Purpura, Thrombocytopenic, IdiopathicIncritopNCT01317966
Recombinant Human Interleukin-11 Combination Low-dose Rituximab in Immune Thrombocytopenia
An observational study of Purpura, Thrombocytopenic, Idiopathic, run by Ming Hou at 1 site in China.
Trial summary
The purpose of this study is to determine whether Recombinant Human Interleukin-11 (rhIL-11) Combination Low-dose Rituximab prednisone are effective and safe in the management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP). Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Purpura, Thrombocytopenic, Idiopathic
- What is being tested?
- rhIL-11
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to Mar 2012
- Phase
- Observational
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 100
Who may be able to join
- Patients may be male or female, between the ages of 16 ~ 75 years old.
- Isolated thrombocytopenia with an otherwise normal peripheral blood smear and no other causes of thrombocytopenia, morphologically normal bone marrow aspirate with normal to increased number of megakaryocytes, and absence of splenomegaly.
- To show a platelet count ≤ 30 × 109/L, or platelet count ≥ 30 × 109/L with bleeding manifestations at the moment of the first infusion with the study product.
- ＥＣＯＧ performance status ≤ 2.
- Patients failed to respond to acceptable dose of steroids for 4 weeks, or relapsed. Some patients were also refractory to splenectomy.
- Patients must be willing and able to give written informed consent.
Who cannot join
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
- Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
- Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
- Current HIV infection or hepatitis B virus or hepatitis C virus infections.
- Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia).
- Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
- Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
- Patients who are deemed unsuitable for the study by the investigator (or coinvestigator).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre Investigation of Recombinant Human Interleukin-11 (rhIL-11) Combination Low-dose Rituximab in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP)
The purpose of this study is to determine whether Recombinant Human Interleukin-11 (rhIL-11) Combination Low-dose Rituximab prednisone are effective and safe in the management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).
- Conditions
- Purpura, Thrombocytopenic, Idiopathic
- Being tested
- rhIL-11
- 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.
rhIL-11Drug
Also called Rituximab, ITP
Recombinant Human Interleukin-11 (rhIL-11) Combinating Low-dose Rituximab
| Study group | Role | What they receive |
|---|---|---|
| rhIL-11Combinating Low-dose Rituximab | rhIL-11 (interleukin-11, Juheli) 50 mcg/kg subcutaneously daily for 14 days
Rituximab 100mcg weekly for 4 weeks Receives: Drug: rhIL-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of platelet response (Complete Response)
CR. A complete response (CR) was defined as a sustained (≥ 4 months) platelet count ≥ 100×109/L without recurrence of thrombocytopenia
Measured: The time frame is up to 14 days per subject
Secondary outcomes (4)
Evaluation of platelet response (R)
- A response (R) was defined as a sustained (≥ 4 months) platelet count ≥ 30×109/L without recurrence of thrombocytopenia
Measured: The time frame is up to 14 days per subject
The time of rhIL-11 onset.
The time to platelet recovery (defined as the number of days from the start of the study to the first day with a platelet count of ≥30 × 109/L)
Measured: The time frame is up to 28 days per subject.
DFS
The median disease-free survival periods
Measured: The time frame is up to 90 days per subject.
The number and frequency of IL-11 associated adverse events.
Measured: up to 14 days per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011 (estimated)
- Study completionMar 2012 (estimated)
Why it stopped: No eligible patients were enrolled.
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 Purpura, Thrombocytopenic, IdiopathicStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ming Hou
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, First Affiliated Hospital, Sun Yat-Sen University, West China Hospital, Shandong Provincial Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Zhejiang University
- Responsible party
- Sponsor-investigator, Ming Hou, Shandong University
- Investigators
- Ming Hou, Dr., Principal investigator, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317966
- Sponsor's protocol ID
- ITP-001
- Acronym
- Incritop
- Status last verified
- Nov 2011
- First submitted
- 17 Mar 2011
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Zaja F, Vianelli N, Volpetti S, Battista ML, Defina M, Palmieri S, Bocchia M, Medeot M, De Luca S, Ferrara F, Isola M, Baccarani M, Fanin R. Low-dose rituximab in adult patients with primary immune thrombocytopenia. Eur J Haematol. 2010 Oct;85(4):329-34. doi: 10.1111/j.1600-0609.2010.01486.x. Epub 2010 Jul 28.
