Trials / Completed
CompletedNCT03511378
Immunogenicity Assessment of Peg-filgrastim vs. Neulasta® as Adjunct to Chemotherapy in Patients With Breast Cancer
An Open-label, Randomized, Comparative, Parallel Group Study to Assess the Immunogenicity of Lupin's Peg-filgrastim Versus Neulasta® as an Adjunct to Chemotherapy in Patients With Breast Cancer
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 138 (actual)
- Sponsor
- Lupin Ltd. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed description
An open-label, randomized, comparative, parallel group study to assess the Immunogenicity of Lupin's Peg-filgrastim versus Neulasta® as an Adjunct to Chemotherapy in Patients with Breast Cancer Primary Objective: To assess the immunogenicity of Lupin's Peg-filgrastim with Neulasta® in patients with breast cancer. Secondary Objectives: To assess the safety of Lupin's Peg-filgrastim with Neulasta® in patients with breast cancer
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lupin's Pegfilgrastim | Administration of Pegfilgrastim |
| DRUG | Neulasta® | Administration of Neulasta® |
Timeline
- Start date
- 2018-03-06
- Primary completion
- 2019-01-09
- Completion
- 2019-01-09
- First posted
- 2018-04-27
- Last updated
- 2021-06-15
- Results posted
- 2021-06-15
Locations
17 sites across 1 country: India
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03511378. Inclusion in this directory is not an endorsement.