A Clinical Study to Evaluate the Long-Term Safety Sodium Oligomannate Capsules (GV-971)
- Conditions
- Alzheimer Disease
- Interventions
- Registration Number
- NCT05058040
- Lead Sponsor
- Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
- Brief Summary
A clinical study to evaluate the long-term safety of Sodium Oligomannate Capsules (GV-971)
- Detailed Description
Sodium oligomannate (Code: GV-971), a marine-derived oligosaccharide after extraction, separation and degradation from algae, can play a role in the treatment of Alzheimer's disease by reconditioning the dysbiosis of gut microbiota, preventing peripheral immune cells from invading the brain, inhibiting the inflammatory response in the brain, and targeting protein folding errors in the brain tissue. Phase I clinical study shows GV-971 was safe and tolerated in healthy adult volunteers when administered continuously at 1200 mg/dose or 1500 mg/day (750 mg/dose, bid) for 5 days. Phase II and III clinical studies show that the treatment of GV-971 at 900 mg/day dosage for 36 weeks can significantly improve the cognitive function of patients with mild to moderate Alzheimer's disease (AD) and was safe and well-tolerated.
Sodium Oligomannate Capsules obtained approval from China's National Medical Products Administration (NMPA) on November 2, 2019, with approval letter number of 2019S00571. This product is a chemical drug with a registration classification of 1.2. It is approved for the clinical indication of mild to moderate Alzheimer's disease and the function of improving the cognitive function of patients. The clinical dosage and administration is 3 capsules (450 mg)/time, bid, po.
Due to the limited number of subjects and observation period of medication in completed GV-971 clinical studies, and the screening of patients with the strict inclusion and exclusion criteria, the adverse reactions and long-term safety of GV-971 cannot be comprehensively observed and recorded. Therefore, according to the requirements of the NMPA for the marketing of new drugs, this study is intended to further carry out a post-marketing investigation on expanded population using a design of a 96-week intensive monitoring clinical trial to determine the incidence of known adverse reactions of GV-971 under long-term administration, observe the occurrence of new adverse reactions, analyze the correlation, incidence, severity, and risk factors of adverse reactions/events, and better guide the rational use of drugs in clinical practice.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2500
-
Subjects eligible for this study must meet all of the following criteria:
- ≥18 years of age;
- Signed informed consent form;
- Patients receiving GV-971 treatment prescribed by clinicians;
-
A subject may be excluded from participation in the study if any of the following apply:
- Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator;
- Female participants who are pregnant or lactating;
- Patients who cannot cooperate to complete the follow-up inquiries;
- Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GV-971 Sodium Oligomannate Capsules The recommended dose regimen for subjects: GV-971 450 mg (3 capsules) per dose, bid, po. in morning and evening
- Primary Outcome Measures
Name Time Method Long-term safety of GV-971 in clinical practice during 48 weeks Week 48 The incidence of adverse reactions and AE/SAE in patients treated with GV-971 during the 48-week monitoring period
Long-term safety of GV-971 in clinical practice during 96 weeks Week 96 The incidence of adverse reactions and AE/SAE in patients treated with GV-971 during the 96-week monitoring period
- Secondary Outcome Measures
Name Time Method Safety Endpoints: Vital signs, laboratory tests , electrocardiogram, and early withdrawal from the study during 96 weeks 96-week The incidence of adverse events and adverse reactions in patients with liver insufficiency and renal insufficiency receiving GV-971 during 96 weeks
Safety Endpoints: Vital signs, laboratory tests , electrocardiogram, and early withdrawal from the study during 48 weeks 48-week The incidence of adverse events and adverse reactions in patients with liver insufficiency and renal insufficiency receiving GV-971 during 48 weeks
