Clinical trials: sponsored by Peking University First Hospital
Metastatic Breast Cancer
Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer
This study is a multi-center, open-label, dose-esclation I/Ib clinical study to explore safety, efficacy an pharmacokinetics of proxalutamide in patients with metastatic breast cancer.
- Trial name
- NCT04103853
- Testing
- Proxalutamide
- Where
- 7 sites in China
- Volunteers
- 63 people
- Sponsor
- Suzhou Kintor Pharmaceutical Inc,
Hepatitis B
Long-term Benefit in Chronic Hepatitis B Patients After Standard Peginterferon Alfa Therapy
In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN study and received at least 39 doses of peginterferon alfa will be enrolled.
- Trial name
- NCT03181113
- Testing
- Peginterferon Alfa-2B, Peginterferon Alfa-2A
- Where
- 28 sites in China
- Volunteers
- 473 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Advanced HBV-Related Hepatocellular Carcinoma (HCC)
The Phase III Study of Icaritin Versus HUACHANSU PIAN in Hepatocellular Carcinoma Subjects
The enriched HBV-related advanced HCC patient population (composite biomarker score ≥ 2) and overall survival (OS) were compared between the two groups.
- Trial name
- NCT03236636
- Testing
- Icaritin, HUACHANSU PIAN
- Where
- 28 sites in China
- Volunteers
- 312 people
- Sponsor
- Beijing Shenogen Biomedical Co., Ltd
Myocardial Reperfusion Injury
Efficacy and Safety Evaluation of PC-SOD for Injection in Reducing Myocardial Reperfusion Injury
The current study aims to evaluate different doses of PC-SOD injections for efficacy and safety in comparison to placebo, in order to provide a basis for future clinical trials in terms of experimental design and dose selection.
- Trial name
- NCT03995732
- Testing
- PC-SOD
- Where
- 2 sites in China
- Volunteers
- 120 people
- Sponsor
- Beijing Tide Pharmaceutical Co., Ltd
Ventricular Tachycardia, Ventricular Fibrillation
Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection
Retrospective and Prospective single arm, observational study to evaluate efficacy and safety of NIF in the treatment of ventricular tachycardia and ventricular fibrillation.
- Trial name
- NCT03853369
- Testing
- Nifekalant hydrochloride
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Dwarfism
A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Short Stature Children Due to Chronic Kidney Disease Before Transplantation
This study aims to evaluate the efficacy and safety of recombinant human growth hormone injection in short stature children due to chronic kidney disease before transplantation.
- Trial name
- NCT03535415
- Testing
- Recombinant Human Growth Hormone Injection (rhGH)
- Where
- 12 sites in China
- Volunteers
- 68 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Hypertension
H-Type Hypertension Precision Medicine Trial
This is a multicenter, randomized, double-blind, controlled clinical trial. It aims to investigate the effects of different doses of folic acid on lowering homocysteine (Hcy) in patients with hypertension with different genotypes…
- Trial name
- NCT03472508
- Testing
- Folic Acid, Enalapril Maleate and Folic Acid Tablets (Yiye), Enalapril
- Where
- 5 sites in China
- Volunteers
- 3,600 people
- Sponsor
- Shenzhen Ausa Pharmed Co.,Ltd
Prader-Willi Syndrome
A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi Syndrome
To evaluate the effectiveness of rhGH (Recombinant human growth hormone) injection for improving motor development in patients with PWS.
- Trial name
- NCT03554031
- Testing
- Recombinant Human Growth Hormone (rhGH) Injection
- Where
- 6 sites in China
- Volunteers
- 30 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Pancreatitis
Ulinastatin in Severe Acute Pancreatitis
This study aims to evaluate the effect of ulinastatin in the treatment and prevention of organ failure in severe acute pancreatitis.
- Trial name
- NCT01132521
- Testing
- ulinastatin
- Where
- 6 sites in China
- Volunteers
- 252 people
- Sponsor
- Techpool Bio-Pharma Co., Ltd.
Growth Hormone Deficiency
Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency
To Evaluate the safety and efficacy of PEG Somatropin in the treatment of children with growth hormone deficiency, as well as to study the dosage of PEG Somatropin.
