Invasive Fungal DiseaseNCT06698211
Posaconazole Tablet As Primary Prophylaxis of HSCT Patients with Gastrointestinal GVHD
An observational study of Invasive Fungal Disease and Graft Versus Host Disease, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is a prospective investigation using a nonrandomized, single-arm design. Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Invasive Fungal Disease, Graft Versus Host Disease, Hematopoietic Stem Cell Transplantation
- What is being tested?
- Posaconazole tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Jan 2025
- How long will I take part?
- 100 Days
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Patient undergoing Hematopoietic stem cell transplantation who meet the inclusion criteria and do not meet the exclusion criteria can enroll in this study. 2. Ages eligible for study: 18-75 3. Sexes eligible for study: All 4. Race: Chinese 5. Ethnicity: All
Who may be able to join
- Patients with hematologic diseases who undergoes hematopoietic stem cell transplantation.
- Patients who receive Posaconazole tablet as primary prophylaxis of invasive fungal disease.
- Patients developing or developed acute gastrointestinal GVHD which require systemic immunosuppressive therapy of corticosteroids with- or-without other immunosuppressive agents including calcineurin inhibitors.
- Gastrointestinal GVHD grades (I-IV) were recorded according to the Glucksberg criteria.
- Patients themselves or their authorized clients agree to participate in the clinical study and sign the informed consent
Who cannot join
- refuse to enroll
- patients have known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study medication used.
- pregnant or lactating females
- take drugs known to interfere with azole antifungal agents, including terfenadine, cisapride and ebastine, within 24h before Posaconazole application; astemizole at enrollment or within 10 days before Posaconazole application; or cimetidine, rifampin, carbamazepine, phenytoin, rifamycin, barbiturates, isoniazid, catharanthine and anthracyclines within 24 h before Posaconazole application
- have an ECG with a prolonged QTc interval (QTc greater than 500 ms);
- have severe renal insufficiency, alanine transaminase, aspartate transaminase, alkaline phosphatase or total bilirubin levels more than two-times the upper limit of normal;
- patients are expected to survive no more than 72 h;
- Those with evidence of active fungal infection within 3 weeks prior to enrollment
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
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, 300020
About this study
Official title: Evaluation of Posaconazole Tablet As Primary Prophylaxis of Hematopoietic Stem Cell Transplant Patients with Gastrointestinal GVHD
This is a prospective investigation using a nonrandomized, single-arm design. Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined.
Read the detailed description
This is a prospective investigation using a nonrandomized, single-arm design. Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined. Once patients developed GI GVHD, first line therapy and second line treatment will be reviewed according to the condition, besides which the Posaconazole plasma concentration would be detected again on the first, third and fifth day after onset of GI GVHD symptoms to monitor the impact of GI GVHD on the Posaconazole plasma concentration. The primary endpoint was the incidence of breakthrough fungal infection (BFI) including proven, probable and possible fungal infection
- Conditions
- Invasive Fungal Disease, Graft Versus Host Disease, Hematopoietic Stem Cell Transplantation
- Being tested
- Posaconazole tablet
- Keywords
- hematopoietic stem cell transplantation, graft versus host disease, invasive fungal disease, primary prophylaxis
- Medical subject headings
- Invasive Fungal Infections, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posaconazole tabletDrug
Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined. Once patients developed GI GVHD, first line therapy and second line treatment will be reviewed according to the condition, besides which the Posaconazole plasma concentration would be detected again on the first, third and fifth day after onset of GI GVHD symptoms to monitor the impact of GI GVHD on the Posaconazole plasma concentration.
| Study group | Role | What they receive |
|---|---|---|
| Posaconazole tablet | Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined. Receives: Drug: Posaconazole tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary endpoint
- The incidence of breakthrough fungal infection (BFI) including proven, probable and possible fungal infection
Measured: From 7 days after starting posaconazole prophylaxis post-transplant to 7 days after the end of prophylaxis
Secondary outcomes (3)
2
Posaconazole plasma concentration
Measured: Day 5 after posaconazole administration, and Days 1, 3, and 7 after the onset of gastrointestinal GVHD
3
Gastrointestinal GVHD grade, diarrhea status (frequency, volume), use and adjustment of immunosuppressants, neutrophil count
Measured: From the first day of posaconazole prophylaxis for IFD post-transplant to the end of prophylaxis.
