IE

Enrollment

100

Registered

2013-07-11

Start date

2013-09-06

Completion date

Unknown

Last updated

2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 14.1 Level: LLT Classification code 10000886 Term: Acute myeloid leukemia System Organ Class: 100000004864 MedDRA version: 14.1 Level: PT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura System Organ Class: 10005329 - Blood and lymphatic system disorders

Interventions

Trade Name: REVOLADE Product Name: Eltrombopag Product Code: SB-497115 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ELTROMBOPAG CAS Number: 496775-61-2 Current Sponsor code: SB-497115

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects eligible for enrolment in the study must meet all of the following criteria: 1. Written informed consent has been obtained from the subject (or subject’s legally acceptable representative) prior to performance of any study-specific procedure. 2. 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. 3. Subjects with a QTc =65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: Subjects meeting any of the following criteria must not be enrolled in the study: 1. 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. 2. The subject is pregnant or a lactating female. 3. 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. 4. 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this study is to provide continuing treatment with eltrombopag for subjects who are currently participating in a GSK sponsored investigational study of eltrombopag (parent study) and to collect long term safety data.;Secondary Objective: Not applicable;Primary end point(s): The objective of this study is to provide continuing treatment with eltrombopag for subjects who are currently participating in a GSK sponsored investigational study of eltrombopag (parent study) and to collect long term safety data;Timepoint(s) of evaluation of this end point: End of study	—

Measure

Time frame

Main Objective: The objective of this study is to provide continuing treatment with eltrombopag for subjects who are currently participating in a GSK sponsored investigational study of eltrombopag (parent study) and to collect long term safety data.;Secondary Objective: Not applicable;Primary end point(s): The objective of this study is to provide continuing treatment with eltrombopag for subjects who are currently participating in a GSK sponsored investigational study of eltrombopag (parent study) and to collect long term safety data;Timepoint(s) of evaluation of this end point: End of study

—

Secondary

Measure	Time frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Argentina, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Russian Federation, Spain, Taiwan, Thailand, Tunisia, United States

Contacts

Public ContactClinical Trials Helpdesk

GlaxoSmithKline Research & Development Ltd.

GSKClinicalSupportHD@gsk.com+442089904466

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026