Kaposiform HemangioendotheliomaNCT05351216
The Effect of Sirolimus on Immunizations During the Treatment of Kaposiform Hemangioendothelioma
An observational study of Kaposiform Hemangioendothelioma, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
To research and explore the antibody protection and immune memory after vaccination in children with KHE during sirolimus administration. To explore the feasibility (safety and efficacy) of vaccination in a timely manner during the administration of sirolimus in children with KHE. Read more about this study
- Who is it for?
- Ages Up to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Kaposiform Hemangioendothelioma
- Type of treatment
- Vaccines
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to Mar 2028
- Phase
- Observational
- 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 Up to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The calculation of the sample size came from the previous pre-experiment. Investigator take HBsAb protection rate as the main outcome indicator. The sample size of this study, calculated using a non-inferiority test, was 156 (78 per group). In addition, 10% was required to make up for loss to follow-up, withdrawal, etc. So a total of 174 subjects (87 per group) are anticipated.
Who may be able to join
- Case groups:
- KHE patients treated with sirolimus.
- After immunoglobulin and flow cytometry assays, as well as outpatient evaluation and assessment, those participants will be vaccinated with live attenuated vaccines or inactivated vaccines in a timely order according to the advice.
- Control groups:
- Healthy children with no immune deficiencies.
- Participants are vaccinated according to the National Immunization Program in a timely manner.
- Participants are matched to the case group according to age.
Who cannot join
- HBsAg, HBeAg positive, or other active infectious diseases;
- History of immunodeficiency or low immunoglobulin levels;
- Autoimmune disease or fever during blood collection;
- Use of other medication or surgery;
- Suffering from other bleeding disorders;
- Suffering from other solid tumors or hematological tumors, etc.;
- Withdraw informed consent.
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, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Kai Li, Doctor
About this study
Official title: The Effect of Sirolimus on Time-sequentially Scheduled Immunizations During the Treatment of Kaposiform Hemangioendothelioma: a Case-control Study
To research and explore the antibody protection and immune memory after vaccination in children with KHE during sirolimus administration. To explore the feasibility (safety and efficacy) of vaccination in a timely manner during the administration of sirolimus in children with KHE. To search for back-up plans for vaccination regimens for KHE patients taking sirolimus in children who do not respond to primary vaccination.
Read the detailed description
Children with KHE have an early onset. KHE usually occurs in infants and young children less than 1 year old, of which neonates account for about 38.5%-60% of all cases. Due to the immunosuppressive effect of sirolimus, the vaccination was usually suspended after taking it, and children would be in a state of no immune protection. These children are at greatly increased risk of exposure to microorganisms and consequent infection. Therefore, it is necessary to vaccinate them against infectious diseases. However, vaccination with live vaccines has the potential to cause severe infections through reversion of the vaccine strain to a pathogenic form. Moreover, studies have also shown that protective antibodies are severely affected in transplant patients taking immunosuppressive drugs and in patients with solid tumors after chemotherapy. Loss of immune memory is very common, and marked deficits in B cell function and humoral immunity can persist even for years.
- Conditions
- Kaposiform Hemangioendothelioma
- Keywords
- Following National Vaccination Program, Sirolimus
- Medical subject headings
- Kaposiform Hemangioendothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Cases | Individuals diagnosed with KHE and treated with sirolimus. After immunoglobulin and flow cytometry assays, as well as outpatient evaluation and assessment, those participants will be vaccinated with live attenuated vaccines or inactivated vaccines in a timely order according to the advice. （Sirolimus Rapamycin 0.8mg/m2 bid po） | |
| Controls | Healthy children with no immunodeficiency disease, vaccinated according to the National Immunization Program. Particpants should be age-matched with the case group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titers of Hepatitis B virus surface antibody
Titers of Hepatitis B virus surface antibody，indicating whether there is persistent protective antibodies after vaccination.
