Immune ThrombocytopeniaPhase 3NCT02351622
Caffeic Acid Tablets as a Second-line Therapy for ITP
A Phase 3 study testing Caffeic acid and Dexamethasone in people with Immune Thrombocytopenia, run by Shandong University at 1 site in China.
Trial summary
The investigators are undertaking a multicentre, randomised controlled trial of 120 adults with newly diagnosed ITP from 5 medical centers in China. Part of the participants are randomly selected to receive caffeic acid tablets combining dexamethasone and the other part are selected to receive high-dose dexamethasone… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- Caffeic acid and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Dec 2013
- Phase
- Phase 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
- Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80 years
- To show a platelet count <30 * 10^9/L, and with bleeding manifestations
- Willing and able to sign 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre Randomized Study of Caffeic Acid Tablets as a Second-line Therapy for the Treatment of Immune Thrombocytopenia (ITP)
The investigators are undertaking a multicentre, randomised controlled trial of 120 adults with newly diagnosed ITP from 5 medical centers in China. Part of the participants are randomly selected to receive caffeic acid tablets combining dexamethasone and the other part are selected to receive high-dose dexamethasone treatment. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
Read the detailed description
All participants' platelet count will be monitored weekly. Response will be evaluated after 3, 6 and 12 months after treatment. If the participant did not get complete response or response after 3 months, he would quit the trail.
- Conditions
- Immune Thrombocytopenia
- Being tested
- Caffeic acid, Dexamethasone, Placebo
- 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.
Caffeic acidDrug
Also called Caffeic acid tablet
Oral administration of caffeic acid tablet 0.3g three times per day for 1 year
DexamethasoneDrug
Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total.
PlaceboDrug
Also called Placebo tablet
Sugar pills manufactured to mimic caffeic acid tablet. Oral administration of placebo tablet 0.3g three times per day for 1 year.
| Study group | Role | What they receive |
|---|---|---|
| caffeic acid tablet and dexamethasone | Experimental | Oral administration of caffeic acid tablet 0.3g three times per day for 1 year. Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total. Receives: Drug: Caffeic acid; Drug: Dexamethasone |
| Placebo and dexamethasone | Active comparator | Oral administration of placebo tablet 0.3g three times per day for 1 year. Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total. Receives: Drug: Dexamethasone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proposed criteria for assessing response to ITP treatments
- Complete response (CR)： A platelet count ≥ 100 * 10^9/L measured on two occasions > 7 days apart and the absence of bleeding.
- Response (R)： A platelet count ≥ 30 * 10^9/L and a greater than two fold increase in platelet count from baseline measured on two occasions > 7 days apart and the absence of bleeding.
- No response (NR)： A platelet count < 30 * 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.
- Relapses: platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.
Measured: 3 months after treatment started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startSep 2012
- Primary completionDec 2013
- Study completionDec 2013
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, Qianfoshan Hospital, Anhui Medical University, Qingdao University
- Responsible party
- Principal investigator, Ming Hou, Shandong University
- Investigators
- Ming Hou, MD, PhD, Principal investigator, Shandong University Qilu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351622
- Sponsor's protocol ID
- ITP-Caffeic acid
- Status last verified
- Mar 2015
- First submitted
- 21 Jan 2015
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
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 Randomized Study of Caffeic Acid Tablets as a Second-line Therapy for the Treatment of Immune Thrombocytopenia (ITP)
- ClinicalTrials.gov ID
- NCT02351622
- Acronym / sponsor ID
- ITP-Caffeic acid
- Conditions
- Immune Thrombocytopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, Qianfoshan Hospital, Anhui Medical University, Qingdao University
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Jan 2015 (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 investigators are undertaking a multicentre, randomised controlled trial of 120 adults with newly diagnosed ITP from 5 medical centers in China. Part of the participants are randomly selected to receive caffeic acid tablets combining dexamethasone and the other part are selected to receive high-dose dexamethasone treatment. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
Detailed description
All participants' platelet count will be monitored weekly. Response will be evaluated after 3, 6 and 12 months after treatment. If the participant did not get complete response or response after 3 months, he would quit the trail.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| caffeic acid tablet and dexamethasone | Experimental | Drug: Caffeic acid, Drug: DexamethasoneOral administration of caffeic acid tablet 0.3g three times per day for 1 year. Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total. |
| Placebo and dexamethasone | Active comparator | Drug: Dexamethasone, Drug: PlaceboOral administration of placebo tablet 0.3g three times per day for 1 year. Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet the diagnostic criteria for immune thrombocytopenia
- Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80 years
- To show a platelet count <30 * 10^9/L, and with bleeding manifestations
- Willing and able to sign written informed consent
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 |
|---|---|---|
| Caffeic acidAlso: Caffeic acid tabletOral administration of caffeic acid tablet 0.3g three times per day for 1 year | Drug | caffeic acid tablet and dexamethasone |
| DexamethasoneOral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total. | Drug | Placebo and dexamethasone, caffeic acid tablet and dexamethasone |
| PlaceboAlso: Placebo tabletSugar pills manufactured to mimic caffeic acid tablet. Oral administration of placebo tablet 0.3g three times per day for 1 year. | Drug | Placebo and dexamethasone |
Primary outcome
Proposed criteria for assessing response to ITP treatments
Time frame: 3 months after treatment started
1. Complete response (CR)： A platelet count ≥ 100 * 10^9/L measured on two occasions > 7 days apart and the absence of bleeding. 2. Response (R)： A platelet count ≥ 30 * 10^9/L and a greater than two fold increase in platelet count from baseline measured on two occasions > 7 days apart and the absence of bleeding. 3. No response (NR)： A platelet count < 30 * 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart. 4. Relapses: platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.
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 20 Apr 2016.
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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, MD, PhD principal investigator
Shandong University Qilu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Caffeic acid and Dexamethasone in people with Immune Thrombocytopenia, 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 4 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: finished, 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.
What does this phase mean?
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?
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?
Proposed criteria for assessing response to ITP treatments (time frame: 3 months after treatment started). 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 20 Apr 2016.