Back to resultsA Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP (TAPER)
Primary Purpose
Immune Thrombocytopenic Purpura (ITP)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
eltrombopag
Sponsored by
About this trial
This is an interventional treatment trial for Immune Thrombocytopenic Purpura (ITP) focused on measuring Thrombocytopenic, Immune, Platelets, Bleeding, ITP, eltrombopag, ETB115, induce sustained response off treatment, refractory or relapsed, first-line steroids
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent must be obtained prior to participation in the study
- Patients ≥ 18 years old
- Patients with a confirmed diagnosis of primary ITP, who are not responsive or in relapse after a first line of steroid therapy ± intravenous immunoglobulin (IVIG) (used as a rescue therapy)
- Platelet count < 30×10^9/L and assessed as needing treatment (per physician's discretion
Exclusion Criteria:
- ITP patients previously treated with any ITP second-line therapies, thrombopoietin receptor (TPO-R) agonists for ITP, except steroids / IVIG
- Patients who relapsed more than one year after the end of first-line full course of steroid therapy
- Patients with a diagnosis of secondary thrombocytopenia
- Patients who have life threatening bleeding complications per investigator discretion
- Patients who had a deep vein thrombosis or arterial thrombosis in the 6 months preceding enrollment
- Serum creatinine ≥ 1.5 mg/dL
- Total bilirubin > 1.5 × upper limit of normal (ULN)
- Aspartate transaminase (AST) > 3.0 × ULN
- Alanine transaminase (ALT) > 3.0 × ULN
- Patients who are human immune deficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) positive
- Patients with hepatic impairment (Child-Pugh score > 5)
- Patients who have active malignancy
- Patients with any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance with the study procedures per investigator discretion
- History or current diagnosis of cardiac disease indicating significant risk of safety for Patients participating in the study
- Patients with known active or uncontrolled infections not responding to appropriate therapy
- Patients with evidence of current alcohol/drug abuse
- Women of child-bearing potential and sexually active males unwilling to use adequate contraception during the study
- Female Patients 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
Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Hematology Oncology Association of Rockland Drug Shipment
- Case Western Reserve SC - 2
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
eltrombopag
Arm Description
Participants will be treated with eltrombopag to induce sustained response off treatment to reach a target platelet count of ≥ 100×10^9/L (CR), after 1st line steroids have failed.
Outcomes
Primary Outcome Measures
Percentage of participants with sustained response off treatment by 12 months
Sustained response off treatment is defined as reach platelet count ≥ 100×10^9/L (complete response [CR]) and then maintain platelet counts around 100×10^9/L for 2 months (no counts below 70×10^9/L) AND then taper off the drug until treatment discontinuation while, maintain platelet count ≥ 30×10^9/L in the absence of bleeding (no bleeding AEs) or use of any rescue therapy.
Secondary Outcome Measures
Duration of sustained response off treatment after treatment discontinuation for participants with sustained response off treatment
Duration of sustained response off treatment (in weeks) counted from last dose of eltrombopag to month 12 for participants with sustained response off treatment.
Sustained response off treatment is defined as reach platelet count ≥ 100×10^9/L (complete response [CR]) and then maintain platelet counts around 100×10^9/L for 2 months (no counts below 70×10^9/L) AND then taper off the drug until treatment discontinuation while, maintain platelet count ≥ 30×10^9/L in the absence of bleeding (no bleeding AEs) or use of any rescue therapy.
Duration of sustained response off treatment for participants with sustained response off treatment at month 12 and who enter 12 months follow-up period
Duration of sustained response off treatment (in weeks) counted from last dose of eltrombopag to relapse for participants with sustained response off treatment at month 12 and who enter 12 months follow-up period.
Sustained response off treatment is defined as reach platelet count ≥ 100×10^9/L (complete response [CR]) and then maintain platelet counts around 100×10^9/L for 2 months (no counts below 70×10^9/L) AND then taper off the drug until treatment discontinuation while, maintain platelet count ≥ 30×10^9/L in the absence of bleeding (no bleeding AEs) or use of any rescue therapy.