Measured: Admission within 1 day
Titers of Hepatitis B virus surface antibody
Titers of Hepatitis B virus surface antibody，indicating whether there is persistent
Measured: The 7th month after admission
Titers of Hepatitis B virus surface antibody
Titers of Hepatitis B virus surface antibody，indicating whether there is persistent
Measured: The 12th month after admission
Titers of Hepatitis B virus surface antibody
Titers of Hepatitis B virus surface antibody，indicating whether there is persistent
Measured: The 18th month after admission
Secondary outcomes (24)
Levels of measles antibodies.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: Admission within 1 day
Levels of mumps antibodies
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: Admission within 1 day
Levels of rubella antibodies.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: Admission within 1 day
Levels of measles antibodies.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: The 7th month after admission
Levels of mumps antibodies.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: The 7th month after admission
Levels of rubella antibodies.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: The 7th month after admission
Levels of measles antibodies.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: The 12th month after admission
Levels of mumps antibodies.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: The 12th month after admission
Levels of rubella antibodies.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: The 12th month after admission
Levels of measles antibodies.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: The 18th month after admission
Levels of mumps antibodies.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: The 18th month after admission
Levels of rubella antibodies.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: The 18th month after admission
Level of Japanese encephalitis antibody.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: Admission within 1 day
Level of Japanese encephalitis antibody.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: The 7th month after admission
Level of Japanese encephalitis antibody.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: The 12th month after admission
Level of Japanese encephalitis antibody.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: The 18th month after admission
Level of varicella antibody
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: Admission within 1 day
Level of varicella antibody.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: The 7th month after admission
Level of varicella antibody.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: The 12th month after admission
Level of varicella antibody.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: The 18th month after admission
Level of COVID-19 antibody.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: Admission within 1 day
Level of COVID-19 antibody.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: The 7th month after admission
Level of COVID-19 antibody.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: The 12th month after admission
Level of COVID-19 antibody.
This outcome indicates whether there is persistent protective antibodies after vaccination.
Measured: The 18th month after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Mar 2021
- Primary completionMar 2026 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Kaposiform HemangioendotheliomaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kai Li, PhD, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351216
- Sponsor's protocol ID
- LK220323
- Status last verified
- Jun 2025
- First submitted
- 30 Mar 2022
- Last updated
- 27 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zignol M, Peracchi M, Tridello G, Pillon M, Fregonese F, D'Elia R, Zanesco L, Cesaro S. Assessment of humoral immunity to poliomyelitis, tetanus, hepatitis B, measles, rubella, and mumps in children after chemotherapy. Cancer. 2004 Aug 1;101(3):635-41. doi: 10.1002/cncr.20384.
PubMed 15274078Kwon HJ, Lee JW, Chung NG, Cho B, Kim HK, Kang JH. Assessment of serologic immunity to diphtheria-tetanus-pertussis after treatment of Korean pediatric hematology and oncology patients. J Korean Med Sci. 2012 Jan;27(1):78-83. doi: 10.3346/jkms.2012.27.1.78. Epub 2011 Dec 19.
PubMed 22219618Zhang J, Xie F, Delzell E, Chen L, Winthrop KL, Lewis JD, Saag KG, Baddley JW, Curtis JR. Association between vaccination for herpes zoster and risk of herpes zoster infection among older patients with selected immune-mediated diseases. JAMA. 2012 Jul 4;308(1):43-9. doi: 10.1001/jama.2012.7304.
PubMed 22760290Kawano Y, Suzuki M, Kawada J, Kimura H, Kamei H, Ohnishi Y, Ono Y, Uchida H, Ogura Y, Ito Y. Effectiveness and safety of immunization with live-attenuated and inactivated vaccines for pediatric liver transplantation recipients. Vaccine. 2015 Mar 17;33(12):1440-5. doi: 10.1016/j.vaccine.2015.01.075. Epub 2015 Feb 7.
PubMed 25665961Inoue T, Moran I, Shinnakasu R, Phan TG, Kurosaki T. Generation of memory B cells and their reactivation. Immunol Rev. 2018 May;283(1):138-149. doi: 10.1111/imr.12640.
