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AzTrials

Neutropenia (Low White Blood Cell Count)Phase 1NCT02766634

A Research Study To Test How Multiple Doses Of Filgrastim Hospira Works In The Body Of Healthy Study Subjects When Given by Subcutaneous Injection (SC) (Shot) Compared To An Already U.S.-Approved Drug Neupogen® (Amgen)

A Phase 1 study testing Filgrastim Hospira (US) and U.S.-approved Neupogen® in people with Neutropenia (Low White Blood Cell Count), run by Pfizer at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds of white blood cells (WBC) known as neutrophils. This type of white cell is important in fighting infections. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Neutropenia (Low White Blood Cell Count)
What is being tested?
Filgrastim Hospira (US) and U.S.-approved Neupogen®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesUnited States
Study dates
Mar 2016to Jun 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • A subject will be eligible for study participation if all of the following criteria are met at Screening:
  • Provides written informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB) prior to any study related activities
  • Healthy male or female volunteers between 18 and 65 years of age (both inclusive)
  • Body mass index (BMI) between 19 and 30 kg/m2, inclusive, and body weight of not < 50 kg or > 100 kg
  • Non smoker (defined as a subject who has not smoked and has not used nicotine containing products for at least 3 months prior to study drug administration and has a negative urine screen for cotinine) at Screening
  • Female subjects of childbearing potential and male subjects and their partners of childbearing potential, agree to pregnancy prevention throughout the duration of the study (through the Final Visit). Subjects and their partners must agree to use of an effective method of contraception, to avoid impregnation of females throughout the course of the study. Subjects using oral contraceptives must be on a stable regimen for at least 3 months prior to Screening. While the best way to avoid pregnancy is to abstain from sexual activity, adequate forms of contraception to be used include oral contraception, depot contraception, intrauterine device (IUD), and barrier contraceptive methods, such as condoms and barrier creams/contraceptive jellies, and spermicidals. Subjects and their partners who can become pregnant must use contraception while on study drug from admission to the Final Visit. Male subjects must also refrain from donating sperm from admission to the Final Visit
  • Agrees to abstain from alcohol consumption throughout duration of the study and has a negative urine for alcohol at Screening

Who cannot join

  • A subject will NOT be eligible for study participation if any of the following criteria are met at Screening:
  • Any active systemic or immunologic disease or condition, including but not limited to the following general categories: cardiovascular/pulmonary, hepatorenal, or systemic infection, or lactation
  • Hematologic laboratory abnormalities including leukocytosis (defined as total leukocytes > 11,000/µL), leukopenia (defined as total leukocytes < 4000/μL), or neutropenia (defined as absolute neutrophil count [ANC] < 1500/µL) or thrombocytopenia (defined as platelet count of < 150/µL)
  • Clinically significant, as judged by the Investigator, vital sign, chest X-ray, or 12-lead electrocardiogram (ECG) abnormality
  • History of biological growth factor exposure, including but not limited to filgrastim and other granulocyte-colony stimulating factors (G-CSFs) in the context of treatment, prophylaxis, peripheral blood stem cell mobilization, or previous investigational study setting
  • Drug sensitivity, allergic reaction to, or known hypersensitivity/idiosyncratic reaction to Escherichia coli-derived proteins, filgrastim, pegfilgrastim, other granulocyte colony-stimulating factors or any component of the product: Subjects with the rare heredity problem of fructose intolerance are excluded due to the excipient sorbitol
  • History of splenic rupture (or subject who is asplenic), pulmonary infiltrate or pneumonia, sickle cell disorders, chronic neutropenia, thrombocytopenia, or vasculitis

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • SeaView Research, Inc.

    Miami, Florida, 33126

  • SeaView Research, Inc.

    Miami, Florida, 33134

Other trials in United States

About this study

Official title: A Randomized Open-label, Multiple-dose, Crossover Study Evaluatig The Pharmacodynamics And Pharmacokinetics Of Filgrastim Hospira Compared To Us-approved Neupogen (Registered) Following Subcutaneous Administration To Healthy Volunteers

This is a study comparing two study drugs, Filgrastim Hospira and Neupogen®. Neupogen® is approved by the US Food and Drug Administration (FDA) to treat low numbers of specific kinds of white blood cells (WBC) known as neutrophils. This type of white cell is important in fighting infections. A low neutrophil count is known as neutropenia. Both drugs work by increasing the number of neutrophils that are produced in the body.

