Pregnancy RelatedPhase 2NCT06531525
Effect of Low Molecular Heparin on Pregnancy Outcome With Protein S Deficiency
A Phase 2 study testing Enoxaparin and Aspirin in people with Pregnancy Related and Protein S Deficiency, run by Peking University People's Hospital at 1 site in China.
Trial summary
To evaluate whether low molecular heparin could improve pregnancy outcomes in pregnancies with protein S deficiency. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy Related, Protein S Deficiency
- What is being tested?
- Enoxaparin and Aspirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Plasma activity levels of PS when not pregnant are below the lower limits of the adult reference values (generally about 60-70% for PS) without the use of warfarin. Or, free protein S antigen levels in the second and third trimesters are less than 30% and less than 24%, respectively
- Pregnant women who delivered from Aug 1st, 2024 to Oct 15th, 2027
- One or more family members exhibiting the same symptoms as the patient
- Past history of early onset thrombosis (age 50 or below)
- Repeated recurrence of thrombosis
- Thromboses in unusual sites
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- New onset of thrombosis during current pregnancy or after delivery
- Patients with diagnosis confirmed by gene analysis Inclusion criteria 1 and 2 must always be met regardless of items of 3-8.
- Written informed consent
Who cannot join
- Thrombophilia other than Protein S deficiency
- Antiphospholipid syndrome, systemic lupus erythematosus, platelet abnormalities, vascular disorders, blood flow obstruction, paroxysmal nocturnal hemoglobinuria, malignant tumor and other conditions that tend to cause thrombosis
- Allergy/hypersensitivity to enoxaparin or aspirin
- Heparin-associated thrombocytopenia or thrombocytopenia (platelet count<75 × 10^9/L)
- Organ lesions at risk for bleeding such as acute stomach/bowel ulcers, cerebral hemorrhage, cerebral aneurysm
- uncontrolled hypertension or Severe hypertension (Systolic Blood Pressure >200mmhg and/or Diastolic Blood Pressure >120mmHg)
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- Severe hepatic failure (INR >1.8)
- Serum creatinine greater than 80 umol/L (1.3mg/dl) and an abnormal 24 hour urine creatine clearance (<30ml/min)
- Abnormal uterine cavity on hysterosalpingogram/hysteroscopy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing/Beijing, 100010
Xiao-Hui Zhang, Professor, +8613522338836, zhangxh@bjmu.edu.cn
Meng-Tong Zang, MD, 18744579871, zangztong@163.com
About this study
Official title: A Multicenter, Open-label, Randomized, Controlled, Phase 2 Trial Evaluating Whether Low Molecular Heparin Could Improve Pregnancy Outcomes With Protein S Deficiency
To evaluate whether low molecular heparin could improve pregnancy outcomes in pregnancies with protein S deficiency.
Read the detailed description
This is a parallel-group, multicenter, randomized controlled trial of 48 pregnancies with protein S deficiency in China. Patients are randomized into three groups to receive enoxaparin combined with aspirin, aspirin alone and no intervention. The primary outcome measure is livebirth rate.
- Conditions
- Pregnancy Related, Protein S Deficiency
- Being tested
- Enoxaparin, Aspirin
- Keywords
- Protein S Deficiency, pregnancy, therapy
- Medical subject headings
- Protein S Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Also called lovenox, clexane
Enoxaparin 4000 IU/day by subcutaneous injection at the time of randomization and continued until delivery. Dose adjustments were made throughout the study based on symptoms such as bleeding and thrombosis.
AspirinDrug
Also called ASA
Aspirin 75mg, orally, once daily at the time of randomization and continued until delivery. Dose adjustments were made throughout the study based on symptoms such as bleeding and thrombosis.
EnoxaparinDrug
Also called lovenox, clexane
Participants in all groups will receive daily injections of enoxaparin at a dose of 4000 IU within 6 weeks at postpartum.
| Study group | Role | What they receive |
|---|---|---|
| The combination group | Experimental | Subjects randomized to the combination group will receive daily injections of enoxaparin at a dose of 4000 IU and aspirin 75mg per day orally until delivery. Receives: Drug: Enoxaparin; Drug: Aspirin |
| The Aspirin group | Active comparator | Aspirin will be given at a dose of 75mg, orally, each day until delivery. Receives: Drug: Aspirin |
| No intervention | No intervention | No intervention |
| All groups | Other | Participants in all groups will receive daily injections of enoxaparin at a dose of 4000 IU within 6 weeks at postpartum. Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of livebirth
Incidents of livebirth
Measured: From date of randomization until delivery, assessed up to 42 months
Secondary outcomes (6)
Parameters of maternal coagulation-related indicators
D-Dimer in ng/ml, Protein S activity in %
Measured: From the start of study treatment to 6 weeks post-partum
Parameters to assess the safety of low molecular heparin
Maternal platelet count in 10^9/L, Number of haemorrhagic events, Number of cases of skin reactions at injection site
Measured: From the start of study treatment to 6 weeks post-partum
Other incidents of adverse pregnancy outcomes
early miscarriage (until 12 weeks of gestation), late miscarriage (12-28 weeks of gestation), premature livebirths (28-37 weeks of gestation)
Measured: up to 37 weeks
Neonatal Data
Neonatal weight in grams, Neonatal length in centimetres, Apgar 1-minute, 5-minute, 10-minute scores in scores, Number of neonatal complications
Measured: after the delivery (an expected average of one month)
Incidents of placental insufficiency
Incidents of pre-eclampsia, intrauterine growth retardation, placental abruption, and intrauterine foetal death, etc.
