Immune ThrombocytopeniaPhase 2IVIgNCT06577909
Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy
A Phase 2 study testing Prednisone and IVIg in people with Immune Thrombocytopenia, run by Peking University People's Hospital at 1 site in China.
Trial summary
This is a prospective, randomized, open-label, multicenter clinical trial study to compare the efficacy and safety of prednisone plus IVIg to prednisone monotherapy in the treatment of immune thrombocytopenia (ITP) in pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- Prednisone and IVIg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2023to 31 Dec 2025
- Phase
- Phase 2
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50 years old;
- Meet the diagnostic criteria for immune thrombocytopenia;
- Pregnant women with ITP without ITP-specific treatments during pregnancy;
- Gestational weeks ≥12 weeks;
- Platelet count <30×10^9/L, accompanied with or without bleeding symptoms.
- Willing and able to sign written informed consent.
Who cannot join
- Have a known diagnosis of other autoimmune diseases, confirmed medical history or laboratory findings within positive anti-nuclear antibodies (>1:80), anti-cardiolipin antibodies, lupus anticoagulant factors or direct Coombs' test.
- Thrombocytopenia caused by pregnancy-specific conditions, such as gestational thrombocytopenia, preeclampsia, the HELLP syndrome and acute fatty liver of pregnancy.
- Secondary thrombocytopenia such as drug-related thrombocytopenia, vaccine-related thrombocytopenia, lymphoproliferative disorders, severe infection, hepatic cirrhosis and so on.
- With other underlying diseases that may cause thrombocytopenia, such as: malignant disease, megaloblastic anemia, aplastic anemia, myelodysplasia syndrome, myeloid fibrosis, disseminated intravascular coagulation, thrombotic thrombocytopenic purpura, Hemolytic uremic syndrome, disseminated intravascular coagulation and so on;
- Current HIV infection or hepatitis B virus or hepatitis C virus infections;
- With severe heart, kidney, liver or respiratory dysfunction;
- With the medical history of mental illness;
- Have allergic reaction to prednisone or IVIg;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, 100010
Xiaohui Zhang, MD, +8613522338836, zhangxh100@sina.com
Haixia Fu, MD, 13581830157, fuhaixia_210@163.com
About this study
Official title: Prednisone Plus IVIg Compared With Prednisone for Immune Thrombocytopenia During Pregnancy
This is a prospective, randomized, open-label, multicenter clinical trial study to compare the efficacy and safety of prednisone plus IVIg to prednisone monotherapy in the treatment of immune thrombocytopenia (ITP) in pregnancy.
Read the detailed description
The investigators are undertaking a prospective, parallel group, multicenter, randomized controlled trial in pregnant patients with treat-naive ITP. A total of 100 participants are randomized to two groups with the 1:1 ratio: prednisone plus IVIg group versus prednisone monotherapy group. Participants will receive prednisone 20mg per day for 4 weeks plus IVIg 400mg/Kg (total dose ≤20g per day) for 5 days or prednisone 20mg monotherapy per day for 4 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Time to response and platelet counts of newborns are investigated. Adverse events including participants and their newborns are also recorded throughout and after the study.
- Conditions
- Immune Thrombocytopenia
- Being tested
- Prednisone, IVIg
- Keywords
- immune thrombocytopenia, pregnancy, therapy
- 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.
PrednisoneDrug
Also called Pre
Prednisone po, 20mg per day for 4 weeks, if response (Plt 30-100×100^g/L), gradually taper to the maintenance dose of 5-10mg per day until 6 weeks after delivery; if not response, gradually taper to withdrawal.
IVIgDrug
Also called intravenous immunoglobulin
IVIg 400mg/kg (≤20g for the total dose) per day for 5 days, and repeated in the case of lack of response by day 14
| Study group | Role | What they receive |
|---|---|---|
| The combination group | Experimental | Prednisone 20mg per day×4 weeks and IVIg 400mg/kg per day（≤20g per day）×5 days Receives: Drug: Prednisone; Drug: IVIg |
| The prednisone group | Active comparator | Prednisone 20mg per day×4 weeks Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response
Achieving a platelet count of≥30×10^9/L and at least a doubling of the baseline platelet count without administration of any other ITP-specific treatment, and the absence of bleeding
Measured: 4 weeks
Secondary outcomes (8)
Complete Response
Platelet count ≥100×10^9/L measured on 2 occasions at least 7 days apart and the absence of bleeding
Measured: 4 weeks
Early response
Platelet count ≥30×10^9/L and at least doubling baseline at 1 week
Measured: 1 week
relapse
After the treatment is effective, the platelet count drops below 30×10^9/L or drops to less than 2 times the basal value, or bleeding symptoms occur
Measured: 1 year
Time to Response
The day achieving OR
Measured: 4 weeks
Time to relapse (duration of efficacy)
The time from achievement of CR or R to time of relapse
Measured: 1 year
Platelet counts at delivery
Platelet counts at delivery
Measured: At delivery
Platelet counts of newborns
Platelet counts of d1, 3, and 7 of newborns, extended to d42 if thrombocytopenia occurs
Measured: up to 42 days per newborn
Adverse events in parturients
up to 2 years per subject
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 posted29 Aug 2024
- Study start19 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Hui Zhang, Peking University People's Hospital
- Investigators
- Xiaohui Zhang, Professor, Principal investigator, Peking University Insititute of Hematology, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577909
- Sponsor's protocol ID
- PKU-ITP023
- Acronym
- IVIg
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prednisone Plus IVIg Compared With Prednisone for Immune Thrombocytopenia During Pregnancy
- ClinicalTrials.gov ID
- NCT06577909
- Acronym / sponsor ID
- IVIg / PKU-ITP023
- Conditions
- Immune Thrombocytopenia
- Keywords
- immune thrombocytopenia, pregnancy, therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Aug 2024 (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.
