Loading clinical trials...

KRN125 for Mobilization of Hematopoietic Stem Cells | Clinical Trials | Clareo Health

COMPLETEDPHASE2

KRN125 for Mobilization of Hematopoietic Stem Cells

A Phase II Clinical Trial of KRN125 to Mobilize Hematopoietic Stem Cells Into Peripheral Blood in Healthy Volunteers

NCT03993639•Kyowa Kirin Co., Ltd.

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.

Detailed Description

KRN125 is administered as a single SC dose to the Day 1. The stem cell mobilization protocols will be monitored for safety and efficacy during the mobilization period.

Eligibility

Age

20 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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

Exclusion Criteria

•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

Locations (1)

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Key Dates

Start Date

May 28, 2019

Primary Completion Date

July 21, 2020

Completion Date

August 28, 2020

Last Updated

January 22, 2021

Enrollment

ACTUAL participants

Conditions

Peripheral Blood Stem Cell Transplantation

Interventions

Pegfilgrastim

DRUG

The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation

NCT05436418

Peripheral Blood Stem Cell TransplantationHematopoietic Stem Cell Transplantation

View study

UNKNOWNPHASE1/PHASE2

Ruxolitinib and Chidamide for Acute T Cell Lymphoblast Leukemia/ Lymphoblastic Lymphoma

NCT05075681

Peripheral Blood Stem Cell Transplantation

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

KRN125 for Mobilization of Hematopoietic Stem Cells

Inclusion Criteria

Exclusion Criteria

The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation

Ruxolitinib and Chidamide for Acute T Cell Lymphoblast Leukemia/ Lymphoblastic Lymphoma

Ruxolitinib and Decitabine for High Risk Hematological Malignancies

Valproic Acid With Methylprenisonlone for the Treatment of Acute GVHD