Median duration of sustained response off treatment for all patients
Duration of sustained response off treatment (in weeks) counted from last dose of eltrombopag to month 24 for all participants
Percentage of participants with sustained response off treatment until month 24
Sustained response off treatment is defined as reach platelet count ≥ 100×10^9/L (complete response [CR]) and then maintain platelet counts around 100×10^9/L for 2 months (no counts below 70×10^9/L) AND then taper off the drug until treatment discontinuation while, maintain platelet count ≥ 30×10^9/L in the absence of bleeding (no bleeding AEs) or use of any rescue therapy
Percentage of participants with platelet count ≥ 50×10^9/L
Percentage of subjects who reach platelet count ≥ 50×10^9/L at least once within the first month (month 1) without bleeding events and no rescue therapy
Percentage of participants with at least one platelet count ≥ 30×10^9/L after eltrombopag is re-introduced without bleeding and no rescue medication
Percentage of subjects with at least one platelet count ≥ 30×10^9/L after eltrombopag is re-introduced, in case of loss of response (< 30×10^9/L and/or bleeding event) without bleeding events and no rescue therapy
Change from baseline in platelet count to various time points
Change from baseline in platelet count to different time points
Percentage of participants who maintain a platelet count ≥ 30×10^9/L without bleeding and no rescue medication
Percentage of participants who maintain platelet count ≥ 30×10^9/L from the first time of reaching that level to month 3, 6, 9, 12, 15, 18, 21, 24 without bleeding an no rescue therapy
Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionaire
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) instrument is a 13-item validated tool used to measure an individual's level of fatigue during usual daily activities over the past 7 days (Cella 2002, Webster 2003). FACIT-Fatigue is a subscale of the FACIT measurement system. FACIT-fatigue is scored using a 4-point Likert scale (4=not at all fatigued to 0=very much fatigued) where the total possible score ranges from 0-5; higher scores represent better HRQoL.
Change from baseline in Functional Assessment of Cancer Therapy- Thrombocytopenia (FACT-Th6) questionnaire
FACT-Th6 instrument is used to measure worry/concern about bleeding and bruising, and the impact of this worry/concern on physical and social activity (Cella 2006). FACT-Th6 is a 6-item subset of the more detailed FACT-Th, which is an 18-item subscale of the validated FACT that specifically measures concerns related to thrombocytopenia in the past 7 days. The FACT-Th6 is scored using a 5-level Likert scale (0=not at all to 4=very much) and is calculated by summing scores for the 6-items; therefore, scores can range from 0-24, with higher scores representing better HRQoL
Change from baseline in Short Form 36 Health Survey (SF-36v2) questionnaire
SF-36v2 is a validated instrument used to measure general physical and mental health status (Ware 2000) via assessment of 8 domains-Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health-over the past 4 weeks or 7 days. The SF-36 is scored using norm-based scoring procedures and scores ranging from 0-100; higher scores represent better HRQoL
Overall change from baseline of the overall impact of side effects on treatment via Functional Assessment of Cancer Therapy-G (GP5)
The GP5 is a single question used to assess the overall bothersomeness of treatment side effects. The GP5 is scored using a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much), where lower scores reflect less bothersomeness from treatment side effects.
Overall change of treatment satisfaction using Treatment Satisfaction Questionnaire (TSQM-9)
TSQM-9 will be used to assess treatment satisfaction with medication. The three scales of the TSQM-9 include the effectiveness scale, convenience scale, and global satisfaction scale. The total score ranges from 0 to 63, with higher scores indicating better treatment satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03524612
Brief Title
A Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP
Acronym
TAPER
Official Title
A Phase II, Open-label, Prospective, Single-arm, Study to Assess Ability of Eltrombopag to Induce Sustained Remission in Subjects With ITP Who Are Refractory or Relapsed After First-line Steroids
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2018 (Actual)
Primary Completion Date
October 22, 2021 (Actual)
Study Completion Date
October 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will assess the ability of eltrombopag to induce sustained response off treatment in ITP subjects who relapsed or failed to respond to an initial treatment with steroids.
