Immune Thrombocytopenic PurpuraITPNCT01672151
Efficacy of Rapamycin Therapy With Chronic Immune Thrombocytopenia
An observational study of Immune Thrombocytopenic Purpura, run by First Affiliated Hospital of Suzhou Medical College at 1 site in China.
Trial summary
The aim of our study is to evaluate the efficacy of rapamycin with Refractory Immune Thrombocytopenic Purpura (RITP) and explore the further mechanism. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Immune Thrombocytopenic Purpura
- What is being tested?
- rapamycin
- Type of treatment
- Pill or oral medicine
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Aug 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 35 patients using rapamycin therapy were observed before and after treatment,who did not response to any other administrations including prednisone and immunosuppressive drugs, even splenectomy .
Who may be able to join
- Clinical diagnoses of idiopathic thrombocytopenic purpura
- Hormone and immune suppression, splenectomy is invalid
Who cannot join
- patients had a bad tolerance to rapamycin
- platelet counts < 10*10E9/L during the treatment of rapamycin
Trial locations and contacts
1 site in 1 country.
About this study
The aim of our study is to evaluate the efficacy of rapamycin with Refractory Immune Thrombocytopenic Purpura (RITP) and explore the further mechanism.
Read the detailed description
Rapamycin, an immunosuppressive drug, is widely used to prevent allograft rejection and autoimmune diseases. Many studies have shown that the drug contributes to the expansion of regulatory T cells and preserves the highly suppressive function of autoreactive T cells. Patients with RITP often display a decreased proportion of regulatory T cells by flow cytometer, therefore, the investigators will examine the efficacy of rapamycin in RITP patients.
- Conditions
- Immune Thrombocytopenic Purpura
- Being tested
- rapamycin
- Keywords
- Refractory Immune Thrombocytopenic Purpura, rapamycin, regulatory T cells
- 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.
rapamycinDrug
Also called sirolimus
4mg oral administration on the first day, 2 mg/d oral administration for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startNov 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenic PurpuraStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Suzhou Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoyue Wang, First Affiliated Hospital of Suzhou Medical College
- Investigators
- zhaoyue wang, doctor, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672151
- Sponsor's protocol ID
- jsxys456
- Acronym
- ITP
- Status last verified
- Aug 2012
- First submitted
- 17 Aug 2012
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rapamycin Therapy With Chronic Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT01672151
- Acronym / sponsor ID
- ITP / jsxys456
- Conditions
- Immune Thrombocytopenic Purpura
- Keywords
- Refractory Immune Thrombocytopenic Purpura, rapamycin, regulatory T cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Suzhou Medical CollegeUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 24 Aug 2012 (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 aim of our study is to evaluate the efficacy of rapamycin with Refractory Immune Thrombocytopenic Purpura (RITP) and explore the further mechanism.
Detailed description
Rapamycin, an immunosuppressive drug, is widely used to prevent allograft rejection and autoimmune diseases. Many studies have shown that the drug contributes to the expansion of regulatory T cells and preserves the highly suppressive function of autoreactive T cells. Patients with RITP often display a decreased proportion of regulatory T cells by flow cytometer, therefore, the investigators will examine the efficacy of rapamycin in RITP patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 35 patients using rapamycin therapy were observed before and after treatment,who did not response to any other administrations including prednisone and immunosuppressive drugs, even splenectomy .
Key inclusion criteria (2 listed)
- Clinical diagnoses of idiopathic thrombocytopenic purpura
- Hormone and immune suppression, splenectomy is invalid
Key exclusion criteria (2 listed)
- patients had a bad tolerance to rapamycin
- platelet counts < 10*10E9/L during the treatment of rapamycin
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 |
|---|---|---|
| rapamycinAlso: sirolimus4mg oral administration on the first day, 2 mg/d oral administration for 3 months | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Aug 2012.
Related trials for Immune Thrombocytopenic Purpura
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
RecruitingPhase 3
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
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.
zhaoyue wang, doctor study director
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 Immune Thrombocytopenic Purpura, run by First Affiliated Hospital of Suzhou Medical College 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 2 inclusion and 2 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 24 Aug 2012. 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 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.
Where can I read the original study information?
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 24 Aug 2012.