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A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids (VAYHIT2)

Primary Purpose

Primary Immune Thrombocytopenia

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ianalumab
Eltrombopag
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Immune Thrombocytopenia focused on measuring Primary immune thrombocytopenia (ITP),, ianalumab, VAY736, B-cell depletion, B-cell Activating Factor Receptor (BAFF-R) blockade, eltrombopag

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion criteria Male or female patients aged 18 years and older on the day of signing the informed consent. A signed informed consent must be obtained prior to participation in the study. A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy ± IVIG. Platelet count <30 G/L and assessed need for treatment (per physician's discretion). Key Exclusion criteria ITP patients who received second-line ITP treatments (other than steroid therapy± IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonists (TPO-RAs) for a limited time (max one week) before screening are eligible. Patients with key lab abnormalities and patients with Evans syndrome or any other cytopenia Patients with history of clinically significant hematological disorders, or with marked altered hematologic parameters Patients with current or history of life-threatening bleeding Patient that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAB)-positive Patients with known active or uncontrolled infection requiring systemic treatment during screening period Patients with hepatic impairment Patients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medication Female patients who are pregnant or nursing Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Hematology Oncology Association of RocklandRecruiting
  • Community Cancer Trials of UtahRecruiting
  • Novartis Investigative SiteRecruiting
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Treatment arm 1

Treatment arm 2

Treatment arm 3

Arm Description

Participants will receive eltrombopag and ianalumab lower dose

Participants will receive eltrombopag and ianalumab higher dose

Participants will receive eltrombopag and placebo

Outcomes

Primary Outcome Measures

Time from randomization until treatment failure
Time from randomization until treatment failure is defined as the time from randomization date until the first of the following events indicative of treatment failure: platelet count below 30 G/L start of a new ITP treatment need for a rescue treatment ineligibility to taper or inability to discontinue eltrombopag death

Secondary Outcome Measures

Complete Response rate at each timepoint
Percentage of participants with any platelet count of at least 100 G/L in the absence of rescue treatment or new ITP treatment
Response rate at each timepoint
Percentage of participants with any platelet count of at least 50 G/L in the absence of rescue treatment or new ITP treatment
Best response rate across all timepoints
Percentage of participants with a best response rate of either response or complete response
Time to first response/time to first complete response
Time from randomization to date of first response and time from randomization to date of first complete response
Duration of response
Time from achievement of response to treatment failure
Duration of complete response
Time from achievement of complete response to loss of complete response
Rate of participants who successfully taper and discontinue eltrombopag in each treatment arm
Probability to be treatment failure-free (as defined for the primary efficacy endpoint)
Percentage of participants with bleeding events according to World Health Organization (WHO)
Percentage of participants reporting bleeding events according to WHO bleeding scale
Number of participants receiving rescue treatment
Number of participants who are in need of rescue treatment in each treatment arm
Percentage of participants receiving rescue treatment
Percentage of participants who are in need of rescue treatment
Change from baseline in the frequency of CD19+ B-cell counts
Post-baseline frequency of CD19+ B-cell counts (percentage within CD45) compared to baseline
Change from baseline in the absolute number of CD19+ B-cell counts
Post-baseline absolute number of CD19+ B-cell counts compared to baseline
Change from baseline on total score of the PROMIS SF v1.0 Fatigue 13a
The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Fatigue 13a includes 13 items that assess fatigue in adults.
Change from baseline in ITP PAQ domain scores of symptoms, fatigue, bother (uncomfortable), activity
The ITP-PAQ is a 44 item scale for measuring HRQoL in adults with ITP across ten scales: Symptoms, Bother-Physical Health, Fatigue/Sleep, Activity, Fear, Psychological Health, Work, Social Activity, Women´s Reproductive Health, overall QoL. Each item is rated on a Likert type scale. Each scale is scored from 0 to 100. Higher scores represent better HRQoL.
Time to first occurence of B-cell recovery defined as ≥80% of baseline ≥50 cells/µL
Time to B-cell recovery defined as ≥80% of baseline or ≥50 cells/µL
Change from baseline in immunoglobulins
Change from baseline in immunoglobulin levels
PK parameters: AUClast
AUClast: Area under the curve from time zero to the last measurable concentration sampling time (tlast)
PK parameters: AUCtau
AUCtau: Area under the curve calculated to the end of a dosing interval (tau)
PK parameters: Cmax
Maximum (peak) observed plasma, blood, serum or other body fluid drug concentration
PK parameters: Tmax
Time to reach maximum (peak) observed plasma, blood, serum or other body fluid drug concentration
PK parameters: Accumulation ratio Racc
Accumulation ratio calculated using AUC values obtained after the last and first dose
Incidence of anti-ianalumab antibodies in serum (ADA assay) over time
Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assessing the immunogenicity of ianalumab
Titer of anti-ianalumab antibodies in serum (ADA assay) over time
Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assessing the immunogenicity of ianalumab

