Study of the Effect of a 5-Day Regimen of Study Drug on Peripheral Stem Cell Mobilization in Healthy Participants

NCT03029000 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: TV44688-ONC-30054
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 9

Brief Summary

A multi-center, open-label, single-arm clinical study to assess effects of a 5-day regimen of 10 micrograms per kilogram (mcg/kg) of tbo-filgrastim administered subcutaneously daily on the mobilization of cluster of differentiation 34+ (CD34+) cells in at least 60 healthy male and female participants. The pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of tbo-filgrastim will be assessed.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With at Least 2*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg) of Recipient Body Weight Collected in the First Apheresis on Day 5

  The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.

  Day 5

Secondary Outcomes (7)

• Percentage of Participants With at Least 2*10^6 CD34+ Cells/kg of Donor Baseline Body Weight Collected After the First Apheresis on Day 5

  Day 5

• Percentage of Participants With at Least 5*10^6 CD34+ Cells/kg of Recipient Body Weight Collected After the First Apheresis on Day 5

  Day 5

• Number of Aphereses Necessary to Collect at Least 5*10^6 CD34+ Cells/kg of Recipient Body Weight

  Days 5 to 8

• Percentage of Participants With Adverse Events (AEs)

  From first administration of study drug (Day 1) up to early termination/end of study (up to approximately 3 months)

• Percentage of Participants With Anti-Drug Antibodies (ADA)

  Baseline (Day -3) up to early termination/end of study (up to approximately 3 months)

Study Arms (1)

Tbo-filgrastim (GRANIX)

EXPERIMENTAL

Participants will receive tbo-filgrastim 10 mcg/kg of body weight, subcutaneously on the morning of Days 1 to 5. The actual dose of tbo-filgrastim administered to each, individual participant will be calculated at baseline according to his or her body weight and that specific dose (10 mcg/kg of body weight) for each, individual participant will remain the same for all consecutive daily doses. If the collection goal will not meet after the first apheresis on Day 5, tbo-filgrastim 10 mcg/kg of body weight will be administered subcutaneously for up to 3 additional days (Days 6 to 8) followed by daily apheresis to reach the cumulative collection goal.

Drug: Tbo-filgrastim

Interventions

Tbo-filgrastim DRUG

solution for subcutaneous injection

Also known as: XM02

Tbo-filgrastim (GRANIX)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent is obtained from the participant
• The participant has a body weight of at least 50 kilograms (kg)
• The participant has a body mass index (BMI) of more than 18.5 and less than 35.0 kilograms per square meter (kg/m\^2)
• The participant is in good health as determined by medical and psychiatric history, physical examination, electrocardiogram (ECG) recordings, serum chemistry, hematology, coagulation, urinalysis, and serology
• Women may be included only if they have a negative beta human chorionic gonadotropin (beta-hCG) test at baseline, are sterile (defined as documented hysterectomy, bilateral oophorectomy or bilateral salpingectomy, or congenitally sterile), or postmenopausal (defined as no menses for 12 months without alternative medical cause and increased follicle stimulating hormone \[FSH\] of above 35 units per liter \[U/L\] in women not using hormonal contraception or hormonal replacement therapy). Women of childbearing potential whose male partners are potentially fertile (that is, no vasectomy) must use highly effective birth control methods for the duration of the study and for 30 days after the last tbo-filgrastim administration
• The participant has a negative alcohol urine test and a negative urine drug screen
• The participant must be willing and able to comply with study restrictions
• The participant is human leukocyte antigen (HLA) -matched or haploidentical-related to the recipient

You may not qualify if:

• The participant currently has or had a history of any clinically relevant gastrointestinal, hematologic, respiratory, psychiatric, renal, hepatic, cardiac, metabolic (such as, fructose intolerance), neurological, or any other disease or condition which may influence the physiological metabolic turnover (such as, severe endocrine diseases, febrile condition, severe infections), which may interfere with the study objectives, or which could expose the participant to undue risk through the participation in the clinical study
• The participant has had: (1) a trauma or surgery in the past 2 months; (2) a clinically relevant illness within 4 weeks before the first dose of tbo-filgrastim; (3) any acute illness within 1 week before the first dose of tbo-filgrastim; or (4) symptoms of any clinically relevant or acute illness at baseline
• The participant has existence or recent history of persistent pulmonary infiltrates, recent pneumonia, recent bronchitis, recurrent lung infections, or history or evidence of any lung disease including asthma, or current symptoms of upper respiratory tract infection. In the case of pneumonia, participant may be screened 12 weeks after cessation of antibiotic treatment
• The participant has findings of splenomegaly on sonography at screening, defined by length of spleen more than 12.3 centimeters (cm) and clinical judgment
• The participant has a history of malignancy, including hematologic malignancy, except for appropriately treated non-melanoma skin carcinoma in the last 5 years
• The participant has a clinically significant deviation from normal in ECG recordings or physical examination findings, as determined by the investigator
• The participant is pregnant or lactating, or was pregnant in the previous 6 months, or intends to get pregnant during the study or within 30 days after the last dose of study drug
• The participant has habitually consumed, within the last 2 years, more than 21 units of alcohol per week, or has a history or evidence of alcohol, narcotic, or any other substance abuse as defined by the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-V, American Psychiatric Association 2013). Note: A unit of alcohol is equal to 1 ounce (29.6 milliliters \[mL\]) of hard liquor, 5 ounces (148 mL) of wine, or 8 ounces (236.8 mL) of beer
• The participant has taken any of the following investigational medicinal products (IMPs), medicinal products, or substances:
• Any IMP within 30 days or 5 half-lives (whichever is longer) before the first dose of tbo-filgrastim, or in the case of a new chemical entity, 3 months or 5 half-lives (whichever is longer) before the first dose of tbo-filgrastim
• Known history of treatment with blood-cell colony-stimulating factors
• Current or recent (within 4 weeks) treatment with lithium
• The participant has donated plasma within 7 days before screening or has donated blood within 56 days before screening
• The participant has a documented or self-reported history of tuberculosis or recent travel to countries of endemic disease (last 8 weeks)
• The participant has 1 or more clinical laboratory test value(s) outside the range specified below, or any other clinically significant laboratory abnormality as determined by the investigator or medical monitor:

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (9)

Teva Investigational Site 14029

Duarte, California, 91010, United States

Location

Teva Investigational Site 14025

La Jolla, California, 92037-1027, United States

Location

Teva Investigational Site 14023

Beech Grove, Indiana, 46107, United States

Location

Teva Investigational Site 14026

Detroit, Michigan, 48201, United States

Location

Teva Investigational Site 14027

Chapel Hill, North Carolina, 27514, United States

Location

Teva Investigational Site 14030

Cincinnati, Ohio, 45242, United States

Location

Teva Investigational Site 14033

Greenville, South Carolina, 29615, United States

Location

Teva Investigational Site 14035

Memphis, Tennessee, 38120, United States

Location

Teva Investigational Site 14024

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

Filgrastim

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

The study was terminated early due to operational feasibility. The decision to terminate the study was not related to any new or emerging safety concerns.

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 23, 2017
• Study Start: August 2, 2017
• Primary Completion: October 30, 2017
• Study Completion: October 30, 2017
• Last Updated: December 13, 2022
• Results First Posted: December 14, 2018

Record last verified: 2022-12

Locations

US (9)