PubMed 29664566Vink P, Ramon Torrell JM, Sanchez Fructuoso A, Kim SJ, Kim SI, Zaltzman J, Ortiz F, Campistol Plana JM, Fernandez Rodriguez AM, Rebollo Rodrigo H, Campins Marti M, Perez R, Gonzalez Roncero FM, Kumar D, Chiang YJ, Doucette K, Pipeleers L, Aguera Morales ML, Rodriguez-Ferrero ML, Secchi A, McNeil SA, Campora L, Di Paolo E, El Idrissi M, Lopez-Fauqued M, Salaun B, Heineman TC, Oostvogels L; Z-041 Study Group. Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial. Clin Infect Dis. 2020 Jan 2;70(2):181-190. doi: 10.1093/cid/ciz177.
PubMed 30843046Saghafian-Hedengren S, Soderstrom I, Sverremark-Ekstrom E, Nilsson A. Insights into defective serological memory after acute lymphoblastic leukaemia treatment: The role of the plasma cell survival niche, memory B-cells and gut microbiota in vaccine responses. Blood Rev. 2018 Jan;32(1):71-80. doi: 10.1016/j.blre.2017.08.009. Epub 2017 Aug 26.
PubMed 28886882Horns F, Dekker CL, Quake SR. Memory B Cell Activation, Broad Anti-influenza Antibodies, and Bystander Activation Revealed by Single-Cell Transcriptomics. Cell Rep. 2020 Jan 21;30(3):905-913.e6. doi: 10.1016/j.celrep.2019.12.063.
PubMed 31968262Dini G, Toletone A, Barberis I, Debarbieri N, Massa E, Paganino C, Bersi F, Montecucco A, Alicino C, Durando P. Persistence of protective anti-HBs antibody levels and anamnestic response to HBV booster vaccination: A cross-sectional study among healthcare students 20 years following the universal immunization campaign in Italy. Hum Vaccin Immunother. 2017 Feb;13(2):440-444. doi: 10.1080/21645515.2017.1264788.
PubMed 27925503Zhang L, Thornton CP, Ruble K, Cooper SL. Post-Chemotherapy Titer Status and Need for Revaccination After Treatment for Childhood Cancer. Clin Pediatr (Phila). 2020 Jun;59(6):606-613. doi: 10.1177/0009922820915884.
PubMed 32423345
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sirolimus on Time-sequentially Scheduled Immunizations During the Treatment of Kaposiform Hemangioendothelioma: a Case-control Study
- ClinicalTrials.gov ID
- NCT05351216
- Acronym / sponsor ID
- LK220323
- Conditions
- Kaposiform Hemangioendothelioma
- Keywords
- Following National Vaccination Program, Sirolimus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 28 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.
To research and explore the antibody protection and immune memory after vaccination in children with KHE during sirolimus administration. To explore the feasibility (safety and efficacy) of vaccination in a timely manner during the administration of sirolimus in children with KHE. To search for back-up plans for vaccination regimens for KHE patients taking sirolimus in children who do not respond to primary vaccination.
Detailed description
Children with KHE have an early onset. KHE usually occurs in infants and young children less than 1 year old, of which neonates account for about 38.5%-60% of all cases. Due to the immunosuppressive effect of sirolimus, the vaccination was usually suspended after taking it, and children would be in a state of no immune protection. These children are at greatly increased risk of exposure to microorganisms and consequent infection. Therefore, it is necessary to vaccinate them against infectious diseases. However, vaccination with live vaccines has the potential to cause severe infections through reversion of the vaccine strain to a pathogenic form. Moreover, studies have also shown that protective antibodies are severely affected in transplant patients taking immunosuppressive drugs and in patients with solid tumors after chemotherapy. Loss of immune memory is very common, and marked deficits in B cell function and humoral immunity can persist even for years.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Individuals diagnosed with KHE and treated with sirolimus. After immunoglobulin and flow cytometry assays, as well as outpatient evaluation and assessment, those participants will be vaccinated with live attenuated vaccines or inactivated vaccines in a timely order according to the advice. （Sirolimus Rapamycin 0.8mg/m2 bid po） |
| Controls | – | –Healthy children with no immunodeficiency disease, vaccinated according to the National Immunization Program. Particpants should be age-matched with the case group. |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The calculation of the sample size came from the previous pre-experiment. Investigator take HBsAb protection rate as the main outcome indicator. The sample size of this study, calculated using a non-inferiority test, was 156 (78 per group). In addition, 10% was required to make up for loss to follow-up, withdrawal, etc. So a total of 174 subjects (87 per group) are anticipated.
