A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
NCT ID: NCT04596995
Last Updated: 2024-02-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
43 participants
INTERVENTIONAL
2021-01-06
2022-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rozanolixizumab Treatment Arm
All study participants will receive fixed-unit doses of rozanolixizumab across body weight tiers at pre-specified time points during the Treatment Period. Doses will be adjusted based on platelet count values or medical needs.
Rozanolixizumab
Study participants receive rozanolixizumab by subcutaneous infusion during the Treatment Period.
Interventions
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Rozanolixizumab
Study participants receive rozanolixizumab by subcutaneous infusion during the Treatment Period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The study participant is considered reliable and capable of adhering to the protocol, visit schedule, or medication intake according to the judgment of the investigator
* Study participants may be male or female:
1. A male participant must agree to use contraception during the Treatment Period and for at least 3 months after the final dose of study treatment and refrain from donating sperm during this period
2. A female participant is eligible to participate if she is not pregnant as confirmed by a negative urine pregnancy test and not planning to get pregnant during the participation in the study, not breastfeeding, and at least one of the following conditions applies:
Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 3 months after the final dose of study treatment
Exclusion Criteria
* Study participant has, at last available assessment of TP0003 or TP0006, 3.0x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP)
18 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273
Locations
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Tp0004 50243
Boston, Massachusetts, United States
Tp0004 20179
Fuzhou, , China
Tp0004 20185
Jinan, , China
Tp0004 20194
Wuxi, , China
Tp0004 20050
Tbilisi, , Georgia
Tp0004 40369
Berlin, , Germany
Tp0004 40202
Győr, , Hungary
Tp0004 40178
Nyíregyháza, , Hungary
Tp0004 40208
Florence, , Italy
Tp0004 20039
Iruma-gun, , Japan
Tp0004 20051
Chisinau, , Moldova
Tp0004 40218
Gdansk, , Poland
Tp0004 40222
Skorzewo, , Poland
Tp0004 40219
Słupsk, , Poland
Tp0004 40223
Warsaw, , Poland
Tp0004 20052
Moscow, , Russia
Tp0004 20053
Saint Petersburg, , Russia
Tp0004 40268
Madrid, , Spain
Tp0004 20095
Taipei, , Taiwan
Tp0004 20099
Taipei, , Taiwan
Tp0004 20061
Cherkasy, , Ukraine
Tp0004 20060
Dnipropetrovsk, , Ukraine
Tp0004 20062
Ivano-Frankivsk, , Ukraine
Tp0004 20063
Kyiv, , Ukraine
Tp0004 20064
Kyiv, , Ukraine
Tp0004 20100
Zaporizhzhia, , Ukraine
Tp0004 40234
Plymouth, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-000883-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TP0004
Identifier Type: -
Identifier Source: org_study_id
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