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Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers

Chemotherapy-induced Thrombocytopenia Clinical Trial

Official title:
Randomized, Double-Blind, Placebo-Controlled Study With Open-Label Extension to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Active Non-Hematological Cancers

Clinical Trial Summary

Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of avatrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of ovarian, lung (small cell and non-small cell) and bladder cancer.

Clinical Trial Description

Subjects will receive placebo controlled test treatment for one cycle of chemotherapy followed by an observational cycle. Subjects will have the option to continue into an open label extension period for all remaining chemotherapy cycles within the current regimen. After the follow-up visit, all subjects will continue to a long-term safety follow-up period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03471078
Study type Interventional
Source Sobi, Inc.
Contact
Status Completed
Phase Phase 3
Start date October 12, 2018
Completion date January 31, 2023
View Details
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