Related Research Topics
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Trial Locations
- Locations (63)
Shenzhen Second People's Hospital (The First Affiliated Hospital of Shenzhen University)
🇨🇳Shenzhen, Guangdong, China
Guihang Guiyang Hospital
🇨🇳Guiyang, Guizhou, China
The First Affiliated Hospital of Guizhou University of Chinese Medicine
🇨🇳Guiyang, Guizhou, China
Wuhan Mental Health Center
🇨🇳Wuhan, Hubei, China
Lianyungang Chinese Medicine Hospital
🇨🇳Lianyungang, Jiangsu, China
Suzhou Guangji Hospital
🇨🇳Suzhou, Jiangsu, China
Suzhou Municipal Hospital(Geriatrics)
🇨🇳Suzhou, Jiangsu, China
Jinan Central Hospital Affiliated To Shandong University
🇨🇳Jinan, Shandong, China
Shandong Mental Health Center
🇨🇳Jinan, Shandong, China
Huashan Hospital affiliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China
Second hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China
Shanghai Fengxian District Central Hospital
🇨🇳Shanghai, Shanghai, China
Shanxi Provincial People's Hospital
🇨🇳Xi'an, Shanxi, China
The Fifth People's Hospital of Chengdu
🇨🇳Chengdu, Sichuang, China
Nanchong Central Hospital
🇨🇳Nanchong, Sichuang, China
Chengdu Eighth People's Hospital
🇨🇳Chengdu, Sichuan, China
Sichuan Baoshihua Hospital
🇨🇳Chengdu, Sichuan, China
Huzhou Third Municipal Hospital
🇨🇳Huzhou, Zhejiang, China
Wenzhou People's Hospital
🇨🇳Wenzhou, Zhejiang, China
Dongguan People's Hospital
🇨🇳Dongguan, Guangdong, China
Zhuhai People's Hospital
🇨🇳Zhuhai, Guangdong, China
Beijing Bo'ai Hospital
🇨🇳Beijing, Beijing, China
Sanbo Brain Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
The Third Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Beijing Geriatric Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of USTC(Anhui Provincial Hospital)
🇨🇳Hefei, Anhui, China
Xi 'an Baoshihua Changqing Hospital
🇨🇳Xi'an, Shanxi, China
Chengdu Fourth People's Hospital
🇨🇳Chengdu, Sichuang, China
Sichuan Academy of Medical Sciences sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
Tong Ren Hospital,Shanghai Jiao Tong University School Of Medicine
🇨🇳Shanghai, Shanghai, China
Xiamen Xianyue Hospital
🇨🇳Xianmen, Fujian, China
Chongqing 11th People's Hospital (Chongqing Special Care Hospital)
🇨🇳Chongqing, Chongqing, China
Shenzhen Luohu District People's Hospital
🇨🇳Shenzhen, Guangdong, China
Taizhou Second People's Hospital
🇨🇳Taizhou, Jiangsu, China
Zhenjiang mental health center
🇨🇳Zhenjiang, Jiangsu, China
The Second Affiliated Hospital of Guizhou University of Chinese Medicine
🇨🇳Guiyang, Guizhou, China
The First People's Hospital of Lianyungang
🇨🇳Lianyungang, Jiangsu, China
Suzhou Municipal Hospital
🇨🇳Suzhou, Jiangsu, China
Weifang People's Hospital
🇨🇳Weifang, Shandong, China
Xi'an Central Hospital
🇨🇳Xi'an, Shanxi, China
Wuhan Central Hospital
🇨🇳Wuhan, Hubei, China
Shanghai Fifth People's Hospital,Fudan University
🇨🇳Shanghai, Shanghai, China
Second People's Hospital of Guizhou Province
🇨🇳Guiyang, Guizhou, China
Suzhou Ninth People's Hospital
🇨🇳Suzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
Dongfang Hospital Beijing University of Chinese Medicine
🇨🇳Beijing, Beijing, China
Anhui Mental Health Center
🇨🇳Hefei, Anhui, China
Beijing Luhe Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Red Cross Hospital of Guangzhou
🇨🇳Guangzhou, Guangdong, China
Hebei Petro China Central Hospital
🇨🇳Langfang, Hebei, China
General Hospital of North China Petroleum Administration (North China Hospital Affiliated to University of Chinese Academy of Sciences)
🇨🇳Renqiu, Hebei, China
Changshu No.2 People's Hospital
🇨🇳Suzhou, Jiangsu, China
Nantong No.1 People's Hospital
🇨🇳Nantong, Jiangsu, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
Affiliated Hospital of Jining Medical University
🇨🇳Jining, Shandong, China
Liaocheng People's Hospital
🇨🇳Liaocheng, Shandong, China
Ningbo Kangning Hospital
🇨🇳Ningbo, Zhejiang, China
Ningbo First Hospital
🇨🇳Ningbo, Zhejiang, China
Huamei Hospital,University of Chinese Academy of Sciences
🇨🇳Ningbo, Zhejiang, China
Zhujiang Hospital, Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Shanghai Pudong New Area People's Hospital
🇨🇳Shanghai, Shanghai, China