Key inclusion criteria (7 listed)
- Case groups:
- KHE patients treated with sirolimus.
- After immunoglobulin and flow cytometry assays, as well as outpatient evaluation and assessment, those participants will be vaccinated with live attenuated vaccines or inactivated vaccines in a timely order according to the advice.
- Control groups:
- Healthy children with no immune deficiencies.
Key exclusion criteria (7 listed)
- HBsAg, HBeAg positive, or other active infectious diseases;
- History of immunodeficiency or low immunoglobulin levels;
- Autoimmune disease or fever during blood collection;
- Use of other medication or surgery;
- Suffering from other bleeding disorders;
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 |
|---|---|---|
| No intervention | Other | Cases, Controls |
Primary outcome
Titers of Hepatitis B virus surface antibody
Time frame: Admission within 1 day
Titers of Hepatitis B virus surface antibody，indicating whether there is persistent protective antibodies after vaccination.
Titers of Hepatitis B virus surface antibody
Time frame: The 7th month after admission
Titers of Hepatitis B virus surface antibody，indicating whether there is persistent
Titers of Hepatitis B virus surface antibody
Time frame: The 12th month after admission
Titers of Hepatitis B virus surface antibody，indicating whether there is persistent
Titers of Hepatitis B virus surface antibody
Time frame: The 18th month after admission
Titers of Hepatitis B virus surface antibody，indicating whether there is persistent
24 secondary outcomes
Levels of measles antibodies.
Time frame: Admission within 1 day
Levels of mumps antibodies
Time frame: Admission within 1 day
Levels of rubella antibodies.
Time frame: Admission within 1 day
Levels of measles antibodies.
Time frame: The 7th month after admission
Levels of mumps antibodies.
Time frame: The 7th month after admission
Levels of rubella antibodies.
Time frame: The 7th month after admission
Levels of measles antibodies.
Time frame: The 12th month after admission
Levels of mumps antibodies.
Time frame: The 12th month after admission
Levels of rubella antibodies.
Time frame: The 12th month after admission
Levels of measles antibodies.
Time frame: The 18th month after admission
Levels of mumps antibodies.
Time frame: The 18th month after admission
Levels of rubella antibodies.
Time frame: The 18th month after admission
Level of Japanese encephalitis antibody.
Time frame: Admission within 1 day
Level of Japanese encephalitis antibody.
Time frame: The 7th month after admission
Level of Japanese encephalitis antibody.
Time frame: The 12th month after admission
Level of Japanese encephalitis antibody.
Time frame: The 18th month after admission
Level of varicella antibody
Time frame: Admission within 1 day
Level of varicella antibody.
Time frame: The 7th month after admission
Level of varicella antibody.
Time frame: The 12th month after admission
Level of varicella antibody.
Time frame: The 18th month after admission
Level of COVID-19 antibody.
Time frame: Admission within 1 day
Level of COVID-19 antibody.
Time frame: The 7th month after admission
Level of COVID-19 antibody.
Time frame: The 12th month after admission
Level of COVID-19 antibody.
Time frame: The 18th month after admission
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 27 Jun 2025.
- Background: PubMed 15274078Zignol M, Peracchi M, Tridello G, Pillon M, Fregonese F, D'Elia R, Zanesco L, Cesaro S. Assessment of humoral immunity to poliomyelitis, tetanus, hepatitis B, measles, rubella, and mumps in children after chemotherapy. Cancer. 2004 Aug 1;101(3):635-41. doi: 10.1002/cncr.20384.
- Background: PubMed 22219618Kwon HJ, Lee JW, Chung NG, Cho B, Kim HK, Kang JH. Assessment of serologic immunity to diphtheria-tetanus-pertussis after treatment of Korean pediatric hematology and oncology patients. J Korean Med Sci. 2012 Jan;27(1):78-83. doi: 10.3346/jkms.2012.27.1.78. Epub 2011 Dec 19.
