Clinical trials: sponsored by Xiamen Amoytop Biotech Co., Ltd.
Non Small Cell Lung Cancer, Breast Cancer
Safety and Efficacy of YPEG-rhG-CSF in Cancer Patients Receiving Chemotherapy
This study is to examine which dose of YPEG-rhG-CSF, once-per-cycle, has similar efficacy and safety, comparing to PEG-rhG-CSF, once-per-cycle, in chemotherapy-induced neutropenia
- Trial name
- NCT02005458
- Testing
- YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle, YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle, YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
- Where
- 12 sites in China
- Volunteers
- 80 people
- Sponsor
- Xiamen Amoytop Biotech 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.
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.
Healthy
PK & PD Study of Pegylated rhEPO, and Evaluated Its Safety and Tolerability in Male Healthy Individual
The object of this randomized, parallel, positive controlled study is to explore the pharmacokinetics and pharmacodynamics profile of the test drug after single-dose subcutaneous administration, compared to the comparator drug…
- Trial name
- NCT01800305
- Testing
- Pegylated rhEPO, EPIAO®
- Where
- China
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Mycoses
Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT
We conducted a prospective, multicenter, open-label randomized trial to compare the antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF), Recombinant Human Granulocyte Stimulating Factor…
- Trial name
- NCT01232504
- Testing
- rhGM-CSF group, rhG-CSF+rhGM-CSF group, rhG-CSF group
- Where
- 5 sites in China
- Volunteers
- 206 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Chronic Hepatitis C
Efficacy and Safety Study of Peginterferon Alfa-2b in Chinese Chronic Hepatitis C Patients
The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b (40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of 180μg/week, in combination with Ribavirin in…
- Trial name
- NCT01581398
- Testing
- Ypeginterferon alfa-2b, Pegasys
- Where
- 42 sites in China
- Volunteers
- 770 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Chronic Hepatitis C
Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C
This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess the efficacy and safety of Ypeginterferon alfa-2b (with Ribavirin), once a week, in 3 dose-groups respectively, for…
- Trial name
- PEGIFN (NCT01140997)
- Testing
- Ypeginterferon alfa-2b, Peginterferon alfa-2a
- Where
- 38 sites in China
- Volunteers
- 211 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
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.
Chemotherapy Patients
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of YPEG-Filgrastim in Chemotherapy Patients
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish dose-response relationships between…
- Trial name
- Filgrastim (NCT01238562)
- Testing
- YPEG-Filgrastim
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Pegylated-Somatropin in Healthy Volunteers
This study is aimed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of Pegylated-Somatropin in healthy male volunteers, and collect scientific data for the design and conduct of subsequent…
- Trial name
- Somatropin (NCT01339182)
- Testing
- Pegylated-Somatropin, YPEG-Somatropin
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Healthy Subjects
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Assessment of Ypeginterferon Alfa-2a in Healthy Subjects
This study is aimed to study the pharmacokinetic characteristics(e.g. AUC, Cmax, Tmax) of Ypeginterferon alfa-2a and interferon biomarkers(e.g. 2,5-OAS, neopterin) after single dose at different levels.
- Trial name
- NCT01343186
- Testing
- Peginterferon alfa, Peginterferon alfa 2a, Peginterferon alfa-2a
- Where
- China
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.