Full Information

First Posted
November 23, 2022
Last Updated
July 5, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05653219
Brief Title
A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
Acronym
VAYHIT2
Official Title
A Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment (VAYHIT2)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
June 6, 2025 (Anticipated)
Study Completion Date
February 2, 2028 (Anticipated)

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
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.
Detailed Description
This is a multicenter, randomized, double-blinded phase 3 study to assess efficacy and safety of two different doses of ianalumab versus placebo in addition to eltrombopag in adults with primary ITP (platelet count <30 G/L) who failed previous first-line treatment with corticosteroids. After completion of the screening period, the participants will enter the randomized treatment period (ianalumab/placebo with eltrombopag) followed by the eltrombopag tapering period. Afterwards, all participants will enter the follow-up period to be monitored for efficacy and safety or safety only depending on how the participants responded to the study treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immune Thrombocytopenia
Keywords
Primary immune thrombocytopenia (ITP),, ianalumab, VAY736, B-cell depletion, B-cell Activating Factor Receptor (BAFF-R) blockade, eltrombopag

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm 1
Arm Type
Experimental
Arm Description
Participants will receive eltrombopag and ianalumab lower dose
Arm Title
Treatment arm 2
Arm Type
Experimental
Arm Description
Participants will receive eltrombopag and ianalumab higher dose
Arm Title
Treatment arm 3
Arm Type
Placebo Comparator
Arm Description
Participants will receive eltrombopag and placebo
Intervention Type
Biological
Intervention Name(s)
Ianalumab
Other Intervention Name(s)
VAY736
Intervention Description
Concentrate for solution for infusion for intravenous use
Intervention Type
Drug
Intervention Name(s)
Eltrombopag
Other Intervention Name(s)
ETB115
Intervention Description
Film-coated tablet for oral use
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Concentrate for solution for infusion for intravenous use.
Primary Outcome Measure Information:
Title
Time from randomization until treatment failure
Description
Time from randomization until treatment failure is defined as the time from randomization date until the first of the following events indicative of treatment failure: platelet count below 30 G/L start of a new ITP treatment need for a rescue treatment ineligibility to taper or inability to discontinue eltrombopag death
Time Frame
Randomization to until end of study (up to 39 months after randomization of last participant)
Secondary Outcome Measure Information:
Title
Complete Response rate at each timepoint
Description
Percentage of participants with any platelet count of at least 100 G/L in the absence of rescue treatment or new ITP treatment
Time Frame
Randomization to until end of study (up to 39 months after randomization of last participant)
Title
Response rate at each timepoint
Description
Percentage of participants with any platelet count of at least 50 G/L in the absence of rescue treatment or new ITP treatment
Time Frame
Randomization to until end of study (up to 39 months after randomization of last participant)
Title
Best response rate across all timepoints
Description
Percentage of participants with a best response rate of either response or complete response
Time Frame
Randomization to until end of study (up to 39 months after randomization of last participant)
Title
Time to first response/time to first complete response
Description
Time from randomization to date of first response and time from randomization to date of first complete response
Time Frame
Time from randomization up to the longest observed treatment period duration
Title
Duration of response
Description
Time from achievement of response to treatment failure
Time Frame
Randomization to until end of study (up to 39 months after randomization of last participant)
Title
Duration of complete response
Description
Time from achievement of complete response to loss of complete response
Time Frame
Randomization to end of study (up to 39 months after randomization of last participant)
Title
Rate of participants who successfully taper and discontinue eltrombopag in each treatment arm
Description
Probability to be treatment failure-free (as defined for the primary efficacy endpoint)
Time Frame
up to week 24
Title
Percentage of participants with bleeding events according to World Health Organization (WHO)
Description
Percentage of participants reporting bleeding events according to WHO bleeding scale
Time Frame
Randomization to until end of study (up to 39 months after randomization of last participant)
Title
Number of participants receiving rescue treatment
Description
Number of participants who are in need of rescue treatment in each treatment arm
Time Frame
Randomization to until end of study (up to 39 months after randomization of last participant)
Title
Percentage of participants receiving rescue treatment
Description
Percentage of participants who are in need of rescue treatment
Time Frame
Randomization to until end of study (up to 39 months after randomization of last participant)
Title
Change from baseline in the frequency of CD19+ B-cell counts
Description
Post-baseline frequency of CD19+ B-cell counts (percentage within CD45) compared to baseline
Time Frame
Randomization to until end of study (up to 39 months after randomization of last participant)
Title
Change from baseline in the absolute number of CD19+ B-cell counts
Description
Post-baseline absolute number of CD19+ B-cell counts compared to baseline
Time Frame
Randomization to until end of study (up to 39 months after randomization of last participant)
Title
Change from baseline on total score of the PROMIS SF v1.0 Fatigue 13a
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Fatigue 13a includes 13 items that assess fatigue in adults.
Time Frame
From screening (baseline) until end of study (up 39 months after randomization of last participant)
Title
Change from baseline in ITP PAQ domain scores of symptoms, fatigue, bother (uncomfortable), activity
Description
The ITP-PAQ is a 44 item scale for measuring HRQoL in adults with ITP across ten scales: Symptoms, Bother-Physical Health, Fatigue/Sleep, Activity, Fear, Psychological Health, Work, Social Activity, Women´s Reproductive Health, overall QoL. Each item is rated on a Likert type scale. Each scale is scored from 0 to 100. Higher scores represent better HRQoL.
Time Frame
From screening (baseline) until end of study (up 39 months after randomization of last participant)
Title
Time to first occurence of B-cell recovery defined as ≥80% of baseline ≥50 cells/µL
Description
Time to B-cell recovery defined as ≥80% of baseline or ≥50 cells/µL
Time Frame
Randomization to until end of study (up to 39 months after randomization of last participant)
Title
Change from baseline in immunoglobulins
Description
Change from baseline in immunoglobulin levels
Time Frame
Randomization to until end of study (up to 39 months after randomization of last participant)
Title
PK parameters: AUClast
Description
AUClast: Area under the curve from time zero to the last measurable concentration sampling time (tlast)
Time Frame
After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
Title
PK parameters: AUCtau
Description
AUCtau: Area under the curve calculated to the end of a dosing interval (tau)
Time Frame
After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
Title
PK parameters: Cmax
Description
Maximum (peak) observed plasma, blood, serum or other body fluid drug concentration
Time Frame
After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
Title
PK parameters: Tmax
Description
Time to reach maximum (peak) observed plasma, blood, serum or other body fluid drug concentration
Time Frame
After first dose (pre-dose, 2, 168, 336 and 504 hours post dose) and after last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
Title
PK parameters: Accumulation ratio Racc
Description
Accumulation ratio calculated using AUC values obtained after the last and first dose
Time Frame
After last dose (pre-dose, 2, 336, 672, 1344, 2016, 3360 hours post dose)
Title
Incidence of anti-ianalumab antibodies in serum (ADA assay) over time
Description
Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assessing the immunogenicity of ianalumab
Time Frame
up to week 33
Title
Titer of anti-ianalumab antibodies in serum (ADA assay) over time
Description
Anti-drug antibodies (ADA) will be evaluated in samples collected from all participants assessing the immunogenicity of ianalumab
Time Frame
up to week 33