- Background: PubMed 22760290Zhang J, Xie F, Delzell E, Chen L, Winthrop KL, Lewis JD, Saag KG, Baddley JW, Curtis JR. Association between vaccination for herpes zoster and risk of herpes zoster infection among older patients with selected immune-mediated diseases. JAMA. 2012 Jul 4;308(1):43-9. doi: 10.1001/jama.2012.7304.
- Background: PubMed 25665961Kawano Y, Suzuki M, Kawada J, Kimura H, Kamei H, Ohnishi Y, Ono Y, Uchida H, Ogura Y, Ito Y. Effectiveness and safety of immunization with live-attenuated and inactivated vaccines for pediatric liver transplantation recipients. Vaccine. 2015 Mar 17;33(12):1440-5. doi: 10.1016/j.vaccine.2015.01.075. Epub 2015 Feb 7.
- Background: PubMed 29664566Inoue T, Moran I, Shinnakasu R, Phan TG, Kurosaki T. Generation of memory B cells and their reactivation. Immunol Rev. 2018 May;283(1):138-149. doi: 10.1111/imr.12640.
- Background: PubMed 30843046Vink P, Ramon Torrell JM, Sanchez Fructuoso A, Kim SJ, Kim SI, Zaltzman J, Ortiz F, Campistol Plana JM, Fernandez Rodriguez AM, Rebollo Rodrigo H, Campins Marti M, Perez R, Gonzalez Roncero FM, Kumar D, Chiang YJ, Doucette K, Pipeleers L, Aguera Morales ML, Rodriguez-Ferrero ML, Secchi A, McNeil SA, Campora L, Di Paolo E, El Idrissi M, Lopez-Fauqued M, Salaun B, Heineman TC, Oostvogels L; Z-041 Study Group. Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial. Clin Infect Dis. 2020 Jan 2;70(2):181-190. doi: 10.1093/cid/ciz177.
- Background: PubMed 28886882Saghafian-Hedengren S, Soderstrom I, Sverremark-Ekstrom E, Nilsson A. Insights into defective serological memory after acute lymphoblastic leukaemia treatment: The role of the plasma cell survival niche, memory B-cells and gut microbiota in vaccine responses. Blood Rev. 2018 Jan;32(1):71-80. doi: 10.1016/j.blre.2017.08.009. Epub 2017 Aug 26.
- Background: PubMed 31968262Horns F, Dekker CL, Quake SR. Memory B Cell Activation, Broad Anti-influenza Antibodies, and Bystander Activation Revealed by Single-Cell Transcriptomics. Cell Rep. 2020 Jan 21;30(3):905-913.e6. doi: 10.1016/j.celrep.2019.12.063.
- Background: PubMed 27925503Dini G, Toletone A, Barberis I, Debarbieri N, Massa E, Paganino C, Bersi F, Montecucco A, Alicino C, Durando P. Persistence of protective anti-HBs antibody levels and anamnestic response to HBV booster vaccination: A cross-sectional study among healthcare students 20 years following the universal immunization campaign in Italy. Hum Vaccin Immunother. 2017 Feb;13(2):440-444. doi: 10.1080/21645515.2017.1264788.
- Background: PubMed 32423345Zhang L, Thornton CP, Ruble K, Cooper SL. Post-Chemotherapy Titer Status and Need for Revaccination After Treatment for Childhood Cancer. Clin Pediatr (Phila). 2020 Jun;59(6):606-613. doi: 10.1177/0009922820915884.
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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.
Kai Li, PhD principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kaposiform Hemangioendothelioma, run by Children's Hospital of Fudan 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 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: looking for participants now, as of the sponsor's last update on 27 Jun 2025. 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.
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 Kai Li, PhD (02164931114, likai2727@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Titers of Hepatitis B virus surface antibody (time frame: Admission within 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05351216, which also lists 10 linked publications.
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 27 Jun 2025.