There is limited, mainly retrospective evidence that earlier use of eltrombopag after ITP diagnosis, will allow a larger proportion of subjects to achieve sustained response off treatment after tapering off drug. Clinically there is a need for a less toxic regimen that will provide responses and sustained response off treatment with a shorter treatment interval. This trial is designed to assess this.
Detailed Description
Note: The protocol defines the primary endpoint as "the proportion of patients with sustained remission by month 12", where sustained remission is defined as reaching a platelet count of ≥ 100 × 10^9/L CR]); maintaining the platelet counts around 100 × 10^9/L for 2 months (no counts < 70 × 10^9/L), and then tapering-off the drug until treatment discontinuation while maintaining the platelet count ≥ 30 × 10^9/L in the absence of bleeding adverse events (AEs) or use of any rescue therapy until Month 12.
Since some publications suggest to use "remission" for patients who maintain platelet counts above a higher level for a minimum amount of time while off-treatment, the primary endpoint terminology was amended to replace 'sustained remission' with 'sustained response off-treatment' to better reflect the underlying criteria defining it. The definition of the primary endpoint remains otherwise unchanged.
'Sustained response off-treatment' has been used for all applicable references to the primary endpoint throughout the clinicaltrials.gov posting for CETB115J2411.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenic Purpura (ITP)
Keywords
Thrombocytopenic, Immune, Platelets, Bleeding, ITP, eltrombopag, ETB115, induce sustained response off treatment, refractory or relapsed, first-line steroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eltrombopag
Arm Type
Other
Arm Description
Participants will be treated with eltrombopag to induce sustained response off treatment to reach a target platelet count of ≥ 100×10^9/L (CR), after 1st line steroids have failed.
Intervention Type
Drug
Intervention Name(s)
eltrombopag
Other Intervention Name(s)
ETB115
Intervention Description
eltrombopag is for oral use and comes in 12.5, 25, 50 and 75 mg tablets; prescribed dose is taken once daily
Primary Outcome Measure Information:
Title
Percentage of participants with sustained response off treatment by 12 months
Description
Sustained response off treatment is defined as reach platelet count ≥ 100×10^9/L (complete response [CR]) and then maintain platelet counts around 100×10^9/L for 2 months (no counts below 70×10^9/L) AND then taper off the drug until treatment discontinuation while, maintain platelet count ≥ 30×10^9/L in the absence of bleeding (no bleeding AEs) or use of any rescue therapy.
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Duration of sustained response off treatment after treatment discontinuation for participants with sustained response off treatment
Description
Duration of sustained response off treatment (in weeks) counted from last dose of eltrombopag to month 12 for participants with sustained response off treatment.
Sustained response off treatment is defined as reach platelet count ≥ 100×10^9/L (complete response [CR]) and then maintain platelet counts around 100×10^9/L for 2 months (no counts below 70×10^9/L) AND then taper off the drug until treatment discontinuation while, maintain platelet count ≥ 30×10^9/L in the absence of bleeding (no bleeding AEs) or use of any rescue therapy.
Time Frame
From last dose of eltrombopag to month 12
Title
Duration of sustained response off treatment for participants with sustained response off treatment at month 12 and who enter 12 months follow-up period
Description
Duration of sustained response off treatment (in weeks) counted from last dose of eltrombopag to relapse for participants with sustained response off treatment at month 12 and who enter 12 months follow-up period.
Sustained response off treatment is defined as reach platelet count ≥ 100×10^9/L (complete response [CR]) and then maintain platelet counts around 100×10^9/L for 2 months (no counts below 70×10^9/L) AND then taper off the drug until treatment discontinuation while, maintain platelet count ≥ 30×10^9/L in the absence of bleeding (no bleeding AEs) or use of any rescue therapy.
