Relinquished

Study Description:

This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

The purpose of this study is to investigate the efficacy, safety and tolerability of eltrombopag in children with previously treated chronic immune thrombocytopenia who are between 1 and 17 years of age. This is a 2 part study. In part 1, patients will be randomized to receive either eltrombopag or placebo for 13 weeks. All patients who complete part 1 will enter part 2. In part 2, all patients will receive 24 weeks of eltrombopag.

GSK Study ID:

115450


Has Results Document Available
ClinicalTrials.gov Identifier:

NCT01520909


Has Results Available Below
EudraCT Number:

2011-002184-17


Study Overview

Medical Conditions

Thrombocytopenia

Product

eltrombopag

Collaborators

N/A


Date

March 2012 to January 2014

Type

Interventional

Phase

3


Gender

Both

Age

1 years - 17 years

Accepts Healthy Volunteers

No


Study Documents

This study has Protocol and Result summary on ClinicalTrial.gov. Click here to learn more.

Locations

Argentina, Buenos Aires, Capital Federal 1425Completed
Czech Republic, Brno 613 00Completed
Czech Republic, Olomouc 775 20Completed
Czech Republic, Ostrava 708 52Completed
Czech Republic, Praha 5 154 00Completed
Germany, Baden-Wuerttemberg, Freiburg 79106Completed
Germany, Berlin, Berlin 13353Completed
Germany, Rheinland-Pfalz, Mainz 55131Completed
Hong Kong, Pokfulam Completed
Hong Kong, Shatin Completed
Israel, Beer-Sheva 84101Completed
Israel, Haifa 31048Completed
Israel, Petah-Tikva 49202Completed
Israel, Ramat Gan 52621Completed
Israel, Rehovot 76100Terminated
Israel, Tel-Aviv 64239Completed
Italy, Emilia-Romagna, Bologna 40138Completed
Italy, Lazio, Roma 00165Completed
Italy, Lombardia, Monza 20900Completed
Italy, Piemonte, Torino 10126Completed
Poland, Bydgoszcz Completed
Poland, Gdansk 80-952Terminated
Poland, Lodz 91-738Terminated
Poland, Lublin 20-093Terminated
Russia, Krasnodar 350007Completed
Russia, Moscow 117198Completed
Russia, Moscow 105077Completed
Russia, Saint Petersburg 198205Completed
Spain, Barcelona 08035Terminated
Spain, Madrid 28007Completed
Spain, Madrid Completed
Spain, Murcia (El Palmar) 30120Completed
Spain, Málaga 29011Terminated
Spain, Pamplona 31008Terminated
Spain, Valencia 46026Completed
Taiwan, Tainan 704Completed
Taiwan, Taoyuan 333Completed
Thailand, Bangkok 10330Completed
Thailand, Bangkok Completed
Thailand, Khon Kaen 40002Completed
Thailand, Songkla 90110Completed
United Kingdom, Birmingham B4 6NHTerminated
United Kingdom, Cardiff CF14 4XWCompleted
United Kingdom, London SW17 0QTCompleted
United Kingdom, Manchester M13 9WLCompleted
United Kingdom, Romford RM7 0AGCompleted
United Kingdom, Sheffield S10 2THCompleted
United States, California, Los Angeles 90027Completed
United States, Florida, St. Petersburg 33701Completed
United States, New York, Brooklyn 11219Completed
United States, Utah, Salt Lake City 84113Completed

Study Design

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Study Design: Parallel Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: Yes
  • Masked Caregiver: Yes
  • Masked Investigator: Yes
  • Masked Assessor: Yes
Primary Outcomes:

  • Number of participants achieving a platelet count >=50 giga cells per liter (Gi/L) for at least 6 out of 8 weeks, between Weeks 5 and 12 of Part 1
    Timeframe: From Week 5 up to Week 12 of Part 1

Secondary Outcomes:

  • Percentage of Responders
    Timeframe: From Week 1 up to Week 12 of Part 1

  • Number of participants achieving a platelet count >=50 Gi/L at any time during the first 12 weeks of Part 1
    Timeframe: From Baseline up to Week 12 of Part 1

  • Number of participants achieving a platelet count >=50 Gi/L at any time during the first 6 weeks of Part 1
    Timeframe: From Baseline up to Week 6 of Part 1

  • Weighted mean platelet count
    Timeframe: Baseline and Week 12 of Part 1

  • Maximum duration for which a participant continuously maintained a platelet count of >=50 Gi/L during the first 12 weeks of Part 1
    Timeframe: From Baseline up to Week 12 of Part 1

  • Number of participants who required a protocol-defined rescue treatment during Part 1
    Timeframe: From Baseline up to Week 12 of Part 1