This is important for patients who have low neutrophils due to chemotherapy, other treatments such as bone marrow transplant or certain other conditions with symptoms/problems related to low neutrophil counts. The main aim of the study is to test how Filgrastim Hospira works in the body compared to Neupogen®.

Read the detailed description

This is a randomized, open-label, multiple-dose, crossover study evaluating the pharmacodynamics and Pharmacokinetics equivalence following SC administration of test and reference product in healthy volunteers. The study will be conducted at a single Phase 1 unit. There will be 30 healthy subjects in each of the two sequences.

After meeting the selection criteria, subjects will be randomly assigned to 1 of the 2 treatment sequences:

  • Filgrastim Hospira (US) in Period 1 followed by US-approved Neupogen® in Period 2.
  • US-approved Neupogen® in Period 1 followed by Filgrastim Hospira (US) in Period 2.

Subjects will receive one of each of the drugs once a day for 5 days in each of the treatment sequences.

Being tested
Filgrastim Hospira (US), U.S.-approved Neupogen®
Keywords
filgrastim
Medical subject headings
Neutropenia, Leukopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Filgrastim Hospira (US)Biological

    5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection once a day for 5 days

  • U.S.-approved Neupogen®Biological

    5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection once a day for 5 days

Study groups in NCT02766634
Study groupRoleWhat they receive
Filgrastim Hospira (US) followed by U.S.-approved Neupogen®ExperimentalNot described
Receives: Biological: Filgrastim Hospira (US); Biological: U.S.-approved Neupogen®
U.S.-approved Neupogen® followed by Filgrastim Hospira (US)ExperimentalNot described
Receives: Biological: Filgrastim Hospira (US); Biological: U.S.-approved Neupogen®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Area under the effect curve for CD34+ (AUECCD34+)

    Measured: prior to study drug administration on Days 1, 2, 3, 4, 5, and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period

  2. Maximum observed value for CD34+ (CD34+max)

    Measured: prior to study drug administration on Days 1, 2, 3, 4, 5, and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period

  3. Area under the serum filgrastim concentration versus time curve from time zero to 24 hours (AUC0-24)

    Measured: prior to study drug administration and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period

  4. Maximum serum filgrastim concentration (Cmax) following study drug administration on Day 5

    Measured: prior to study drug administration and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period

Secondary outcomes (4)

  1. Time to maximum CD34+ count (Tmax[CD34+])

    Measured: prior to study drug administration on Days 1, 2, 3, 4, 5, and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period

  2. The concentration prior to dose on Day 5 (Ctrough)

    Measured: prior to study drug administration and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period.

  3. Time to maximum serum filgrastim concentration (Tmax)

    Measured: prior to study drug administration and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period.

  4. Elimination half-life (t1/2) from serum filgrastim concentrations following dose administration on Day 5

    Measured: prior to study drug administration and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02766634
Sponsor's protocol ID
ZIN-FIL-1501
Other IDs
C1121003
Status last verified
Jul 2016
First submitted
6 May 2016
Last updated
21 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Yao HM, Ottery FD, Borema T, Harris S, Levy J, May TB, Moosavi S, Zhang J, Summers M. PF-06881893 (Nivestym), a Filgrastim Biosimilar, Versus US-Licensed Filgrastim Reference Product (US-Neupogen(R)): Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of Single or Multiple Subcutaneous Doses in Healthy Volunteers. BioDrugs. 2019 Apr;33(2):207-220. doi: 10.1007/s40259-019-00343-8.

    PubMed 30900158

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Filgrastim Hospira (US) and U.S.-approved Neupogen® in people with Neutropenia (Low White Blood Cell Count), run by Pfizer at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Area under the effect curve for CD34+ (AUECCD34+) (time frame: prior to study drug administration on Days 1, 2, 3, 4, 5, and 24, 48, 72, 96, and 120 hours after dose administration on Day 5 of each period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02766634, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2016.

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