Immune ThrombocytopeniaPhase 2/3NCT02751593
Thrombocytopenia in Gestational Period
A Phase 2/3 study testing Dexamethasone in people with Immune Thrombocytopenia and Pregnancy, run by Peking University People's Hospital.
Trial summary
The project was undertaking by Peking University People's Hospital and other well-known hospitals in China. Aims at evaluating efficacy and safety of dexamethasone in management of ITP in pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Immune Thrombocytopenia, Pregnancy
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2017
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subject is between 20-50 years old.
- After 12 weeks gestation.
- Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
- Patients who have no response or relapsed after Corticosteroid or IVIG.
- Patients developed refractoriness to platelet transfusion.
- 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.
- 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).
- 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.
About this study
The project was undertaking by Peking University People's Hospital and other well-known hospitals in China. Aims at evaluating efficacy and safety of dexamethasone in management of ITP in pregnancy.
Read the detailed description
The investigators are undertaking a multicenter, open-labeled, pilot study of 50 ITP patients in pregnancy from Peking University People's Hospital and other well-known hospitals in China. ITP patients in pregnancy who failed to respond to prednisone, IVIG and developed refractoriness to platelet transfusion will be given dexamethasone intravenously at a dose of 40mg every day for four days. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Adverse events will be recorded throughout the study.
- Conditions
- Immune Thrombocytopenia, Pregnancy
- Being tested
- Dexamethasone
- Keywords
- pregnancy, Immune Thrombocytopenia, dexamethasone
- 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.
DexamethasoneDrug
dexamethasone 40mg/d for 4 days
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone | Experimental | 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.
Response rate (CR+R)
Measured: 3 months
Secondary outcomes (3)
Platelet count
Measured: 2 years
Adverse events
Measured: 2 years
live birth rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (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.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiao-hui Zhang, Dr, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751593
- Sponsor's protocol ID
- pregnancy and thrombocytopenia
- Status last verified
- Apr 2016
- First submitted
- 17 Apr 2016
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombocytopenia in Gestational Period
- ClinicalTrials.gov ID
- NCT02751593
- Acronym / sponsor ID
- pregnancy and thrombocytopenia
- Conditions
- Immune Thrombocytopenia, Pregnancy
- Keywords
- pregnancy, Immune Thrombocytopenia, dexamethasone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 26 Apr 2016 (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 project was undertaking by Peking University People's Hospital and other well-known hospitals in China. Aims at evaluating efficacy and safety of dexamethasone in management of ITP in pregnancy.
Detailed description
The investigators are undertaking a multicenter, open-labeled, pilot study of 50 ITP patients in pregnancy from Peking University People's Hospital and other well-known hospitals in China. ITP patients in pregnancy who failed to respond to prednisone, IVIG and developed refractoriness to platelet transfusion will be given dexamethasone intravenously at a dose of 40mg every day for four days. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Adverse events will be recorded throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dexamethasone | Experimental | Drug: Dexamethasonedexamethasone 40mg/d for 4 days |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is between 20-50 years old.
- After 12 weeks gestation.
- Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
- Patients who have no response or relapsed after Corticosteroid or IVIG.
- Patients developed refractoriness to platelet transfusion.
Key exclusion criteria (7 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.
- 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 |
|---|---|---|
| Dexamethasonedexamethasone 40mg/d for 4 days | Drug | dexamethasone |
Primary outcome
Response rate (CR+R)
Time frame: 3 months
3 secondary outcomes
Platelet count
Time frame: 2 years
Adverse events
Time frame: 2 years
live birth rate
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Immune Thrombocytopenia
RecruitingPhase 3
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
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 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.
Xiao-hui Zhang, Dr study chair
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexamethasone in people with Immune Thrombocytopenia and Pregnancy, run by Peking University People's Hospital.
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 7 inclusion and 7 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 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Response rate (CR+R) (time frame: 3 months). 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 26 Apr 2016.