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Immunogenicity Assessment of Peg-filgrastim vs. Neulasta® as Adjunct to Chemotherapy in Patients With Breast Cancer

NCT03511378 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2021-06-15

Study results available
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Summary

The purpose of this study is to compare the immunogenicity of Peg-filgrastim versus Neulasta® as an adjunct to chemotherapy in patients with breast cancer

Conditions

Interventions

DRUG

Lupin's Pegfilgrastim

Administration of Pegfilgrastim

DRUG

Neulasta®

Administration of Neulasta®

Sponsors & Collaborators

  • Lupin Ltd.

    lead INDUSTRY

Principal Investigators

  • Dhananjay Bakhle, MD · Lupin Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-06
Primary Completion
2019-01-09
Completion
2019-01-09
FDA Drug
Yes

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

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 NCT03511378 on ClinicalTrials.gov