Immune Thrombocytopenia (ITP)Phase 1/2NCT02868060
Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)
A Phase 1/2 study testing Romiplostim in people with Immune Thrombocytopenia (ITP), run by Kyowa Kirin China Pharmaceutical Co., Ltd. at 5 sites in China.
Trial summary
The objective of evaluating the pharmacokinetics and pharmacodynamics of romiplostim in patients with immune thrombocytopenia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Immune Thrombocytopenia (ITP)
- What is being tested?
- Romiplostim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 5 sitesChina
- Study dates
- Sep 2015to Aug 2017
- Phase
- Phase 1/2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with immune thrombocytopenia (ITP) for at least 6 months prior to signing the informed consent form (ICF).
- Subject is ≥ 18 years old and ≤ 70 years old while signing the ICF.
- Patients who have no response or relapsed after splenectomy. Or patients who have not been splenectomised and have completed at least 1 prior treatment for ITP. Excluded having previously received recombinant human thrombopoietin (rHuTPO) or any other thrombopoietin receptor agonist.
- The mean of 3 scheduled platelet counts taken during the screening period must be: < 30 ×10^9/L, with none >35×10^9/L.
Who cannot join
- Any known history of bone marrow stem cell disorder. Any abnormal bone marrow findings other than typical of ITP.
- Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years prior to signing the ICF.
- Had received Eltrombopag, recombinant human thrombopoietin (rHuTPO) or other myeloproliferative leukemia (MPL) stimulation product.
- Received hematopoietic growth factors (e.g., granulocyte colony-stimulating factor, macrophage colony-stimulating factor, erythropoietin, interleukin-11) for any reason within 4 weeks prior to signing the ICF.
- Received any anti-malignancy agents (e.g., cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, interferon-alfa) for any reason within 8 weeks prior to signing the ICF.
- Received any monoclonal antibody drugs (e.g., rituximab) for any reason within 14 weeks prior to signing the ICF.
Show all 9Show fewer
- Less than 4 weeks since end of any clinical trials about therapeutic drug or device for any indication prior to signing the ICF.
- Pregnant or breast feeding.
- In the opinions of the principal investigator or investigators, the patients are not suitable for participation in this trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Peking Union hospital
Beijing
West China hospital
Chengdu
Chinese academy of medical science hematology hospital
Tianjin
Wuxi People's Hospital
Wuxi
Henan Cancer Hospital
Zhengzhou
About this study
The objective of evaluating the pharmacokinetics and pharmacodynamics of romiplostim in patients with immune thrombocytopenia.
- Conditions
- Immune Thrombocytopenia (ITP)
- Being tested
- Romiplostim
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomiplostimDrug
Also called AMG531
| Study group | Role | What they receive |
|---|---|---|
| 1 mcg/kg AMG531 | Experimental | The administration of Romiplostim will be performed on Day 1 and 8 Receives: Drug: Romiplostim |
| 3 mcg/kg AMG531 | Experimental | The administration of Romiplostim will be performed on Day 1 and 8 Receives: Drug: Romiplostim |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of all adverse events including evaluation of antidrug antibody status
Measured: Up to 43 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startSep 2015
- Primary completionAug 2017
- Study completionAug 2017
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 Immune Thrombocytopenia (ITP)Studies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin China Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chinese academy of medical science hematology hospital, Principal investigator, Chinese academy of medical science hematology hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868060
- Sponsor's protocol ID
- 531-CN001
- Status last verified
- Apr 2024
- First submitted
- 11 Aug 2016
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Qi J, Zheng L, Hu B, Zhou H, He Q, Liu H, Kawai H, Yang R. Pharmacokinetics, Safety, and Pharmacodynamics of Romiplostim in Chinese Subjects With Immune Thrombocytopenia: A Phase I/II Trial. Clin Pharmacol Drug Dev. 2022 Mar;11(3):379-387. doi: 10.1002/cpdd.1059. Epub 2021 Dec 17.
PubMed 34921514
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT02868060
- Acronym / sponsor ID
- 531-CN001
- Conditions
- Immune Thrombocytopenia (ITP)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kyowa Kirin China Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 16 Aug 2016 (estimated)
- 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.
The objective of evaluating the pharmacokinetics and pharmacodynamics of romiplostim in patients with immune thrombocytopenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 mcg/kg AMG531 | Experimental | Drug: RomiplostimThe administration of Romiplostim will be performed on Day 1 and 8 |
| 3 mcg/kg AMG531 | Experimental | Drug: RomiplostimThe administration of Romiplostim will be performed on Day 1 and 8 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with immune thrombocytopenia (ITP) for at least 6 months prior to signing the informed consent form (ICF).
- Subject is ≥ 18 years old and ≤ 70 years old while signing the ICF.
- Patients who have no response or relapsed after splenectomy. Or patients who have not been splenectomised and have completed at least 1 prior treatment for ITP. Excluded having previously received recombinant human thrombopoietin (rHuTPO) or any other thrombopoietin receptor agonist.
- The mean of 3 scheduled platelet counts taken during the screening period must be: < 30 ×10^9/L, with none >35×10^9/L.
Key exclusion criteria (9 listed)
- Any known history of bone marrow stem cell disorder. Any abnormal bone marrow findings other than typical of ITP.
- Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years prior to signing the ICF.
- Had received Eltrombopag, recombinant human thrombopoietin (rHuTPO) or other myeloproliferative leukemia (MPL) stimulation product.
- Received hematopoietic growth factors (e.g., granulocyte colony-stimulating factor, macrophage colony-stimulating factor, erythropoietin, interleukin-11) for any reason within 4 weeks prior to signing the ICF.
- Received any anti-malignancy agents (e.g., cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, interferon-alfa) for any reason within 8 weeks prior to signing the ICF.
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 |
|---|---|---|
| RomiplostimAlso: AMG531 | Drug | 1 mcg/kg AMG531, 3 mcg/kg AMG531 |
Primary outcome
The incidence of all adverse events including evaluation of antidrug antibody status
Time frame: Up to 43 days after dosing
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 29 Apr 2024.
- Derived from this study: PubMed 34921514Qi J, Zheng L, Hu B, Zhou H, He Q, Liu H, Kawai H, Yang R. Pharmacokinetics, Safety, and Pharmacodynamics of Romiplostim in Chinese Subjects With Immune Thrombocytopenia: A Phase I/II Trial. Clin Pharmacol Drug Dev. 2022 Mar;11(3):379-387. doi: 10.1002/cpdd.1059. Epub 2021 Dec 17.
- 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.
Chinese academy of medical science hematology hospital principal investigator
Chinese academy of medical science hematology hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Romiplostim in people with Immune Thrombocytopenia (ITP), run by Kyowa Kirin China Pharmaceutical Co., Ltd. at 5 sites 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 9 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 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The incidence of all adverse events including evaluation of antidrug antibody status (time frame: Up to 43 days after dosing). 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 NCT02868060, 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 29 Apr 2024.