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion criteria Male or female patients aged 18 years and older on the day of signing the informed consent. A signed informed consent must be obtained prior to participation in the study. A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy ± IVIG. Platelet count <30 G/L and assessed need for treatment (per physician's discretion). Key Exclusion criteria ITP patients who received second-line ITP treatments (other than steroid therapy± IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonists (TPO-RAs) for a limited time (max one week) before screening are eligible. Patients with key lab abnormalities and patients with Evans syndrome or any other cytopenia Patients with history of clinically significant hematological disorders, or with marked altered hematologic parameters Patients with current or history of life-threatening bleeding Patient that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAB)-positive Patients with known active or uncontrolled infection requiring systemic treatment during screening period Patients with hepatic impairment Patients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medication Female patients who are pregnant or nursing Other protocol-defined inclusion/exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
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
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion VanWoudenberg
Phone
845-362-1750
Email
research@highlandmedicalpc.com
First Name & Middle Initial & Last Name & Degree
Sung Ho Lee
Facility Name
Community Cancer Trials of Utah
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sibian Torres
Phone
801-689-3909
Email
Sibian@communitycancertrials.com
First Name & Middle Initial & Last Name & Degree
Carl Gray
Facility Name
Novartis Investigative Site
City
Linz
ZIP/Postal Code
4010
Country
Austria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Binzhou
State/Province
Shandong
ZIP/Postal Code
256603
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ji Nan
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Brno Bohunice
State/Province
Czech Republic
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Praha
ZIP/Postal Code
12808
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Jena
ZIP/Postal Code
07740
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
453-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Narita
State/Province
Chiba
ZIP/Postal Code
286-8523
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Osaka-city
State/Province
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kofu-city
State/Province
Yamanashi
ZIP/Postal Code
400-8506
Country
Japan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Jeollanam
ZIP/Postal Code
519763
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kota Kinabalu
State/Province
Sabah
ZIP/Postal Code
88586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Johor Bahru
ZIP/Postal Code
80100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Selangor
ZIP/Postal Code
68000
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gralum
ZIP/Postal Code
1714
Country
Norway
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Craiova
ZIP/Postal Code
200136
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
S308433
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Salamanca
State/Province
Castilla Y Leon
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Santiago de Compostela
State/Province
Galicia
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Aydin
ZIP/Postal Code
09100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Recruiting

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
IPD Sharing URL
https://www.clinicalstudydatarequest.com

Learn more about this trial

A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids

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