NCT03993639

Brief Summary

Data collection to evaluate safety and effect of hematopoietic stem cell mobilization into the peripheral blood after a single subcutaneous (SC) dose of KRN125(Pegfilgrastim)in healthy adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

May 28, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2020

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

May 23, 2019

Last Update Submit

January 20, 2021

Conditions

Peripheral Blood Stem Cell Transplantation

Keywords

Hematopoietic Stem Cells MobilizationHealthy Volunteer (HV)filgrastimallogenic hematopoetic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • Achievement of >20 cells/μL positive for CD34 in peripheral blood from baseline to Day 7

    Baseline to Day 7

Secondary Outcomes (6)

  • • Period from baseline to first time peripheral blood CD34 positive cells >20 cells/μL

    Baseline to Day 15 or through study completion, an average of 1 year

  • • Time from baseline to peak peripheral blood CD34 positive cells

    Baseline to Day 15 or through study completion, an average of 1 year

  • • Achievement of >10 cells/μL positive for CD34 in peripheral blood from baseline to Day 7

    Baseline to Day 7

  • • Peripheral blood CD34 positive cell count

    Baseline to Day 15 or through study completion, an average of 1 year

  • • Peripheral blood white blood cell count

    Baseline to Day 15 or through study completion, an average of 1 year

  • +1 more secondary outcomes

Study Arms (1)

KRN125

EXPERIMENTAL

Single SC administration

Drug: Pegfilgrastim

Interventions

PegfilgrastimDRUG

Single dose of SC administration

KRN125

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Japanese subjects aged 20 to 55 years or younger at the submission of the written informed consent form
  • Women weighing 40 kg or more and 80 kg or less and men weighing 45 kg or more and 80 kg or less at the time of the preliminary examination

You may not qualify if:

  • Subjects with a current medical history or who have been judged to be inappropriate for the study (e.g., significant neurological, hepatic, renal, endocrine, cardiovascular, blood, gastrointestinal, respiratory, and metabolic diseases, malignancies, myeloproliferative disorder, or psychiatric disorders)
  • Individuals with alcohol or drug dependence, or individuals who have not tested negative for all drugs of abuse in the preliminary test
  • Subjects with a history or current history of drug allergy or symptomatic allergy
  • Active infection or history of recurrent infection- However, only patients who are HBsantibody-positive by hepatitis B vaccination and whose HBV-DNA is less than the lower limit of quantitation will be allowed to participate in this study.
  • Subjects who used drugs within 2 weeks before administration of the investigational drug.
  • Subjects who have had at least 200 mL of blood drawn within 3 months before administration of the investigational drug.
  • Pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Location

Related Publications (1)

  • Goto H, Sugita J, Hasegawa Y, Hayasaka K, Sunagoya K, Hatase R, Nishida M, Ichihashi Y, Odera M, Senjo H, Yokoyama S, Ara T, Shiratori S, Endo T, Hino M, Maeda Y, Sawa M, Sato N, Teshima T. Efficacy and Safety of Single-dose Pegfilgrastim for CD34 + Cell Mobilization in Healthy Volunteers: A Phase 2 Study. Transplantation. 2024 Apr 1;108(4):996-1003. doi: 10.1097/TP.0000000000004880. Epub 2024 Mar 23.

    PMID: 38012835DERIVED

MeSH Terms

Interventions

pegfilgrastim

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Phase II, single center, open label, non-control, dose setting study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2019

First Posted

June 21, 2019

Study Start

May 28, 2019

Primary Completion

July 21, 2020

Study Completion

August 28, 2020

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations

JP(1)