Peripheral Blood Stem Cell TransplantationPhase 2NCT03993639
KRN125 for Mobilization of Hematopoietic Stem Cells
A Phase 2 study testing Pegfilgrastim in people with Peripheral Blood Stem Cell Transplantation, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Blood Stem Cell Transplantation
- What is being tested?
- Pegfilgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteJapan
- Study dates
- 28 May 2019to 28 Aug 2020
- Phase
- Phase 2
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Clinical Trial of KRN125 to Mobilize Hematopoietic Stem Cells Into Peripheral Blood in Healthy Volunteers
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.
Read the 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.
- Being tested
- Pegfilgrastim
- Keywords
- Hematopoietic Stem Cells Mobilization, Healthy Volunteer (HV), filgrastim, allogenic hematopoetic stem cell transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegfilgrastimDrug
Single dose of SC administration
| Study group | Role | What they receive |
|---|---|---|
| KRN125 | Experimental | Single SC administration Receives: Drug: Pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of >20 cells/μL positive for CD34 in peripheral blood from baseline to Day 7
Measured: Baseline to Day 7
Secondary outcomes (6)
• Period from baseline to first time peripheral blood CD34 positive cells >20 cells/μL
Measured: Baseline to Day 15 or through study completion, an average of 1 year
• Time from baseline to peak peripheral blood CD34 positive cells
Measured: 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
Measured: Baseline to Day 7
• Peripheral blood CD34 positive cell count
Measured: Baseline to Day 15 or through study completion, an average of 1 year
• Peripheral blood white blood cell count
Measured: Baseline to Day 15 or through study completion, an average of 1 year
• Peripheral blood neutrophil count
Measured: Baseline to Day 15 or through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start28 May 2019
- Primary completion21 Jul 2020
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Blood Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase II, single center, open label, non-control, dose setting study
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993639
- Sponsor's protocol ID
- 125-101
- Status last verified
- Jan 2021
- First submitted
- 23 May 2019
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38012835
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial of KRN125 to Mobilize Hematopoietic Stem Cells Into Peripheral Blood in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03993639
- Acronym / sponsor ID
- 125-101
- Keywords
- Hematopoietic Stem Cells Mobilization, Healthy Volunteer (HV), filgrastim, allogenic hematopoetic stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 May 2019 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase II, single center, open label, non-control, dose setting study
| Arm | Type | Receives |
|---|---|---|
| KRN125 | Experimental | Drug: PegfilgrastimSingle SC administration |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PegfilgrastimSingle dose of SC administration | Drug | KRN125 |
Primary outcome
Achievement of >20 cells/μL positive for CD34 in peripheral blood from baseline to Day 7
Time frame: Baseline to Day 7
6 secondary outcomes
• Period from baseline to first time peripheral blood CD34 positive cells >20 cells/μL
Time frame: Baseline to Day 15 or through study completion, an average of 1 year
• Time from baseline to peak peripheral blood CD34 positive cells
Time frame: 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
Time frame: Baseline to Day 7
• Peripheral blood CD34 positive cell count
Time frame: Baseline to Day 15 or through study completion, an average of 1 year
• Peripheral blood white blood cell count
Time frame: Baseline to Day 15 or through study completion, an average of 1 year
• Peripheral blood neutrophil count
Time frame: Baseline to Day 15 or through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Derived from this study: PubMed 38012835Goto 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegfilgrastim in people with Peripheral Blood Stem Cell Transplantation, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
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 2 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Achievement of >20 cells/μL positive for CD34 in peripheral blood from baseline to Day 7 (time frame: Baseline to Day 7). 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 NCT03993639, 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 22 Jan 2021.