Clinical trials: sponsored by Peking University First Hospital
Adverse Drug Reaction, Cinepazide
Post-Marketing Surveillance of the Cinepazide Maleate Injection: a Real World Study
Cinepazide Maleate Injection is widely used in cerebrovascular disease in china. The safety of the cinepazide, especially the blood system, has not been fully evaluated in Chinese population.
- Conditions
- Adverse Drug Reaction, Cinepazide, Stroke
- Trial name
- PACER (NCT01946919)
- Where
- 61 sites in China
- Volunteers
- 18,260 people
- Sponsor
- Peking University Third Hospital
Moyamoya Disease, Moyamoya Syndrome
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
This multicenter prospective observational cohort study aims to develop and validate individualized risk prediction models for stroke and cognitive decline in patients with moyamoya disease or moyamoya syndrome by integrating…
- Trial name
- NCT07894107
- Where
- 13 sites in China
- Volunteers
- 3,000 people
- Sponsor
- Beijing Tiantan Hospital
Prostate Cancer
Non-inferiority Trial Omitting Drainage After Robot-assisted Radical prostatectomY
This is a multicenter, prospective, randomized, controlled, open-label, assessor-blinded, non-inferiority trial evaluating whether pelvic drainage can be safely omitted after robot-assisted radical prostatectomy (RARP).
- Trial name
- POND-RARP (NCT07887321)
- Testing
- No Pelvic Drain Placement, Pelvic Drain Placement
- Where
- 3 sites in China
- Volunteers
- 400 people
- Sponsor
- Shanghai East Hospital
Limb Girdle Muscular Dystrophy Type 2D/R3
BBM-L101 Gene Therapy in Participants With LGMD2D/R3
This phase 1 study will evaluate a single intravenous infusion of BBM-L101, an investigational AAV-based gene therapy designed to deliver a functional SGCA gene, in ambulatory children aged 4 to <13 years with genetically…
- Trial name
- NCT07874516
- Testing
- BBM-L101 Injection
- Where
- China
- Volunteers
- 8 people
- Sponsor
- Peking University First Hospital
Multiple Myeloma, Amyloidosis
A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH
The primary aim is to establish a prospective cohort of patients with plasma cell disorders (PCDs). All of the hospitalized PCD patients who are willing to sign the informed consent form (ICF) will be included in this study.
- Conditions
- Multiple Myeloma, Amyloidosis, Cryoglobulinemia, Castleman's Disease
- Trial name
- NCT05283993
- Testing
- No intervention
- Where
- China
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Peking University First Hospital
Hematopoietic Stem Cell Transplantation (HSCT), cGVHD
Belumosudil Versus Ruxolitinib for Steroid-Refractory or Breakthrough Hepatic cGVHD
This prospective, randomized, open-label, multicenter trial aims to compare second-line treatment strategies for hepatic cGVHD after allo-HSCT.
- Conditions
- Hematopoietic Stem Cell Transplantation (HSCT), cGVHD, Hepatic cGVHD, Belumosudil
- Trial name
- NCT07794514
- Testing
- Ruxolitinib treatment, Belumosudil treatment, Belumosudil Switch to Ruxolitinib
- Where
- China
- Volunteers
- 170 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Thrombotic Microangiopathy, Hematopoietic Stem Cell Transplantation (HSCT)
Safety and Efficacy of Iptacopan in Patients With High-Risk Transplantation-Associated Thrombotic Microangiopathy
The goal of this clinical trial is to evaluate the efficacy and safety of Iptacopan as a second-line treatment for high-risk hematopoietic stem cell transplantation-associated thrombotic microangiopathy (TA-TMA).
- Trial name
- NCT07347990
- Testing
- iptacopan
- Where
- China
- Volunteers
- 30 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Osteosarcoma, Osteosarcoma, Recurrent, Refractory
68Ga-B7-H3 Nanobody ImmunoPET in Osteosarcoma
This study aims to evaluate the safety, feasibility, and imaging performance of a novel 68Ga-labeled B7-H3 nanobody for immunoPET imaging in patients with osteosarcoma.
- Trial name
- NCT07774533
- Testing
- 68Ga-B7-H3 Nanobody PET/CT
- Where
- China
- Volunteers
- 16 people
- Sponsor
- Peking University First Hospital
Focal Epilepsy, Intraoperative Monitoring
High-density Flexible μECoG for Epilepsy Surgery - A Single-Arm ECT
What's the clinical value of high-density flexible microelectrocorticography (μECoG) for guiding the resection of epileptogenic zone (EZ) in epilepsy surgery?
