An observational study in Invasive Fungal Disease, Graft Versus Host Disease and Hematopoietic Stem Cell Transplantation, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Observational
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Among 29 studies in Invasive Fungal Infections with a site in China — 12 open to participants now, 12 under way, none of them phase 3. Invasive Fungal Infections · China.
Among the 29 studies in Invasive Fungal Infections with a site in China, this one is the 12th largest by planned enrollment of the 17 observational ones that give a count, is one of 2 that started in 2023, is one of 17 observational ones, reaches primary completion later than 1 of the 11 other live ones, and was the 16th registered.
136 studies on the registry are indexed under Invasive Fungal Infections; 33 are open to participants now.
Browse Invasive Fungal Infections studies →12 of the 29 studies in Invasive Fungal Infections with a site in China are open now. Recruiting first, the newest first:
Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Sites in China
Ages 3–17
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 1 mo–18 yrs
Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Sites in China
Ages 18–75
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 18+
Peking University People's Hospital · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 20 Invasive Fungal Infections studies recruiting now, 12 (60%) set no upper age limit and 5 (25%) stop at 75 or younger; 9 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
29 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 125 across 66 observational studies indexed under Invasive Fungal Infections.
Median enrollment 74 across the 12 interventional studies, 120 across the 17 observational. Of the 13 that completed or were terminated, 3 (23%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 29 have an industry lead sponsor. The 10 most frequent:
Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 413 studies on the registry; 292 are open to participants now.
Institute of Hematology & Blood Diseases Hospital, China has 4 studies filed under Invasive Fungal Infections — fewer than ten, so there is no comparison to draw.
4 of the studies in Invasive Fungal Infections with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07135778Institute of Hematology & Blood Diseases Hospital, ChinaLiposomal Amphotericin B and Isavuconazole/Posaconazole in Br-IFD（ Breakthrough Invasive Fungal Disease） in Patients With Malignant Hematological Diseases | 2026-12-31 |
| NCT07725263Haikou Affiliated Hospital of Central South University Xiangya School of MedicineLow-Dose Liposomal Amphotericin B for Invasive Fungal Infection Prophylaxis in Neutropenic Children | 2027-02-28 |
| NCT07357038Institute of Hematology & Blood Diseases Hospital, ChinaA Real-world Prospective Observational Study on the Efficacy and Safety of L-AmB(Liposomal Amphotericin B) for br- IFD(Breakthrough Invasive Fungal Disease) in Children and Adolescent Patients With Hematological Malignancies Receiving Triazoles or Echinocandins Prophylaxis | 2027-02-28 |
| NCT07763184Nanfang Hospital, Southern Medical UniversitymNGS for IFD in Patients With Hematological Malignancies | 2027-09-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 29 studies in Invasive Fungal Infections with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients developing or developed acute gastrointestinal which require systemic therapy of with- or-without other immunosuppressive agents including calcineurin inhibitors.
Gastrointestinal GVHD grades (I-IV) were recorded according to the Glucksberg criteria.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: 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. 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.
primary endpoint
1. The incidence of breakthrough fungal infection (BFI) including proven, probable and possible fungal infection
Time frame: From 7 days after starting posaconazole prophylaxis post-transplant to 7 days after the end of prophylaxis
2
Posaconazole plasma concentration
Time frame: 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
Time frame: From the first day of posaconazole prophylaxis for IFD post-transplant to the end of prophylaxis.
4
Adverse events
Time frame: From the first day of posaconazole prophylaxis for IFD post-transplant to the end of prophylaxis.
Plan to share: No — Data sharing is not considered for the time being due to patient privacy concerns.
No publications or documents are linked to this record.
Started Aug 2023 (actual). Primary completion is estimated for Dec 2024, 16 months after the start.
Of 30 observational studies under Invasive Fungal Infections, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 57. This study's planned 16 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Institute of Hematology & Blood Diseases Hospital, China →