scholarly journals Efficacy and safety of flexibly dosed paliperidone palmitate in Chinese patients with acute schizophrenia: an open-label, single-arm, prospective, interventional study

2015 ◽  
pp. 1483
Author(s):  
Yu Feng ◽  
Tianmei Si ◽  
Kerang Zhang ◽  
Jisheng Tang ◽  
Maosheng Fang ◽  
...  
Keyword(s):  
Chinese Patients ◽  
Paliperidone Palmitate ◽  
Efficacy And Safety ◽  
Interventional Study ◽  
Open Label ◽  
Acute Schizophrenia

Preliminary results of a phase II trial of FOLFOX4 regimen in Chinese patients with unresectable primary liver cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14065-14065 ◽  
Author(s):  
S. K. Qin ◽  
Y. J. Wang ◽  
Q. Wu ◽  
B. C. Xing
Keyword(s):  
Hepatocellular Carcinoma ◽  
Liver Cancer ◽  
Phase Ii ◽  
Primary Liver Cancer ◽  
Safety Data ◽  
Median Number ◽  
Chinese Patients ◽  
Efficacy And Safety ◽  
Open Label ◽  
Number Of Cycles

14065 Background: Primary liver cancer (PLC) is the 3rd most common cancer in whole China. Development of systemic chemotherapy for the patients not eligible for operation as well as TACE commonly have been required. Oxalipaltin (Eloxatin)+ 5-FU/LV, namely FOLFOX 4 regimen was tried to investigate its efficacy and safety in inoperable PLC. Methods: It was an open-label, single arm and multi-center phase II study to explore RR, DCR,TTP and MST. All the pts had pathologically confirmed inoperable PLC with/without distant metastasis. The pts were treated with the standard FOLFOX 4 regimen, that is OXA 85mg/m2 d1; LV 200mg/m2 IV 2hrs d1,2; 5-FU 400mg/m2 bolus, d1,2 and 5-FU 600mg/m2 CIV 22hrs d1,2; q2w upto 6 cycles or until progression. Tumor evaluation was done every 6 weeks using RECIST criteria. Neurotoxicity was evaluated by Eloxatin specific neurotoxicity criteria (Sanofi-Aventis Co.Ltd) and other toxicities by the NCI CTC AE version 2.0. Results: From July 2004 to Sep. 2005, 27 pts (21 male, 6 female) were recruited from the 4 cancer centers with average age of 56 ±13 years old. 25 patients (92.6%) had hepatocellular carcinoma, and 2 (7.4%) cholangiocellular carcinoma. 15 pts (55.6%) had metastatic disease. 1 pt received liver transplantation before inclusion. The median number of cycles was 4 per pt. 26 pts were evaluable for efficacy and safety. The RR was 19.2% (5/26; 1 CR and 4 PR), and DCR 57.7% (15/26; including 10 SD). 4 of the 5 responsive pts had hepatocellular carcinoma, and 1 had cholangiocarcinoma. Serum AFP level was significantly decreased (mean 131,890.4ug/dl at the baseline and 1,298.6ug/dl after 6 cycles) for the first 16 pts. The first 16 pts’ safety data were available in detail: 11 NCI grade 3/4 events were observed from a total of 76 cycles administered: including 5 neutropenia, 3 leucopenia, 1 thrombocytopenia, 1 infection and 1 liver dysfunction. Grade II & III neurotoxicity was found in 3 & 2 patients respectively. The TTP,MST and further safety data were under follow-up. Conclusions: The preliminary data of the FOLFOX 4 regimen for the advanced Chinese pts with inoperable PLC have shown encouraging results with the better efficacy and favorable safety profile. Further exploration in this area is warranted, especially in hepatocellular carcinoma. No significant financial relationships to disclose.

scholarly journals Efficacy and safety of lanreotide autogel compared with lanreotide 40 mg prolonged release in Chinese patients with active acromegaly: Results from a phase 3, prospective, randomized, and open-label study (LANTERN)

2020 ◽  
Author(s):  
Zhenmei An ◽  
Ting Lei ◽  
Lian Duan ◽  
Pei Hu ◽  
Zhongping Gou ◽  
...  
Keyword(s):  
Chinese Patients ◽  
Prolonged Release ◽  
Efficacy And Safety ◽  
Open Label ◽  
Phase 3 ◽  
Treatment Groups ◽  
Intention To Treat ◽  
Secondary Endpoints ◽  
Active Acromegaly ◽  
Lanreotide Autogel