- Trial name
- NCT03249480
- Testing
- PEG-somatropin
- Where
- 28 sites in China
- Volunteers
- 900 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Adult Growth Hormone Deficiency
A Non-inferiority Phase 2 Study to Evaluate the Safety and Efficacy of PEG-rhGH in the Treatment of AGHD
This study aims to explore the optimal dose of PEG-rhGH injection in the treatment of AGHD, preliminarily evaluate its safety and efficacy, to provide scientific and reliable evidence for the medication dosage in Phase 2 clinical…
- Trial name
- NCT03104010
- Testing
- Somatropin Injection
- Where
- 9 sites in China
- Volunteers
- 180 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Ovarian Hyperstimulation Syndrome
Clinical Study of Recombinant Human Follitropin for Injection Assisted in COH Assisted IVF-ET
The aim of this study was to evaluate the efficacy and safety of domestic recombinant human follicle stimulating hormone (rhFSH) stimulating ovarian to promote follicular development before assisted reproductive technology, which…
- Trial name
- NCT03071172
- Testing
- Triptorelin for Injection, Recombinant Human Choriogonadotropin alfa Solution for Injection, Progesterone Soft Capsules
- Where
- 7 sites in China
- Volunteers
- 252 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Chronic Hepatitis B
A Prospective Study of Combination of Peginterferon Alfa-2b (40kD, Y-shape) and GM-CSF in Chronic Hepatitis B
This study is a multi-center, randomized, prospective open-label study to assess the efficacy and safety of combination of peginterferon alfa-2b (40kD, Y-shape) and GM-CSF in interferon-naïve chronic hepatitis B patients with…
- Trial name
- NCT02332473
- Testing
- Ypeginterferon alfa-2b, Granulocyte-macrophage colony stimulating factor
- Where
- 12 sites in China
- Volunteers
- 110 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Neutropenia
Saftey and Efficacy of Pegfilgrastim in Preventing Chrmotherapy-induced Neutropenia
This study will assess the Efficacy and Safety of different doses of PEG-rhG-CSF and a single-dose of G-CSF in Preventing Chemotherapy-induced Neutropenia.
- Trial name
- PEG-rhG-CSF (NCT01918241)
- Testing
- pegfilgrastim,30mcg/kg, pegfilgrastim, 60mcg/kg, pegfilgrastim, 100mcg/kg
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Chronic Hepatitis B
Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
This study is aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD, Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient evidences for the listed of the studied drug.
- Trial name
- NCT01760122
- Testing
- Ypeginterferon alfa-2b, Pegasys
- Where
- 43 sites in China
- Volunteers
- 820 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Anovulation
Phase III Clinical Study of Domestic Recombinant Human Follitropin for Injection to Treat WHO Class II Anovulation
The purpose of this study is to evaluate the efficacy and safety of Domestic Recombinant Human Follitropin (Gonal-F) for Injection for treatment of WHO Ⅱ anovulation (including polycystic ovarian syndrome [PCOS] subjects).
- Trial name
- NCT02335879
- Testing
- Gonal-F
- Volunteers
- 534 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Essential Hypertension
Efficacy of Amlodipine-folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine
To evaluate the efficacy of Amlodipine-folic Acid Tablets on reduction of blood pressure and plasma homocystein.
- Trial name
- NCT01848873
- Testing
- Amlodipine, amlodipine-FA tablet, low dose group, amlodipine-FA tablet ,high dose group
- Where
- 16 sites in China
- Volunteers
- 756 people
- Sponsor
- Shenzhen Ausa Pharmed Co.,Ltd
Anemia in End Stage Renal Disease
Study of FG-4592 in Subjects With End-Stage Renal Disease Receiving Maintenance Hemodialysis in China
The purpose of this study is to evaluate the efficacy and safety of FG-4592 in maintaining and/or correcting hemoglobin (Hb) given to subjects with End Stage Renal Disease (ESRD) on maintenance hemodialysis and receiving epoetin…
- Trial name
- NCT01596855
- Testing
- FG-4592, Epoetin Alfa
- Where
- 9 sites in China
- Volunteers
- 96 people
- Sponsor
- Kyntra Bio
Chronic Hepatitis B
Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3 dose-groups: 90mcg, 135mcg and 180mcg, respectively…
- Trial name
- NCT01143662
- Testing
- Ypeginterferon alfa-2b, Peginterferon alfa-2a
- Where
- 39 sites in China
- Volunteers
- 205 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Type 2 Diabetes
The Safety,Preliminary Pharmacodynamics and Pharmacokinetics Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus
This research is randomized, controlled trial. 36 Chinese subjects with Type 2 Diabetes Mellitus will take part in the trial. Subjects will randomly enter into one of three groups, administration daily twice, the period of is 84…
- Trial name
- SPPS (NCT01342042)
- Testing
- rExenatide-4
- Where
- China
- Volunteers
- 36 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.