  • Number of participants with any bleeding and significant bleeding as assessed using the World Health Organization (WHO) Bleeding Scale during Part 1
    Timeframe: From Baseline through Follow-up of Part 1

  • Number of participants who achieved a platelet count >=50 Gi/L at any time during Part 2
    Timeframe: From Baseline up to Week 24 of Part 2

  • Number of weeks in which participants achieved a platelet count >=50 Gi/L, between Weeks 4 and 24 of Part 2
    Timeframe: From Week 4 up to Week 24 of Part 2

  • Maximum duration for which a participant continuously maintained a platelet count of >=50 Gi/L during Part 2
    Timeframe: From Baseline up to Week 24 of Part 2

  • Number of participants who reduced or discontinued Baseline concomitant ITP medications during Part 2 without requiring subsequent rescue therapy
    Timeframe: From Baseline up to Week 24 of Part 2

  • Number of participants who required a protocol-defined rescue treatment during Part 2
    Timeframe: From Baseline up to Week 24 of Part 2

  • Number of participants with any bleeding and significant bleeding as assessed using the WHO Bleeding Scale during Part 2
    Timeframe: From Baseline of Part 2 through Follow-up

  • Number of participants with any adverse event (AE) or serious adverse event (SAE) during Part 1
    Timeframe: From Day 1 of Treatment up to Week 13 of Part 1+ 1 day

  • Number of participants with any adverse event (AE) or serious adverse event (SAE) during Part 2
    Timeframe: From Day 1 of Part 2 up to Week 24 of Part 2 + 1 day

  • Number of participants with the indicated maximum toxicity grade for the indicated clinical chemistry parameters at any time post-Baseline during Part 1
    Timeframe: From Baseline up to Week 13 of Part 1

  • Number of participants with the indicated maximum toxicity grade for the indicated clinical chemistry parameters at any time post-Baseline during Part 2
    Timeframe: From Baseline (BL) of Part 2 through Follow-up

  • Number of participants with the indicated maximum toxicity grade for the indicated hematology parameters at any time post-Baseline during Part 1
    Timeframe: From Baseline up to Week 13 of Part 1

  • Number of participants with the indicated maximum toxicity grade for the indicated hematology parameters at any time post-Baseline during Part 2
    Timeframe: From Baseline up to Week 24 of Part 2 and Follow-up Weeks 1 to 4 (up to Study Week 41)

  • Number of participants with vital sign data falling outside the reference ranges (RR) at the indicated visit during Part 1
    Timeframe: From Screening (SCR) up to Week 13 of Part 1

  • Number of participants with vital sign data falling outside the reference ranges (RR) at the indicated visit during Part 2
    Timeframe: From Week 1 up to Week 24 of Part 2 and Follow-up Week 1 to Week 4 (up to Week 41)

  • Number of participants with a change in visual acuity since Baseline at Week 12 of Part 1
    Timeframe: Baseline and Week 12 of Part 1

  • Number of participants with a change in visual acuity since Baseline at Week 24 of Part 2
    Timeframe: Baseline and Week 24 of Part 2

  • Number of participants with a change in visual acuity since Baseline at Follow-Up Week 24
    Timeframe: Baseline and Follow-Up Week 24 (Study Week 61)

  • Number of participants with worsening visual acuity due to cataracts at Week 12 of Part 1
    Timeframe: Baseline and Week 12 of Part 1

  • Number of participants with worsening visual acuity due to cataracts at Week 24 of Part 2
    Timeframe: Baseline and Week 24 of Part 2

  • Number of participants with worsening visual acuity due to cataracts at Follow-Up Week 24
    Timeframe: Baseline and Follow-Up Week 24 (Week 61)

  • Pharmacokinetic (PK) assessments for eltrombopag for AUC (0-t)
    Timeframe: Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)

  • Pharmacokinetic (PK) assessments for eltrombopag for Cmax
    Timeframe: Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)

  • Pharmacokinetic (PK) assessments for eltrombopag for apparent oral clearance (CL/F) and apparent intercompartmental clearance (Q/F)
    Timeframe: Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)

  • PK assessments for eltrombopag for apparent central volume (Vc/F) and apparent peripheral volume (Vp/F)
    Timeframe: Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)

  • Population PK model point estimate for eltrombopag for absorption rate-constant (Ka)
    Timeframe: Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)

Arms:
  • 3

Interventions:

  • Drug: Eltrombopag
  • Drug: Placebo

Keyword:

  • immune thrombocytopenic purpura, pediatrics, chronic ITP, idiopathic thrombocytopenic purpura, eltrombopag, Chronic Immune Thrombocytopenia, platelet disorder, thrombocytopenia
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 92