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

NCT03471078 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2023-09-28

Study results available
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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.

Conditions

  • Chemotherapy-induced Thrombocytopenia

Interventions

DRUG

Avatrombopag

Oral avatrombopag tablet

DRUG

Placebo Oral Tablet

Placebo comparator tablet

Sponsors & Collaborators

  • Sobi, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-12
Primary Completion
2020-08-28
Completion
2023-01-31
FDA Drug
Yes

Countries

  • United States
  • China
  • Hungary
  • Poland
  • Russia
  • Serbia
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03471078 on ClinicalTrials.gov