Severe Aplastic AnemiaNCT05531279
A Study of PEG-rhG-CSF and rhG-CSF Used for Aplastic Anemia Granulocyte Deficiency
A study testing PEG-rhG-CSF in people with Severe Aplastic Anemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This study was a single-center,open-label,randomized,dose-exploring prospective study.Patients with granulocytotic aplastic anemia who received cytokine treatment with PEG-rhG-CSF or rhG-CSF were enrolled.Clinical demographic data,disease characteristics of aplastic anemia,clinical diagnosis and treatment,laboratory… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Severe Aplastic Anemia
- What is being tested?
- PEG-rhG-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2022to 5 Jan 2026
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old, male or female, or weight≥50kg.
- Patients with severe or very severe aplastic anemia of absolute neutrophil value< 0.5×109/L
- ECOG score ≤ 2 points.
- Normal renal function.
Who cannot join
- Patients with clonal chromosomal abnormalities.
- Patients with previous malignant tumors.
- Patients with severe or uncontrolled infectious diseases and /or bleeding.
- Patients with AIDS or syphilis positive.
- Severe organ dysfunction.
- Patients used GM/G-CSF,PEG-rhG-CSF,interleukin-11 within 2 weeks before admission.
- Allergic to G-CSF or PEG-rhG-CSF related components.
- Participated in other clinical trials within 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Fengkui Zhang, Doctor, 8602223909229, fkzhang@ihcams.ac.cn
Huihui Fan, Doctor, 8602223909223, fanhuihui@ihcams.ac.cn
About this study
Official title: A Randomized,Open-label Dose-discovery Study of PEG-rhG-CSF and rhG-CSF in the Adjuvant Therapy of Aplastic Anemia Granulocyte Deficiency
This study was a single-center,open-label,randomized,dose-exploring prospective study.Patients with granulocytotic aplastic anemia who received cytokine treatment with PEG-rhG-CSF or rhG-CSF were enrolled.Clinical demographic data,disease characteristics of aplastic anemia,clinical diagnosis and treatment,laboratory data and adverse events were collected to explore the dose and safety of PEG-rhG-CSF and rhG-CSF in patients with severe aplastic anemia.
Read the detailed description
This study was a single-center,open-label,randomized,dose-exploring prospective study.Patients with granulocytotic aplastic anemia who received cytokine treatment with PEG-rhG-CSF or rhG-CSF were enrolled.Clinical demographic data,disease characteristics of aplastic anemia,clinical diagnosis and treatment,laboratory data and adverse events were collected to explore the dose and safety of PEG-rhG-CSF and rhG-CSF in patients with severe aplastic anemia.Research objectives: To explore the reasonable injection frequency of long-acting PEG-rhG-CSF in the adjuvant treatment of aplastic anemia patients with granulocytosis through a single center prospective clinical study.Disease classification of aplastic anemia: a total of 45 cases of SAA/VSAA with ANC<0.5×109/L were stratified and randomized into three groups according to the radio of 1:1:1(15 cases in each group).PEG-rhG-CSF group A(q7d):6mg d1,8,subcutaneously injected;PEG-rhG-CSF group B(q10d):6mg d1,11,subcutaneously injected;RhG-CSF group(short-acting ): 480ug d1-14(daily for 14days),subcutaneously injected.Dose/protocol adjustment: after monitoring ANC>0.5×109/L,the drug was stopped,and then ANC<0.5×109/L was temporarily supplemented with one dose of the original group of drugs.
