Trial · NCT00351468

EXTEND (Eltrombopag Extended Dosing Study)

NCT00351468, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2017-04-17

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. EXTEND (Eltrombopag Extended Dosing Study). Trials, record NCT00351468. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00351468

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: EXTEND (Eltrombopag Extended Dosing Study)
NCT number: NCT00351468
Status: Completed
Phases: Phase 3
Enrollment: 302 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Purpura, Thrombocytopaenic, Idiopathic
Interventions: eltrombopag olamine (SB-497115-GR)
First posted: 2006-07-12
Last updated: 2017-04-17
Results first posted: 2017-04-17

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Summary of On-Therapy Adverse Events (Safety Population)	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.
Secondary	Subjects Achieving Maximum Platelet Counts Greater Than or Equal to 30 Gi/L or 50 Gi/L in the Absence of Rescue Medication	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.
Secondary	Summary of Subjects Achieving Platelet Count Levels by Week, in the Absence of Rescue Medication	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.
Secondary	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	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.
Secondary	Number of Participants With Reduction and/or Sparing of Concomitant ITP Therapies, While Maintaining a Platelet Count ≥ 50,000/mL.	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.
Secondary	Number of Subjects Who Required Rescue Therapy During Treatment With Eltrombopag.	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
Secondary	Maximum ITP Bleeding Score at Any Time During the Study During All Stages.	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
Secondary	Best Post-Baseline Change in SF-36v2 Questionnaire Score From Any Time Point Compared With Baseline	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
Secondary	Best Post-Baseline Change in the Short Form of the Motivation and Energy Scale (MEI-SF) From Any Time Point Compared With Baseline	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
Secondary	Best Post-Baseline Change in the FACIT-Fatigue 13 Item Subscale Score From Any Time Point Compared to Baseline	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

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Summary of On-Therapy Adverse Events (Safety Population)	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		Participants	NUMBER
SECONDARY	Subjects Achieving Maximum Platelet Counts Greater Than or Equal to 30 Gi/L or 50 Gi/L in the Absence of Rescue Medication	Baseline up to 2 years	ITT population	Participants	NUMBER
SECONDARY	Summary of Subjects Achieving Platelet Count Levels by Week, in the Absence of Rescue Medication	Baseline up to Year 7/Week 364	ITT population	Participants	NUMBER
SECONDARY	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	Baseline up to 2 years	ITT	Participants	NUMBER
SECONDARY	Number of Participants With Reduction and/or Sparing of Concomitant ITP Therapies, While Maintaining a Platelet Count ≥ 50,000/mL.	Baseline up to 2 years		Participants	NUMBER
SECONDARY	Number of Subjects Who Required Rescue Therapy During Treatment With Eltrombopag.	Baseline up to 2 years		Participants	NUMBER
SECONDARY	Maximum ITP Bleeding Score at Any Time During the Study During All Stages.	Baseline up to 2 years		Participants	NUMBER
SECONDARY	Best Post-Baseline Change in SF-36v2 Questionnaire Score From Any Time Point Compared With Baseline	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		Points on a scale	MEAN
SECONDARY	Best Post-Baseline Change in the Short Form of the Motivation and Energy Scale (MEI-SF) From Any Time Point Compared With Baseline	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		Points on a scale	MEAN
SECONDARY	Best Post-Baseline Change in the FACIT-Fatigue 13 Item Subscale Score From Any Time Point Compared to Baseline	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	ITT	Points on a scale	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group114

