Immune ThrombocytopeniaPhase 2NCT05333744
The Combination of Prednisone and Recombinant Human Thrombopoietin for Treatment of Immune Thrombocytopenia in Pregnancy
A Phase 2 study testing Prednisone and Recombinant Human TPO in people with Immune Thrombocytopenia, run by Peking University People's Hospital at 1 site in China.
Trial summary
Randomized, open-label study to compare the efficacy and safety of prednisone plus recombinant human thrombopoietin (rhTPO) compared to prednisone monotherapy for the treatment of immune thrombocytopenia in pregnancy Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- Prednisone and Recombinant Human TPO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 Sep 2022
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-49;
- Gestational weeks ≥20 weeks;
- Platelet count <30×10^9/L, accompanied with or without bleeding symptoms;
- Confirmed diagnosed, treatment-naive ITP in pregnancy;
- Willing and able to sign written informed consent.
Who cannot join
- Secondary ITP such as drug-related thrombocytopenia;
- Thrombocytopenia caused by viral infection (HIV, hepatitis B or hepatitis C); Other autoimmune diseases (including positive anti-nuclear antibodies, positive anti-cardiolipin antibodies, positive lupus anticoagulant factors, and positive Coombs) with severe heart, kidney, liver or respiratory dysfunction;
- Severe immunodeficiency;
- Myelodysplastic or myeloid fibrosis;
- History of malignancy.
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
Xiao-hui Zhang, Professor, zhangxh100@sina.com
About this study
Official title: The Combination of Prednisone and Recombinant Human Thrombopoietin vs Prednisone Monotherapy for Treatment in Immune Thrombocytopenia in Pregnancy
Randomized, open-label study to compare the efficacy and safety of prednisone plus recombinant human thrombopoietin (rhTPO) compared to prednisone monotherapy for the treatment of immune thrombocytopenia in pregnancy
Read the detailed description
The investigators are undertaking a parallel group, randomized controlled trial of adults with ITP in pregnancy in China. Patients were randomized to prednisone plus rhTPO and prednisone monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
- Conditions
- Immune Thrombocytopenia
- Being tested
- Prednisone, Recombinant Human TPO
- 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
Prednisone po, 20mg per day for 2 weeks, if response (Plt 30-100×100^g/L),gradually taper to the maintenance dose（5-10mg per day）until 6 weeks after delivery; if not response, gradually taper to withdrawal.
Recombinant Human TPODrug
Also called rhTPO
rhTPO im, 300U/kg per day for 2 weeks, if response (Plt 30-100×100^g/L), taper to 300U/kg for twice per week until 6 weeks after delivery; if not response, drug withdrawal.
| Study group | Role | What they receive |
|---|---|---|
| Prednisone plus rhTPO | Experimental | Prednisone 20mg per day, 2 weeks and rhTPO 300U/kg per day, 2 weeks Receives: Drug: Prednisone; Drug: Recombinant Human TPO |
| Prednisone | Active comparator | Prednisone 20mg per day, 2 weeks Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Response (R) as platelet count more than 30,000 per cubic millimeter and at least 2-fold increase of the baseline count and absence of bleeding.
Measured: day 14
Platelet counts at delivery
Platelet counts at delivery
Measured: At delivery
Secondary outcomes (5)
Number of patients with bleeding
Number of patients with bleeding symptome
Measured: During treatment（up to 6 weeks after delivery）
Number of patients with adverse events
Number of patients with adverse events
Measured: During treatment（up to 6 weeks after delivery）
Platelet counts of newborns
Platelet counts of newborns
Measured: at delivery
Number of newborns with adverse events
Number of newborns with adverse events
Measured: During treatment（up to 6 weeks after delivery）
Loss of response
Platelet counts below 100 x 109/L or bleeding (from CR) or platelet counts below 30 x 109/L, less than 2-fold increase of baseline platelet count or bleeding (from R)
Measured: During treatment（up to 6 weeks after delivery）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Jun 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Sep 2022 (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
- 90 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
- Xiao-hui Zhang, Professor, Principal investigator, Peking University People's Hospital, Peking University Insititute of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333744
- Sponsor's protocol ID
- ITP-PKU2204
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 19 Apr 2022
- 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 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of Prednisone and Recombinant Human Thrombopoietin vs Prednisone Monotherapy for Treatment in Immune Thrombocytopenia in Pregnancy
- ClinicalTrials.gov ID
- NCT05333744
- Acronym / sponsor ID
- ITP-PKU2204
- Conditions
- Immune Thrombocytopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 19 Apr 2022 (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.
Randomized, open-label study to compare the efficacy and safety of prednisone plus recombinant human thrombopoietin (rhTPO) compared to prednisone monotherapy for the treatment of immune thrombocytopenia in pregnancy
Detailed description
The investigators are undertaking a parallel group, randomized controlled trial of adults with ITP in pregnancy in China. Patients were randomized to prednisone plus rhTPO and prednisone monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone plus rhTPO | Experimental | Drug: Prednisone, Drug: Recombinant Human TPOPrednisone 20mg per day, 2 weeks and rhTPO 300U/kg per day, 2 weeks |
| Prednisone | Active comparator | Drug: PrednisonePrednisone 20mg per day, 2 weeks |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-49;
- Gestational weeks ≥20 weeks;
- Platelet count <30×10^9/L, accompanied with or without bleeding symptoms;
- Confirmed diagnosed, treatment-naive ITP in pregnancy;
- Willing and able to sign written informed consent.
Key exclusion criteria (5 listed)
- Secondary ITP such as drug-related thrombocytopenia;
- Thrombocytopenia caused by viral infection (HIV, hepatitis B or hepatitis C); Other autoimmune diseases (including positive anti-nuclear antibodies, positive anti-cardiolipin antibodies, positive lupus anticoagulant factors, and positive Coombs) with severe heart, kidney, liver or respiratory dysfunction;
- Severe immunodeficiency;
- Myelodysplastic or myeloid fibrosis;
- History of malignancy.
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 |
|---|---|---|
| PrednisonePrednisone po, 20mg per day for 2 weeks, if response (Plt 30-100×100^g/L),gradually taper to the maintenance dose（5-10mg per day）until 6 weeks after delivery; if not response, gradually taper to withdrawal. | Drug | Prednisone, Prednisone plus rhTPO |
| Recombinant Human TPOAlso: rhTPOrhTPO im, 300U/kg per day for 2 weeks, if response (Plt 30-100×100^g/L), taper to 300U/kg for twice per week until 6 weeks after delivery; if not response, drug withdrawal. | Drug | Prednisone plus rhTPO |
Primary outcome
Response
Time frame: day 14
Response (R) as platelet count more than 30,000 per cubic millimeter and at least 2-fold increase of the baseline count and absence of bleeding.
Platelet counts at delivery
Time frame: At delivery
Platelet counts at delivery
5 secondary outcomes
Number of patients with bleeding
Time frame: During treatment（up to 6 weeks after delivery）
Number of patients with adverse events
Time frame: During treatment（up to 6 weeks after delivery）
Platelet counts of newborns
Time frame: at delivery
Number of newborns with adverse events
Time frame: During treatment（up to 6 weeks after delivery）
Loss of response
Time frame: During treatment（up to 6 weeks after delivery）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
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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.
Xiao-hui Zhang, Professor principal investigator
Peking University People's Hospital, Peking University Insititute of Hematology
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 Recombinant Human TPO 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 5 inclusion and 5 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 19 Apr 2022. 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 Xiao-hui 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?
Response (time frame: day 14). The study lists 2 primary outcomes in all. 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 19 Apr 2022.