Immune ThrombocytopeniaPhase 2/3NCT03692754
Atorvastatin in Management of Newly Diagnosed ITP
A Phase 2/3 study testing Atorvastatin 20mg, Atorvastatin 10mg and Dexamethasone in people with Immune Thrombocytopenia and Purpura, Thrombocytopenic, run by Shandong University at 1 site in China.
Trial summary
The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of atorvastatin for the treatment of adults with immune thrombocytopenia (ITP). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immune Thrombocytopenia, Purpura, Thrombocytopenic
- What is being tested?
- Atorvastatin 20mg, Atorvastatin 10mg and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 1 Dec 2023
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria for immune thrombocytopenia.
- within 3 months from diagnosis,untreated patients, may be male orfemale, between the ages of 18 ~ 80 years.
- To show a platelet count > 30×10^9/L and without bleeding manifestations.
Who cannot join
- Received chemotherapy or anticoagulants or other drugs affecting theplatelet counts within 3 months before the screening visit.
- Received steroids or other effective therapy for immune thrombocytopenia.
- Current HIV infection or hepatitis B virus or hepatitis C virus infections.
- Severe medical condition (lung, hepatic or renal disorder) other than 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Qilu hospital, Shandong University
Jinan, Shandong, 250012
Ming Hou, houming@medmail.com.cn
Ming Hou
About this study
Official title: A Single-center Prospective Randomized Study of Atorvastatin in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)
The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of atorvastatin for the treatment of adults with immune thrombocytopenia (ITP).
Read the detailed description
The investigators anticipate to undertaking a parallel group, single-centre, randomised controlled trial of 30 ITP adult patients, which have no indications of glucocorticoid therapy (platelets count > 30*10^9/L )from Qilu Hospital of Shandong University in China.15 of the participants are randomly selected to receive atorvastatin in 20 mg/d combining with 10 mg/d for 6 months. Platelet count, bleeding and other symptoms were evaluated before and after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of atorvastatin for the treatment of adults with ITP.
- Conditions
- Immune Thrombocytopenia, Purpura, Thrombocytopenic
- Being tested
- Atorvastatin 20mg, Atorvastatin 10mg, Dexamethasone
- Keywords
- Immune Thrombocytopenia
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Purpura, Thrombocytopenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 20mgDrug
Also called atorvastatin calcium
Atorvastatin will be given in 20 mg po qn for 1 month
Atorvastatin 10mgDrug
Also called atorvastatin calcium
Atorvastatin will be given in 10 mg po qn for 1 month
DexamethasoneDrug
Dexamethasone will be given in 40mg po qd for 4 days
| Study group | Role | What they receive |
|---|---|---|
| AT with 10 mg/d | Active comparator | The patients will be given receive atorvastatin in 10 mg/d for 1 month plus dexamethasone 40mg/d for 4 days. Receives: Drug: Atorvastatin 10mg; Drug: Dexamethasone |
| AT with 20 mg/d | Active comparator | The patients will be given atorvastatin in 20 mg/d for 1 month plus dexamethasone 40mg/d for 4 days. Receives: Drug: Atorvastatin 20mg; Drug: Dexamethasone |
| Dexamethasone | Experimental | The patients will be given dexamethasone 40mg/d for 4 days. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of platelet response
Platelet count will be observed at 1 month, 3 months, 6 months and 12 months after atorvastatin therapy
Measured: up to 1 year per subject
Secondary outcomes (1)
Therapy associated adverse events
The number and frequency of therapy associated adverse events
Measured: up to 1 year per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 Nov 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Hou, Shandong University
- Investigators
- Ming Hou, Dr, Principal investigator, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692754
- Sponsor's protocol ID
- Atorvastatin in ITP
- Status last verified
- Aug 2021
- First submitted
- 29 Sep 2018
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Prospective Randomized Study of Atorvastatin in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT03692754
- Acronym / sponsor ID
- Atorvastatin in ITP
- Conditions
- Immune Thrombocytopenia, Purpura, Thrombocytopenic
- Keywords
- Immune Thrombocytopenia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 2 Oct 2018 (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.
The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of atorvastatin for the treatment of adults with immune thrombocytopenia (ITP).
Detailed description
The investigators anticipate to undertaking a parallel group, single-centre, randomised controlled trial of 30 ITP adult patients, which have no indications of glucocorticoid therapy (platelets count > 30*10^9/L )from Qilu Hospital of Shandong University in China.15 of the participants are randomly selected to receive atorvastatin in 20 mg/d combining with 10 mg/d for 6 months. Platelet count, bleeding and other symptoms were evaluated before and after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of atorvastatin for the treatment of adults with ITP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AT with 10 mg/d | Active comparator | Drug: Atorvastatin 10mg, Drug: DexamethasoneThe patients will be given receive atorvastatin in 10 mg/d for 1 month plus dexamethasone 40mg/d for 4 days. |
| AT with 20 mg/d | Active comparator | Drug: Atorvastatin 20mg, Drug: DexamethasoneThe patients will be given atorvastatin in 20 mg/d for 1 month plus dexamethasone 40mg/d for 4 days. |
| Dexamethasone | Experimental | Drug: DexamethasoneThe patients will be given dexamethasone 40mg/d for 4 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meet the diagnostic criteria for immune thrombocytopenia.
- within 3 months from diagnosis,untreated patients, may be male orfemale, between the ages of 18 ~ 80 years.
- To show a platelet count > 30×10^9/L and without bleeding manifestations.
Key exclusion criteria (8 listed)
- Received chemotherapy or anticoagulants or other drugs affecting theplatelet counts within 3 months before the screening visit.
- Received steroids or other effective therapy for immune thrombocytopenia.
- Current HIV infection or hepatitis B virus or hepatitis C virus infections.
- Severe medical condition (lung, hepatic or renal disorder) other than 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 |
|---|---|---|
| Atorvastatin 20mgAlso: atorvastatin calciumAtorvastatin will be given in 20 mg po qn for 1 month | Drug | AT with 20 mg/d |
| Atorvastatin 10mgAlso: atorvastatin calciumAtorvastatin will be given in 10 mg po qn for 1 month | Drug | AT with 10 mg/d |
| DexamethasoneDexamethasone will be given in 40mg po qd for 4 days | Drug | AT with 10 mg/d, AT with 20 mg/d, Dexamethasone |
Primary outcome
Evaluation of platelet response
Time frame: up to 1 year per subject
Platelet count will be observed at 1 month, 3 months, 6 months and 12 months after atorvastatin therapy
1 secondary outcome
Therapy associated adverse events
Time frame: up to 1 year per subject
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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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?
A Phase 2/3 study testing Atorvastatin 20mg, Atorvastatin 10mg and Dexamethasone in people with Immune Thrombocytopenia and Purpura, Thrombocytopenic, run by Shandong University 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 3 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 5 Sep 2021. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ming Hou, Dr (+86-531-82169114 ext. 9879, houming@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of platelet response (time frame: up to 1 year per subject). It is what the study was designed to measure, not a finding.
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 5 Sep 2021.