This is a prospective, randomized, open-label, multicenter clinical trial study to compare the efficacy and safety of prednisone plus IVIg to prednisone monotherapy in the treatment of immune thrombocytopenia (ITP) in pregnancy.
Detailed description
The investigators are undertaking a prospective, parallel group, multicenter, randomized controlled trial in pregnant patients with treat-naive ITP. A total of 100 participants are randomized to two groups with the 1:1 ratio: prednisone plus IVIg group versus prednisone monotherapy group. Participants will receive prednisone 20mg per day for 4 weeks plus IVIg 400mg/Kg (total dose ≤20g per day) for 5 days or prednisone 20mg monotherapy per day for 4 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Time to response and platelet counts of newborns are investigated. Adverse events including participants and their newborns are also recorded throughout and after the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The combination group | Experimental | Drug: Prednisone, Drug: IVIgPrednisone 20mg per day×4 weeks and IVIg 400mg/kg per day（≤20g per day）×5 days |
| The prednisone group | Active comparator | Drug: PrednisonePrednisone 20mg per day×4 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-50 years old;
- Meet the diagnostic criteria for immune thrombocytopenia;
- Pregnant women with ITP without ITP-specific treatments during pregnancy;
- Gestational weeks ≥12 weeks;
- Platelet count <30×10^9/L, accompanied with or without bleeding symptoms.
Key exclusion criteria (8 listed)
- Have a known diagnosis of other autoimmune diseases, confirmed medical history or laboratory findings within positive anti-nuclear antibodies (>1:80), anti-cardiolipin antibodies, lupus anticoagulant factors or direct Coombs' test.
- Thrombocytopenia caused by pregnancy-specific conditions, such as gestational thrombocytopenia, preeclampsia, the HELLP syndrome and acute fatty liver of pregnancy.
- Secondary thrombocytopenia such as drug-related thrombocytopenia, vaccine-related thrombocytopenia, lymphoproliferative disorders, severe infection, hepatic cirrhosis and so on.
- With other underlying diseases that may cause thrombocytopenia, such as: malignant disease, megaloblastic anemia, aplastic anemia, myelodysplasia syndrome, myeloid fibrosis, disseminated intravascular coagulation, thrombotic thrombocytopenic purpura, Hemolytic uremic syndrome, disseminated intravascular coagulation and so on;
- Current HIV infection or hepatitis B virus or hepatitis C virus infections;
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 |
|---|---|---|
| PrednisoneAlso: PrePrednisone po, 20mg per day for 4 weeks, if response (Plt 30-100×100^g/L), gradually taper to the maintenance dose of 5-10mg per day until 6 weeks after delivery; if not response, gradually taper to withdrawal. | Drug | The combination group, The prednisone group |
| IVIgAlso: intravenous immunoglobulinIVIg 400mg/kg (≤20g for the total dose) per day for 5 days, and repeated in the case of lack of response by day 14 | Drug | The combination group |
Primary outcome
Overall Response
Time frame: 4 weeks
Achieving a platelet count of≥30×10^9/L and at least a doubling of the baseline platelet count without administration of any other ITP-specific treatment, and the absence of bleeding
8 secondary outcomes
Complete Response
Time frame: 4 weeks
Early response
Time frame: 1 week
relapse
Time frame: 1 year
Time to Response
Time frame: 4 weeks
Time to relapse (duration of efficacy)
Time frame: 1 year
Platelet counts at delivery
Time frame: At delivery
Platelet counts of newborns
Time frame: up to 42 days per newborn
Adverse events in parturients
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 29 Aug 2024.
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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.
Xiaohui Zhang, Professor principal investigator
Peking University Insititute of Hematology, Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prednisone and IVIg in people with Immune Thrombocytopenia, run by Peking University People's Hospital 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 6 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 29 Aug 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xiaohui Zhang, Professor (+8613522338836, zhangxh100@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response (time frame: 4 weeks). 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 29 Aug 2024.