Abstract Background: Lanreotide autogel is a somatostatin analog (SSA) approved for the treatment of acromegaly in 73 countries worldwide; however, it is not yet approved in China. The aim of this study was to evaluate the efficacy and safety of lanreotide autogel compared with lanreotide 40 mg prolonged release (PR) in Chinese patients with active acromegaly. Methods: LANTERN was a Phase 3, randomized, open-label, non-inferiority study. Patients with active acromegaly who had undergone surgery ≥3 months prior, or were unlikely or unable to undergo surgery, were treated with lanreotide autogel 60/90/120 mg (monthly deep subcutaneous injection) or lanreotide 40 mg PR (intramuscular injection every 7, 10, or 14 days) for 32 weeks. Primary endpoint was mean change-from-baseline in age-adjusted insulin-like growth factor-1 (IGF-1) standard deviations scores (SDS) at the end-of-study. Secondary endpoints included: growth hormone (GH) levels ≤2.5 µg/L or ≤1.0 µg/L, ≥20% reduction in tumor volume (TV) and safety. Results: In total, 128 patients were randomized and received study treatment. Lanreotide autogel was non-inferior to lanreotide 40 mg PR: treatment difference (95% CI) for IGF-1 SDS between groups was −0.32 (−0.74, 0.11; per protocol population) and −0.27 (−0.63, 0.09; intention-to-treat [ITT] population), respectively. Reductions in IGF-1 (−6.453 vs −7.003) and GH levels (−9.548 µg/L vs −13.182 µg/L), and the proportion of patients with ≥1 acromegaly symptom (−20.3% vs −32.5%) were observed from baseline to end-of-study in lanreotide autogel and lanreotide 40 mg PR groups, respectively. In the lanreotide autogel group, 45.5% (25/55) patients achieved ≥20% reduction in TV compared with 50.9% (25/53) in lanreotide 40 mg PR group (ITT). Safety profiles were similar in both treatment groups. Conclusions: Lanreotide autogel was non-inferior to lanreotide 40 mg PR in Chinese patients with active acromegaly after 32 weeks of treatment.

scholarly journals An Open label prospective interventional study to assess the prophylactic effect of Guduchi Ghan Vati in COVID-19: A community-based study in a containment zone of Himachal Pradesh, India

2021 ◽  
Author(s):  
Vyas Kavita ◽  
Chandla Anubha ◽  
Nariyal Vikas ◽  
Babita Yadav ◽  
Azeem Ahmed ◽  
...  
Keyword(s):  
Well Being ◽  
Himachal Pradesh ◽  
Tinospora Cordifolia ◽  
Efficacy And Safety ◽  
Interventional Study ◽  
Open Label ◽  
Epidemic Disease ◽  
Community Based ◽  
Prophylactic Measure ◽  
Related Data

Background: Outbreak of SARS-CoV-2 is Janapadoddhwamsa Vikara (epidemic disease) in Ayurveda, where Rasayana drugs (immunomodulators or rejuvenating therapy) have been advocated for controlling the diseases. Therefore, Guduchi Ghan Vati, containing a drug Guduchi (Tinospora cordifolia), a plant is selected for prevention of COVID-19. Objectives: To know the efficacy and safety of Ayurvedic intervention i.e. Guduchi Ghan Vati in prevention of COVID-19 infection among the community of containment areas. Methods: It is an open label, prospective, non-randomized, community based interventional study, carried out from 06 May to 23 June, 2020, in a containment zone Bijhari area of District Hamirpur of Himachal Pradesh, India. Guduchi Ghan Vati was provided to the community in dose of 500 mg twice a day with luke warm water on empty stomach for 30 days. Their demographic and health related data and Follow up of the same subjects was done on the 30th day through telephonic interviews using the E-format (google forms). Results: Total 1165 participants’ data were analysed to assess the efficacy and safety of Guduchi Ghan Vati. In the sample 85.2 % participants had no systemic disorders whereas 13.8 % participants were taking concomitant medicines for other morbidities. Incidence of COVID-19 positive cases was only 0.1% (n=01). Conclusion: Ayurvedic intervention (Guduchi Ghan Vati) was found to be safe and effective as a prophylactic measure for COVID-19 infection. This intervention was helpful in improving physical and psychological well-being with minimal adverse drug Reaction/Adverse Effect.

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