- Conditions
- Severe Aplastic Anemia
- Being tested
- PEG-rhG-CSF
- Keywords
- G-CSF
- Medical subject headings
- Anemia, Aplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-rhG-CSFDrug
Also called rhG-CSF
PEG-rhG-CSF group A(q7d):6mg d1,8,subcutaneously injected; PEG-rhG-CSF group B(q10d):6mg d1,11,subcutaneously injected; RhG-CSF group(short-acting ): 480ug d1-14(daily for 14days),subcutaneously injected.
| Study group | Role | What they receive |
|---|---|---|
| PEG-rhG-CSF group A | Experimental | PEG-rhG-CSF group A(q7d):6mg d1,8,subcutaneously injected,after monitoring ANC>0.5×109/L,the drug was stopped,and then ANC<0.5×109/L was temporarily supplemented with one dose of the same drug. Receives: Drug: PEG-rhG-CSF |
| PEG-rhG-CSF group B | Experimental | PEG-rhG-CSF group B(q10d):6mg d1,11,subcutaneously injected,after monitoring ANC>0.5×109/L,the drug was stopped,and then ANC<0.5×109/L was temporarily supplemented with one dose of the same drug. Receives: Drug: PEG-rhG-CSF |
| rhG-CSF group(short-acting ) | Experimental | rhG-CSF group(short-acting ): 480ug d1-14(daily for 14days),subcutaneously injected.After monitoring ANC>0.5×109/L,the drug was stopped,and then ANC<0.5×109/L was temporarily supplemented with one dose of the same drug. Receives: Drug: PEG-rhG-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
total number of effective (ANC>0.5×109/L) days
total number of effective (ANC>0.5×109/L) days during 2 weeks of treatment(cases×days).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start5 Jun 2022
- Primary completion5 Jun 2025 (estimated)
- Study completion5 Jan 2026 (estimated)
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 Severe Aplastic AnemiaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liping Jing, Doctor, Study director, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531279
- Sponsor's protocol ID
- IIT2021022-EC-1
- Status last verified
- Sep 2022
- First submitted
- 2 Sep 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We can share the plan after completing the experiment
Publications
Tichelli A, Schrezenmeier H, Socie G, Marsh J, Bacigalupo A, Duhrsen U, Franzke A, Hallek M, Thiel E, Wilhelm M, Hochsmann B, Barrois A, Champion K, Passweg JR. A randomized controlled study in patients with newly diagnosed severe aplastic anemia receiving antithymocyte globulin (ATG), cyclosporine, with or without G-CSF: a study of the SAA Working Party of the European Group for Blood and Marrow Transplantation. Blood. 2011 Apr 28;117(17):4434-41. doi: 10.1182/blood-2010-08-304071. Epub 2011 Jan 13.
PubMed 21233311
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized,Open-label Dose-discovery Study of PEG-rhG-CSF and rhG-CSF in the Adjuvant Therapy of Aplastic Anemia Granulocyte Deficiency
- ClinicalTrials.gov ID
- NCT05531279
- Acronym / sponsor ID
- IIT2021022-EC-1
- Conditions
- Severe Aplastic Anemia
- Keywords
- G-CSF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 5 Jun 2025 (estimated)
- Study completion
- 5 Jan 2026 (estimated)
- First posted
- 7 Sep 2022 (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.
This study was a single-center,open-label,randomized,dose-exploring prospective study.Patients with granulocytotic aplastic anemia who received cytokine treatment with PEG-rhG-CSF or rhG-CSF were enrolled.Clinical demographic data,disease characteristics of aplastic anemia,clinical diagnosis and treatment,laboratory data and adverse events were collected to explore the dose and safety of PEG-rhG-CSF and rhG-CSF in patients with severe aplastic anemia.