4
Adverse events
Measured: From the first day of posaconazole prophylaxis for IFD post-transplant to the end of prophylaxis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Aug 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal DiseaseStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 100 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aiming Pang, doctor, Principal investigator, Hematopoietic stem cell transplantation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698211
- Sponsor's protocol ID
- QTJC2024039
- Status last verified
- Nov 2024
- First submitted
- 23 Oct 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing is not considered for the time being due to patient privacy concerns.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Posaconazole Tablet As Primary Prophylaxis of Hematopoietic Stem Cell Transplant Patients with Gastrointestinal GVHD
- ClinicalTrials.gov ID
- NCT06698211
- Acronym / sponsor ID
- QTJC2024039
- Conditions
- Invasive Fungal Disease, Graft Versus Host Disease, Hematopoietic Stem Cell Transplantation
- Keywords
- hematopoietic stem cell transplantation, graft versus host disease, invasive fungal disease, primary prophylaxis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 20 Nov 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 investigation using a nonrandomized, single-arm design. Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined.
Detailed description
This is a prospective investigation using a nonrandomized, single-arm design. Posaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined. Once patients developed GI GVHD, first line therapy and second line treatment will be reviewed according to the condition, besides which the Posaconazole plasma concentration would be detected again on the first, third and fifth day after onset of GI GVHD symptoms to monitor the impact of GI GVHD on the Posaconazole plasma concentration. The primary endpoint was the incidence of breakthrough fungal infection (BFI) including proven, probable and possible fungal infection
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 100 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Posaconazole tablet | – | Drug: Posaconazole tabletPosaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patient undergoing Hematopoietic stem cell transplantation who meet the inclusion criteria and do not meet the exclusion criteria can enroll in this study. 2. Ages eligible for study: 18-75 3. Sexes eligible for study: All 4. Race: Chinese 5. Ethnicity: All
Key inclusion criteria (5 listed)
- Patients with hematologic diseases who undergoes hematopoietic stem cell transplantation.
- Patients who receive Posaconazole tablet as primary prophylaxis of invasive fungal disease.
- Patients developing or developed acute gastrointestinal GVHD which require systemic immunosuppressive therapy of corticosteroids with- or-without other immunosuppressive agents including calcineurin inhibitors.
- Gastrointestinal GVHD grades (I-IV) were recorded according to the Glucksberg criteria.
- Patients themselves or their authorized clients agree to participate in the clinical study and sign the informed consent
Key exclusion criteria (8 listed)
- refuse to enroll
- patients have known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study medication used.
- pregnant or lactating females
- take drugs known to interfere with azole antifungal agents, including terfenadine, cisapride and ebastine, within 24h before Posaconazole application; astemizole at enrollment or within 10 days before Posaconazole application; or cimetidine, rifampin, carbamazepine, phenytoin, rifamycin, barbiturates, isoniazid, catharanthine and anthracyclines within 24 h before Posaconazole application
- have an ECG with a prolonged QTc interval (QTc greater than 500 ms);
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 |
|---|---|---|
| Posaconazole tabletPosaconazole tablet will be given at a dose of 300mg q12h on day 1 and 300mg qd from day 2 for patients who receive HSCT as the primary prophylaxis of IFD, after which the Posaconazole plasma concentration on day 5 will be examined. Once patients developed GI GVHD, first line therapy and second line treatment will be reviewed according to the condition, besides which the Posaconazole plasma concentration would be detected again on the first, third and fifth day after onset of GI GVHD symptoms to monitor the impact of GI GVHD on the Posaconazole plasma concentration. | Drug | Posaconazole tablet |
Primary outcome
primary endpoint
Time frame: From 7 days after starting posaconazole prophylaxis post-transplant to 7 days after the end of prophylaxis
1. The incidence of breakthrough fungal infection (BFI) including proven, probable and possible fungal infection
3 secondary outcomes
2
Time frame: Day 5 after posaconazole administration, and Days 1, 3, and 7 after the onset of gastrointestinal GVHD
3
Time frame: From the first day of posaconazole prophylaxis for IFD post-transplant to the end of prophylaxis.
4
Time frame: From the first day of posaconazole prophylaxis for IFD post-transplant to the end of prophylaxis.
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 20 Nov 2024.
- Individual participant dataSharing planned: No. Data sharing is not considered for the time being due to patient privacy concerns.
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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.
Aiming Pang, doctor principal investigator
Hematopoietic stem cell transplantation Center
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 Invasive Fungal Disease and Graft Versus Host Disease, run by Institute of Hematology & Blood Diseases Hospital, China 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 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: enrolling by invitation, as of the sponsor's last update on 20 Nov 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.
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?
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?
primary endpoint (time frame: From 7 days after starting posaconazole prophylaxis post-transplant to 7 days after the end of prophylaxis). 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 20 Nov 2024.