PubMed 20546023
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Investigation of Recombinant Human Interleukin-11 (rhIL-11) Combination Low-dose Rituximab in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT01317966
- Acronym / sponsor ID
- Incritop / ITP-001
- Conditions
- Purpura, Thrombocytopenic, Idiopathic
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No eligible patients were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ming HouUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, First Affiliated Hospital, Sun Yat-Sen University, West China Hospital, Shandong Provincial Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Zhejiang University
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 18 Mar 2011 (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 purpose of this study is to determine whether Recombinant Human Interleukin-11 (rhIL-11) Combination Low-dose Rituximab prednisone are effective and safe in the management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rhIL-11Combinating Low-dose Rituximab | – | Drug: rhIL-11rhIL-11 (interleukin-11, Juheli) 50 mcg/kg subcutaneously daily for 14 days Rituximab 100mcg weekly for 4 weeks |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 100
Key inclusion criteria (6 listed)
- Patients may be male or female, between the ages of 16 ~ 75 years old.
- Isolated thrombocytopenia with an otherwise normal peripheral blood smear and no other causes of thrombocytopenia, morphologically normal bone marrow aspirate with normal to increased number of megakaryocytes, and absence of splenomegaly.
- To show a platelet count ≤ 30 × 109/L, or platelet count ≥ 30 × 109/L with bleeding manifestations at the moment of the first infusion with the study product.
- ＥＣＯＧ performance status ≤ 2.
- Patients failed to respond to acceptable dose of steroids for 4 weeks, or relapsed. Some patients were also refractory to splenectomy.
Key exclusion criteria (8 listed)
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
- Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
- Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
- Current HIV infection or hepatitis B virus or hepatitis C virus infections.
- Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia).
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 |
|---|---|---|
| rhIL-11Also: Rituximab, ITPRecombinant Human Interleukin-11 (rhIL-11) Combinating Low-dose Rituximab | Drug | rhIL-11Combinating Low-dose Rituximab |
Primary outcome
Evaluation of platelet response (Complete Response)
Time frame: The time frame is up to 14 days per subject
CR. A complete response (CR) was defined as a sustained (≥ 4 months) platelet count ≥ 100×109/L without recurrence of thrombocytopenia
4 secondary outcomes
Evaluation of platelet response (R)
Time frame: The time frame is up to 14 days per subject
The time of rhIL-11 onset.
Time frame: The time frame is up to 28 days per subject.
DFS
Time frame: The time frame is up to 90 days per subject.
The number and frequency of IL-11 associated adverse events.
Time frame: up to 14 days per subject
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
- Results publication: PubMed 20546023Zaja F, Vianelli N, Volpetti S, Battista ML, Defina M, Palmieri S, Bocchia M, Medeot M, De Luca S, Ferrara F, Isola M, Baccarani M, Fanin R. Low-dose rituximab in adult patients with primary immune thrombocytopenia. Eur J Haematol. 2010 Oct;85(4):329-34. doi: 10.1111/j.1600-0609.2010.01486.x. Epub 2010 Jul 28.
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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.
Ming Hou, Dr. principal investigator
Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Purpura, Thrombocytopenic, Idiopathic, run by Ming Hou 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 6 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: withdrawn, as of the sponsor's last update on 20 Apr 2016. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluation of platelet response (Complete Response) (time frame: The time frame is up to 14 days per subject). 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 NCT01317966, 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 20 Apr 2016.