Immune Thrombocytopenic PurpuraITPNCT01668615
Efficacy of Immunomudulatory Therapy With All-trans Retinoid Acid for Adults 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 purpose of this study is to determine whether All-trans retinoic acid (ATRA) are effective in the treatment of refractory idiopathic thrombocytopenic purpura (RITP). 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?
- all-trans-retinoid acid
- Type of treatment
- Pill or oral medicine
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- Jan 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 of RITP who do not response to prednisone,immunosuppressive agents and/or splenectomy were observed in our study .
Who may be able to join
- Clinical diagnosis of refratory idiopathic thrombocytopenic purpura
- Hormone and immune suppression, splenectomy is invalid
Who cannot join
- Other autoimmune diseases
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether All-trans retinoic acid (ATRA) are effective in the treatment of refractory idiopathic thrombocytopenic purpura (RITP).
Read the detailed description
Idiopathic thrombocytopenic purpura(ITP), an acquired immune disease is characterized by impaired generation of autoantibody-specific platelet. At least 30% adult patients turn into refractory ITP. The pathogenesis of ITP remains to be elucidated. Now ,CD4+ helper cells have been classified as belong to T-helper 1(TH1), T-helper 2(TH2), T-helper17and Regulory T cell(Tregs). All-trans retinoic acid(ATRA) mainly applied in skin disease and acute promyelocytic leukemia. Recently, ATRA is also a immunomodulator which can induce differentiation, proliferation, apoptosis of cells, and immunomudulatory. In the international, the investigators first treat RITP with ATRA. To investigate the therapeutic effects of ATRA on RITP, and using new index in the cells, cytokines and molecular biology of three in-depth study of its mechanism.
- Conditions
- Immune Thrombocytopenic Purpura
- Being tested
- all-trans-retinoid acid
- Keywords
- idiopathicthrombocytopenic purpura, all-trans retinoic acid, regulory 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.
all-trans-retinoid acidDrug
Also called Tretinoin
10 mg three times a day oral administration for 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startJan 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
- NCT01668615
- Sponsor's protocol ID
- jsxys-123
- Acronym
- ITP
- Status last verified
- Oct 2012
- First submitted
- 30 Jul 2012
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Immunomudulatory Therapy With All-trans Retinoid Acid for Adults With Chronic Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT01668615
- Acronym / sponsor ID
- ITP / jsxys-123
- Conditions
- Immune Thrombocytopenic Purpura
- Keywords
- idiopathicthrombocytopenic purpura, all-trans retinoic acid, regulory 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
- Jan 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 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 purpose of this study is to determine whether All-trans retinoic acid (ATRA) are effective in the treatment of refractory idiopathic thrombocytopenic purpura (RITP).
Detailed description
Idiopathic thrombocytopenic purpura(ITP), an acquired immune disease is characterized by impaired generation of autoantibody-specific platelet. At least 30% adult patients turn into refractory ITP. The pathogenesis of ITP remains to be elucidated. Now ,CD4+ helper cells have been classified as belong to T-helper 1(TH1), T-helper 2(TH2), T-helper17and Regulory T cell(Tregs). All-trans retinoic acid(ATRA) mainly applied in skin disease and acute promyelocytic leukemia. Recently, ATRA is also a immunomodulator which can induce differentiation, proliferation, apoptosis of cells, and immunomudulatory. In the international, the investigators first treat RITP with ATRA. To investigate the therapeutic effects of ATRA on RITP, and using new index in the cells, cytokines and molecular biology of three in-depth study of its mechanism.
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 of RITP who do not response to prednisone,immunosuppressive agents and/or splenectomy were observed in our study .
Key inclusion criteria (2 listed)
- Clinical diagnosis of refratory idiopathic thrombocytopenic purpura
- Hormone and immune suppression, splenectomy is invalid
Key exclusion criteria (1 listed)
- Other autoimmune diseases
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 |
|---|---|---|
| all-trans-retinoid acidAlso: Tretinoin10 mg three times a day oral administration for 4 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 23 Oct 2012.
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RecruitingPhase 3
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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.
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 1 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 23 Oct 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 23 Oct 2012.