Measured: up to 6 weeks post-partum
Incidents of thrombosis/thromboembolism
thrombosis/thromboembolism
Measured: From the start of study treatment to 6 weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Obstetrics and Gynecology Hospital, Beijing Hospital, Peking Union Medical College Hospital, China-Japan Friendship Hospital, Sichuan Academy of Medical Sciences, Xiangya Hospital of Central South University, Chinese PLA General Hospital, Beijing Friendship Hospital, Beijing Chuiyangliu Hospital
- Responsible party
- Principal investigator, Xiao Hui Zhang, Peking University People's Hospital
- Investigators
- Xiao-Hui Zhang, Professor, Principal investigator, Peking University Insititute of Hematology, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531525
- Sponsor's protocol ID
- PKU-PS-01
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 1 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 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized, Controlled, Phase 2 Trial Evaluating Whether Low Molecular Heparin Could Improve Pregnancy Outcomes With Protein S Deficiency
- ClinicalTrials.gov ID
- NCT06531525
- Acronym / sponsor ID
- PKU-PS-01
- Conditions
- Pregnancy Related, Protein S Deficiency
- Keywords
- Protein S Deficiency, pregnancy, therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Beijing Obstetrics and Gynecology Hospital, Beijing Hospital, Peking Union Medical College Hospital, China-Japan Friendship Hospital, Sichuan Academy of Medical Sciences, Xiangya Hospital of Central South University, Chinese PLA General Hospital, Beijing Friendship Hospital, Beijing Chuiyangliu Hospital
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 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.
To evaluate whether low molecular heparin could improve pregnancy outcomes in pregnancies with protein S deficiency.
Detailed description
This is a parallel-group, multicenter, randomized controlled trial of 48 pregnancies with protein S deficiency in China. Patients are randomized into three groups to receive enoxaparin combined with aspirin, aspirin alone and no intervention. The primary outcome measure is livebirth rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| The combination group | Experimental | Drug: Enoxaparin, Drug: AspirinSubjects randomized to the combination group will receive daily injections of enoxaparin at a dose of 4000 IU and aspirin 75mg per day orally until delivery. |
| The Aspirin group | Active comparator | Drug: AspirinAspirin will be given at a dose of 75mg, orally, each day until delivery. |
| No intervention | No intervention | –No intervention |
| All groups | Other | Drug: EnoxaparinParticipants in all groups will receive daily injections of enoxaparin at a dose of 4000 IU within 6 weeks at postpartum. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Plasma activity levels of PS when not pregnant are below the lower limits of the adult reference values (generally about 60-70% for PS) without the use of warfarin. Or, free protein S antigen levels in the second and third trimesters are less than 30% and less than 24%, respectively
- Pregnant women who delivered from Aug 1st, 2024 to Oct 15th, 2027
- One or more family members exhibiting the same symptoms as the patient
- Past history of early onset thrombosis (age 50 or below)
- Repeated recurrence of thrombosis
Key exclusion criteria (9 listed)
- Thrombophilia other than Protein S deficiency
- Antiphospholipid syndrome, systemic lupus erythematosus, platelet abnormalities, vascular disorders, blood flow obstruction, paroxysmal nocturnal hemoglobinuria, malignant tumor and other conditions that tend to cause thrombosis
- Allergy/hypersensitivity to enoxaparin or aspirin
- Heparin-associated thrombocytopenia or thrombocytopenia (platelet count<75 × 10^9/L)
- Organ lesions at risk for bleeding such as acute stomach/bowel ulcers, cerebral hemorrhage, cerebral aneurysm
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 |
|---|---|---|
| EnoxaparinAlso: lovenox, clexaneEnoxaparin 4000 IU/day by subcutaneous injection at the time of randomization and continued until delivery. Dose adjustments were made throughout the study based on symptoms such as bleeding and thrombosis. | Drug | The combination group |
| AspirinAlso: ASAAspirin 75mg, orally, once daily at the time of randomization and continued until delivery. Dose adjustments were made throughout the study based on symptoms such as bleeding and thrombosis. | Drug | The Aspirin group, The combination group |
| EnoxaparinAlso: lovenox, clexaneParticipants in all groups will receive daily injections of enoxaparin at a dose of 4000 IU within 6 weeks at postpartum. | Drug | All groups |
Primary outcome
Rate of livebirth
Time frame: From date of randomization until delivery, assessed up to 42 months
Incidents of livebirth
6 secondary outcomes
Parameters of maternal coagulation-related indicators
Time frame: From the start of study treatment to 6 weeks post-partum
Parameters to assess the safety of low molecular heparin
Time frame: From the start of study treatment to 6 weeks post-partum
Other incidents of adverse pregnancy outcomes
Time frame: up to 37 weeks
Neonatal Data
Time frame: after the delivery (an expected average of one month)
Incidents of placental insufficiency
Time frame: up to 6 weeks post-partum
Incidents of thrombosis/thromboembolism
Time frame: From the start of study treatment to 6 weeks post-partum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 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.
Xiao-Hui 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 Enoxaparin and Aspirin in people with Pregnancy Related and Protein S Deficiency, 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 9 inclusion and 9 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: opening soon, as of the sponsor's last update on 1 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of livebirth (time frame: From date of randomization until delivery, assessed up to 42 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 1 Aug 2024.