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Overall Summary of On-Therapy Adverse Events (Safety Population)	Eltrombopag	Any adverse event	277	Participants
Overall Summary of On-Therapy Adverse Events (Safety Population)	Eltrombopag	Any serious adverse event	96	Participants
Overall Summary of On-Therapy Adverse Events (Safety Population)	Eltrombopag	Adverse events related to study medication	133	Participants
Overall Summary of On-Therapy Adverse Events (Safety Population)	Eltrombopag	Adverse events leading to withdrawal	41	Participants
Overall Summary of On-Therapy Adverse Events (Safety Population)	Eltrombopag	Serious adverse events leading withdrawal	28	Participants
Subjects Achieving Maximum Platelet Counts Greater Than or Equal to 30 Gi/L or 50 Gi/L in the Absence of Rescue Medication	Eltrombopag	Baseline Platelet counts >= 30 Gi/L,	91	Participants
Subjects Achieving Maximum Platelet Counts Greater Than or Equal to 30 Gi/L or 50 Gi/L in the Absence of Rescue Medication	Eltrombopag	Baseline Platelet counts >= 50 Gi/L,	42	Participants
Subjects Achieving Maximum Platelet Counts Greater Than or Equal to 30 Gi/L or 50 Gi/L in the Absence of Rescue Medication	Eltrombopag	Maximum Platelet Count >= 30 Gi/L	276	Participants
Subjects Achieving Maximum Platelet Counts Greater Than or Equal to 30 Gi/L or 50 Gi/L in the Absence of Rescue Medication	Eltrombopag	Maximum Platelet Count >= 50 Gi/L	259	Participants
Summary of Subjects Achieving Platelet Count Levels by Week, in the Absence of Rescue Medication	Eltrombopag	Baseline Platelet counts >= 30 Gi/L, n=302	91	Participants

1 to 10 of 114Source ClinicalTrials.gov

See all 114 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Eltrombopag	302
Overall Study	Subjects From TRA100773A	Eltrombopag	51
Overall Study	Subjects From TRA100773B	Eltrombopag	61
Overall Study	Subjects From TRA102537 Raise	Eltrombopag	146
Overall Study	Subjects From TRA108057 Repeat	Eltrombopag	43
Overall Study	Unknown - Not From Previous Trial	Eltrombopag	1
Overall Study	COMPLETED	Eltrombopag	135
Overall Study	NOT COMPLETED	Eltrombopag	167

Source ClinicalTrials.gov

Adverse events360

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Eltrombopag, Treatment + 1 Day	26	302
other	Anaemia	Blood and lymphatic system disorders	Eltrombopag, >1 to 30 Days Post-Therapy	1	302
other	Abdominal pain	Gastrointestinal disorders	Eltrombopag, Treatment + 1 Day	18	302
other	Abdominal pain	Gastrointestinal disorders	Eltrombopag, >1 to 30 Days Post-Therapy	0	302
other	Abdominal pain upper	Gastrointestinal disorders	Eltrombopag, Treatment + 1 Day	18	302
other	Abdominal pain upper	Gastrointestinal disorders	Eltrombopag, >1 to 30 Days Post-Therapy	1	302
other	Constipation	Gastrointestinal disorders	Eltrombopag, Treatment + 1 Day	26	302
other	Constipation	Gastrointestinal disorders	Eltrombopag, >1 to 30 Days Post-Therapy	2	302
other	Diarrhoea	Gastrointestinal disorders	Eltrombopag, Treatment + 1 Day	46	302
other	Diarrhoea	Gastrointestinal disorders	Eltrombopag, >1 to 30 Days Post-Therapy	3	302

1 to 10 of 360Source ClinicalTrials.gov

See all 360 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Eltrombopag, Treatment + 1 Day
Total, all-cause mortality	Eltrombopag, >1 to 30 Days Post-Therapy
Total, other adverse events	Eltrombopag, Treatment + 1 Day	253	302
Total, other adverse events	Eltrombopag, >1 to 30 Days Post-Therapy	28	302
Total, serious adverse events	Eltrombopag, Treatment + 1 Day	96	302
Total, serious adverse events	Eltrombopag, >1 to 30 Days Post-Therapy	10	302

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21533818	DERIVED	PubMed
22117897	DERIVED	PubMed
23169778	DERIVED	PubMed
23492914	DERIVED	PubMed
29042367	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Eltrombopag, Treatment + 1 Day vs Eltrombopag, >1 to 30 Days Post-Therapy: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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