Time Frame
From last dose of eltrombopag to relapse, assessed up to month 24
Title
Median duration of sustained response off treatment for all patients
Description
Duration of sustained response off treatment (in weeks) counted from last dose of eltrombopag to month 24 for all participants
Time Frame
From last dose of eltrombopag to month 24
Title
Percentage of participants with sustained response off treatment until month 24
Description
Sustained response off treatment is defined as reach platelet count ≥ 100×10^9/L (complete response [CR]) and then maintain platelet counts around 100×10^9/L for 2 months (no counts below 70×10^9/L) AND then taper off the drug until treatment discontinuation while, maintain platelet count ≥ 30×10^9/L in the absence of bleeding (no bleeding AEs) or use of any rescue therapy
Time Frame
Month 15, 18, 21 and 24
Title
Percentage of participants with platelet count ≥ 50×10^9/L
Description
Percentage of subjects who reach platelet count ≥ 50×10^9/L at least once within the first month (month 1) without bleeding events and no rescue therapy
Time Frame
By 1 month
Title
Percentage of participants with at least one platelet count ≥ 30×10^9/L after eltrombopag is re-introduced without bleeding and no rescue medication
Description
Percentage of subjects with at least one platelet count ≥ 30×10^9/L after eltrombopag is re-introduced, in case of loss of response (< 30×10^9/L and/or bleeding event) without bleeding events and no rescue therapy
Time Frame
12 months and 24 months
Title
Change from baseline in platelet count to various time points
Description
Change from baseline in platelet count to different time points
Time Frame
Baseline, month 3, 6, 9, 12, 15, 18, 21 and 24 and end of treatment visit (up to 12 months)
Title
Percentage of participants who maintain a platelet count ≥ 30×10^9/L without bleeding and no rescue medication
Description
Percentage of participants who maintain platelet count ≥ 30×10^9/L from the first time of reaching that level to month 3, 6, 9, 12, 15, 18, 21, 24 without bleeding an no rescue therapy
Time Frame
From first time of reaching the level to month 3, 6, 9, 12, 15, 18, 21 and 24 and end of treatment visit (up to 12 months)
Title
Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionaire
Description
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) instrument is a 13-item validated tool used to measure an individual's level of fatigue during usual daily activities over the past 7 days (Cella 2002, Webster 2003). FACIT-Fatigue is a subscale of the FACIT measurement system. FACIT-fatigue is scored using a 4-point Likert scale (4=not at all fatigued to 0=very much fatigued) where the total possible score ranges from 0-5; higher scores represent better HRQoL.
Time Frame
Baseline to month 3, 6, 9, 12, 15, 18, 21 and 24 and end of treatment visit (up to 12 months)
Title
Change from baseline in Functional Assessment of Cancer Therapy- Thrombocytopenia (FACT-Th6) questionnaire
Description
FACT-Th6 instrument is used to measure worry/concern about bleeding and bruising, and the impact of this worry/concern on physical and social activity (Cella 2006). FACT-Th6 is a 6-item subset of the more detailed FACT-Th, which is an 18-item subscale of the validated FACT that specifically measures concerns related to thrombocytopenia in the past 7 days. The FACT-Th6 is scored using a 5-level Likert scale (0=not at all to 4=very much) and is calculated by summing scores for the 6-items; therefore, scores can range from 0-24, with higher scores representing better HRQoL
Time Frame
Baseline to month 3, 6, 9, 12, 15, 18, 21 and 24 and end of treatment visit (up to 12 months)
Title
Change from baseline in Short Form 36 Health Survey (SF-36v2) questionnaire
Description
SF-36v2 is a validated instrument used to measure general physical and mental health status (Ware 2000) via assessment of 8 domains-Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health-over the past 4 weeks or 7 days. The SF-36 is scored using norm-based scoring procedures and scores ranging from 0-100; higher scores represent better HRQoL
Time Frame
Baseline to month 3, 6, 9, 12, 15, 18, 21 and 24 and end of treatment visit (up to 12 months)
Title
Overall change from baseline of the overall impact of side effects on treatment via Functional Assessment of Cancer Therapy-G (GP5)
Description
The GP5 is a single question used to assess the overall bothersomeness of treatment side effects. The GP5 is scored using a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much), where lower scores reflect less bothersomeness from treatment side effects.