Detailed description
This study was a single-center,open-label,randomized,dose-exploring prospective study.Patients with granulocytotic aplastic anemia who received cytokine treatment with PEG-rhG-CSF or rhG-CSF were enrolled.Clinical demographic data,disease characteristics of aplastic anemia,clinical diagnosis and treatment,laboratory data and adverse events were collected to explore the dose and safety of PEG-rhG-CSF and rhG-CSF in patients with severe aplastic anemia.Research objectives: To explore the reasonable injection frequency of long-acting PEG-rhG-CSF in the adjuvant treatment of aplastic anemia patients with granulocytosis through a single center prospective clinical study.Disease classification of aplastic anemia: a total of 45 cases of SAA/VSAA with ANC<0.5×109/L were stratified and randomized into three groups according to the radio of 1:1:1(15 cases in each group).PEG-rhG-CSF group A(q7d):6mg d1,8,subcutaneously injected;PEG-rhG-CSF group B(q10d):6mg d1,11,subcutaneously injected;RhG-CSF group(short-acting ): 480ug d1-14(daily for 14days),subcutaneously injected.Dose/protocol adjustment: after monitoring ANC>0.5×109/L,the drug was stopped,and then ANC<0.5×109/L was temporarily supplemented with one dose of the original group of drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEG-rhG-CSF group A | Experimental | Drug: PEG-rhG-CSFPEG-rhG-CSF group A(q7d):6mg d1,8,subcutaneously injected,after monitoring ANC>0.5×109/L,the drug was stopped,and then ANC<0.5×109/L was temporarily supplemented with one dose of the same drug. |
| PEG-rhG-CSF group B | Experimental | Drug: PEG-rhG-CSFPEG-rhG-CSF group B(q10d):6mg d1,11,subcutaneously injected,after monitoring ANC>0.5×109/L,the drug was stopped,and then ANC<0.5×109/L was temporarily supplemented with one dose of the same drug. |
| rhG-CSF group(short-acting ) | Experimental | Drug: PEG-rhG-CSFrhG-CSF group(short-acting ): 480ug d1-14(daily for 14days),subcutaneously injected.After monitoring ANC>0.5×109/L,the drug was stopped,and then ANC<0.5×109/L was temporarily supplemented with one dose of the same drug. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70 years old, male or female, or weight≥50kg.
- Patients with severe or very severe aplastic anemia of absolute neutrophil value< 0.5×109/L
- ECOG score ≤ 2 points.
- Normal renal function.
Key exclusion criteria (8 listed)
- Patients with clonal chromosomal abnormalities.
- Patients with previous malignant tumors.
- Patients with severe or uncontrolled infectious diseases and /or bleeding.
- Patients with AIDS or syphilis positive.
- Severe organ dysfunction.
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 |
|---|---|---|
| PEG-rhG-CSFAlso: rhG-CSFPEG-rhG-CSF group A(q7d):6mg d1,8,subcutaneously injected; PEG-rhG-CSF group B(q10d):6mg d1,11,subcutaneously injected; RhG-CSF group(short-acting ): 480ug d1-14(daily for 14days),subcutaneously injected. | Drug | PEG-rhG-CSF group A, PEG-rhG-CSF group B, rhG-CSF group(short-acting ) |
Primary outcome
total number of effective (ANC>0.5×109/L) days
Time frame: 2 weeks
total number of effective (ANC>0.5×109/L) days during 2 weeks of treatment(cases×days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Results publication: PubMed 21233311Tichelli A, Schrezenmeier H, Socie G, Marsh J, Bacigalupo A, Duhrsen U, Franzke A, Hallek M, Thiel E, Wilhelm M, Hochsmann B, Barrois A, Champion K, Passweg JR. A randomized controlled study in patients with newly diagnosed severe aplastic anemia receiving antithymocyte globulin (ATG), cyclosporine, with or without G-CSF: a study of the SAA Working Party of the European Group for Blood and Marrow Transplantation. Blood. 2011 Apr 28;117(17):4434-41. doi: 10.1182/blood-2010-08-304071. Epub 2011 Jan 13.
- Individual participant dataSharing planned: Yes. We can share the plan after completing the experiment
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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.
Liping Jing, Doctor study director
Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG-rhG-CSF in people with Severe Aplastic Anemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Sep 2022. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fengkui Zhang, Doctor (+862223909229, fkzhang@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total number of effective (ANC>0.5×109/L) days (time frame: 2 weeks). 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 NCT05531279, 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 26 Sep 2022.