A Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim in Pediatric Solid Tumor/Lymphoma Patients

NCT02963389 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2019-01-15

No results posted yet for this study

Summary

This is an open-label, single ascending dose study to evaluate safety, tolerability, and pharmacokinetics/pharmacodynamics of Tripegfilgrastim in pediatric solid tumor/lymphoma patients

Conditions

Interventions

DRUG

Tripegfilgrastim

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-04
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • South Korea

Study Locations

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Entities

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 NCT02963389 on ClinicalTrials.gov