Time Frame
Baseline, month 12 and end of treatment visit (up to 12 months)
Title
Overall change of treatment satisfaction using Treatment Satisfaction Questionnaire (TSQM-9)
Description
TSQM-9 will be used to assess treatment satisfaction with medication. The three scales of the TSQM-9 include the effectiveness scale, convenience scale, and global satisfaction scale. The total score ranges from 0 to 63, with higher scores indicating better treatment satisfaction
Time Frame
Baseline, month 12 and end of treatment visit (up to 12 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent must be obtained prior to participation in the study
Patients ≥ 18 years old
Patients with a confirmed diagnosis of primary ITP, who are not responsive or in relapse after a first line of steroid therapy ± intravenous immunoglobulin (IVIG) (used as a rescue therapy)
Platelet count < 30×10^9/L and assessed as needing treatment (per physician's discretion
Exclusion Criteria:
ITP patients previously treated with any ITP second-line therapies, thrombopoietin receptor (TPO-R) agonists for ITP, except steroids / IVIG
Patients who relapsed more than one year after the end of first-line full course of steroid therapy
Patients with a diagnosis of secondary thrombocytopenia
Patients who have life threatening bleeding complications per investigator discretion
Patients who had a deep vein thrombosis or arterial thrombosis in the 6 months preceding enrollment
Serum creatinine ≥ 1.5 mg/dL
Total bilirubin > 1.5 × upper limit of normal (ULN)
Aspartate transaminase (AST) > 3.0 × ULN
Alanine transaminase (ALT) > 3.0 × ULN
Patients who are human immune deficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) positive
Patients with hepatic impairment (Child-Pugh score > 5)
Patients who have active malignancy
Patients with any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject's safety, obtaining informed consent or compliance with the study procedures per investigator discretion
History or current diagnosis of cardiac disease indicating significant risk of safety for Patients participating in the study
Patients with known active or uncontrolled infections not responding to appropriate therapy
Patients with evidence of current alcohol/drug abuse
Women of child-bearing potential and sexually active males unwilling to use adequate contraception during the study
Female Patients 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
Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Hematology Oncology Association of Rockland Drug Shipment
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Facility Name
Case Western Reserve SC - 2
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5000
Country
United States
Facility Name
Novartis Investigative Site
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Novartis Investigative Site
City
Salvador
State/Province
BA
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
Novartis Investigative Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20211-030
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05319-000
Country
Brazil
Facility Name
Novartis Investigative Site
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4800827
Country
Chile
Facility Name
Novartis Investigative Site
City
Vina del Mar
State/Province
Valparaiso
ZIP/Postal Code
2540364
Country
Chile
Facility Name
Novartis Investigative Site
City
Caen Cedex
ZIP/Postal Code
14033
Country
France
Facility Name
Novartis Investigative Site
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Novartis Investigative Site
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Novartis Investigative Site
City
Patras
ZIP/Postal Code
265 00
Country
Greece
Facility Name
Novartis Investigative Site
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
Novartis Investigative Site
City
Trieste
State/Province
TS
ZIP/Postal Code
34129
Country
Italy
Facility Name
Novartis Investigative Site
City
Nagoya-city
State/Province
Aichi
ZIP/Postal Code
466-8650
Country
Japan
Facility Name
Novartis Investigative Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Novartis Investigative Site
City
Ciudad de Mexico
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Novartis Investigative Site
City
Muscat
ZIP/Postal Code
123
Country
Oman
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Salamanca
State/Province
Castilla Y Leon
ZIP/Postal Code
37007
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novartis Investigative Site
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Novartis Investigative Site
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Novartis Investigative Site
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Novartis Investigative Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Aydin
ZIP/Postal Code
09100
Country
Turkey
Facility Name
Novartis Investigative Site
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Novartis Investigative Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
A Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP
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