- Trial name
- Epi-PRECISE (NCT07656857)
- Testing
- Using High-density Flexible microElectrocorticography for intraoperative monitoring
- Where
- China
- Volunteers
- 85 people
- Sponsor
- Beijing Tiantan Hospital
Intrapartum Maternal Fever, Clinical Chorioamnionitis
Association Between Neuraxial Labor Analgesia and Maternal and Neonatal Infectious Outcomes
The goal of this retrospective observational cohort study is to explore the associations between neuraxial labor analgesia and maternal-neonatal infectious outcomes among women attempting vaginal delivery, and to distinguish…
- Conditions
- Intrapartum Maternal Fever, Clinical Chorioamnionitis, Neonatal Infection
- Trial name
- NCT07751666
- Testing
- neuraxial labor analgesia
- Volunteers
- 49,000 people
- Sponsor
- Peking University First Hospital
Intracranial Aneurysm
Intelligent Microcatheter Shaping for Intracranial Aneurysm Coil Embolization
This prospective, multicenter, observational registry study will evaluate the real-world safety, effectiveness, and clinical value of artificial intelligence (AI)-assisted microcatheter shaping during coil embolization of…
- Trial name
- NCT07749404
- Testing
- Physician-Experience Microcatheter Shaping, AI-Assisted Microcatheter Shaping Simulation Technology
- Where
- China
- Volunteers
- 1,438 people
- Sponsor
- Xuanwu Hospital, Beijing
Phelan-McDermid Syndrome, SHANK3 Haploinsufficiency
RB001 Gene Therapy Study in Children With SHANK3-related Phelan-McDermid Syndrome (PMS)
This is an open-label, dose-escalation study to evaluate the safety, tolerability, and clinical activity of a single dose of RB001 administered via intracerebroventricular (ICV) injection in pediatric with SHANK3 related…
- Trial name
- NCT07014020
- Testing
- RB001
- Where
- China
- Volunteers
- 8 people
- Sponsor
- Peking University First Hospital
Pregnancy Complication, Aortic Dissection
PregnAncy-Related Aortic DISsEction in China
A multicenter observational study on pregnancy-related aortic dissection
- Conditions
- Pregnancy Complication, Aortic Dissection, Marfan Syndrome, Loeys-Dietz Syndrome
- Trial name
- PARADISE (NCT07672210)
- Testing
- Intervention strategies including medication or surgery
- Where
- 4 sites in China
- Volunteers
- 500 people
- Sponsor
- DeltaHealth Hospital · Shanghai
SHANK3 Haploinsufficiency, Phelan-McDermid Syndrome
Long-Term Follow-Up Study for RB001 Gene Therapy Study in Children With SHANK3-related Phelan McDermid Syndrome (PMS)
This is a long-term follow-up study of participants in the RB001-101 gene replacement therapy clinical trial for Children With SHANK3-related Phelan-McDermid Syndrome (PMS).
- Trial name
- RB001-101-LTFU (NCT07690527)
- Testing
- RB001
- Where
- China
- Volunteers
- 8 people
- Sponsor
- Peking University First Hospital
Peritoneal Dialysis
Predicting Peritoneal Kt/Vurea Based on Single-Exchange Dialysate Effluent
Background: Peritoneal dialysis (PD) adequacy is routinely evaluated using the urea clearance index (Kt/Vurea), a key indicator of small-solute clearance and treatment adequacy.
- Trial name
- NCT07659067
- Testing
- Single-Exchange Dialysate Effluent-Based Prediction of Peritoneal Kt/Vurea
- Volunteers
- 300 people
- Sponsor
- Peking University First Hospital
Perioperative/Postoperative Complications, Anaphylaxis
Diagnosis and Allergen Identification of Perioperative Anaphylaxis
Perioperative anaphylaxis may lead to fatal respiratory and/or circulatory events, yet both clinical diagnosis and management are challenging.
- Conditions
- Perioperative/Postoperative Complications, Anaphylaxis, Tryptase, Allergens
- Trial name
- NCT06793163
- Where
- 6 sites in China
- Volunteers
- 115 people
- Sponsor
- Peking University First Hospital
Hematopoietic Stem Cell Transplantation
Individualized Application of Anti-Thymocyte Globulin(ATG)in Unrelated Donor Hematopoietic Stem Cell Transplantation
This study aims to compare individualized anti-thymocyte globulin (ATG) dosing versus conventional fixed-dose regimens in unrelated donor peripheral blood stem cell transplantation (URD-PBSCT).
- Trial name
- NCT07648992
- Testing
- Anti-Thymocyte Globulin
- Where
- China
- Volunteers
- 324 people
- Sponsor
- Daihong Liu
HBV Reactivation, HSCT
HBV Reactivation Prediction Model in Allo-HSCT
Hepatitis B virus (HBV) reactivation is a serious complication after allogeneic haematopoietic stem cell transplantation (allo-HSCT), particularly in patients with resolved HBV infection (HBsAg-negative, anti-HBc-positive).
- Trial name
- HBV-post HSCT (NCT07644026)
- Testing
- No Intervention: Observational Cohort
- Volunteers
- 300 people
- Sponsor
- Xiao Hui Zhang
Intracranial Aneurysm
Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment
We designed the Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment (WEB-RWS), an ambidirectional, multicenter, post-market real-world study with a prospective active surveillance component.
- Trial name
- WEB-RWS (NCT07620626)
- Testing
- Intrasaccular Flow Disruption Device
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Xuanwu Hospital, Beijing
Phyllodes Breast Tumor, Prognosis
Breast Phyllodes Tumors: Based on 20-year Real-world Data From China
Phyllodes tumor (PT) is a rare type of breast tumor made up of both connective tissue (stroma) and gland tissue (epithelium). It accounts for less than 1% of all breast tumors. The main symptom is a fast-growing, painless lump.
- Trial name
- NCT07636096
- Where
- China
- Volunteers
- 3,500 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University