A Clinical Study to Evaluate the Long-Term Safety Sodium Oligomannate Capsules (GV-971)
NCT ID: NCT05058040
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
2500 participants
INTERVENTIONAL
2021-06-02
2025-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GV-971
The recommended dose regimen for subjects: GV-971 450 mg (3 capsules) per dose, bid, po. in morning and evening
Sodium Oligomannate Capsules
Sodium Oligomannate Capsules, each capsule contains 150 mg of sodium oligomannate. The recommended treatment is oral administration, 450 mg (3 capsules) per dose, bid, in morning and evening.
Interventions
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Sodium Oligomannate Capsules
Sodium Oligomannate Capsules, each capsule contains 150 mg of sodium oligomannate. The recommended treatment is oral administration, 450 mg (3 capsules) per dose, bid, in morning and evening.
Eligibility Criteria
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Inclusion Criteria
1. ≥18 years of age;
2. Signed informed consent form;
3. Patients receiving GV-971 treatment prescribed by clinicians;
Exclusion Criteria
1. Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator;
2. Female participants who are pregnant or lactating;
3. Patients who cannot cooperate to complete the follow-up inquiries;
4. Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.
18 Years
ALL
No
Sponsors
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Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Anhui Mental Health Center
Hefei, Anhui, China
The First Affiliated Hospital of USTC(Anhui Provincial Hospital)
Hefei, Anhui, China
Beijing Bo'ai Hospital
Beijing, Beijing Municipality, China
Beijing Geriatric Hospital
Beijing, Beijing Municipality, China
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Dongfang Hospital Beijing University of Chinese Medicine
Beijing, Beijing Municipality, China
Sanbo Brain Hospital Capital Medical University
Beijing, Beijing Municipality, China
Chongqing 11th People's Hospital (Chongqing Special Care Hospital)
Chongqing, Chongqing Municipality, China
Xiamen Xianyue Hospital
Xianmencun, Fujian, China
Dongguan People's Hospital
Dongguan, Guangdong, China
Red Cross Hospital of Guangzhou
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Shenzhen Luohu District People's Hospital
Shenzhen, Guangdong, China
Shenzhen Second People's Hospital (The First Affiliated Hospital of Shenzhen University)
Shenzhen, Guangdong, China
Zhuhai People's Hospital
Zhuhai, Guangdong, China
Guihang Guiyang Hospital
Guiyang, Guizhou, China
Second People's Hospital of Guizhou Province
Guiyang, Guizhou, China
The First Affiliated Hospital of Guizhou University of Chinese Medicine
Guiyang, Guizhou, China
The Second Affiliated Hospital of Guizhou University of Chinese Medicine
Guiyang, Guizhou, 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
Wuhan Central Hospital
Wuhan, Hubei, China
Wuhan Mental Health Center
Wuhan, Hubei, China
Lianyungang Chinese Medicine Hospital
Lianyungang, Jiangsu, China
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Nantong No.1 People's Hospital
Nantong, Jiangsu, China
Changshu No.2 People's Hospital
Suzhou, Jiangsu, China
Suzhou Guangji Hospital
Suzhou, Jiangsu, China
Suzhou Municipal Hospital(Geriatrics)
Suzhou, Jiangsu, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Suzhou Ninth People's Hospital
Suzhou, Jiangsu, China
Taizhou Second People's Hospital
Taizhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Zhenjiang mental health center
Zhenjiang, Jiangsu, China
Jinan Central Hospital Affiliated To Shandong University
Jinan, Shandong, China
Shandong Mental Health Center
Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Weifang People's Hospital
Weifang, Shandong, China
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Shanghai Fengxian District Central Hospital
Shanghai, Shanghai Municipality, China
Shanghai Fifth People's Hospital,Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Pudong New Area People's Hospital
Shanghai, Shanghai Municipality, China
Tong Ren Hospital,Shanghai Jiao Tong University School Of Medicine
Shanghai, Shanghai Municipality, China
Second hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Shanxi Provincial People's Hospital
Xi’an, Shanxi, China
Xi 'an Baoshihua Changqing Hospital
Xi’an, Shanxi, China
Xi'an Central Hospital
Xi’an, Shanxi, China
Chengdu Eighth People's Hospital
Chengdu, Sichuan, China
Sichuan Academy of Medical Sciences sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Sichuan Baoshihua Hospital
Chengdu, Sichuan, China
Chengdu Fourth People's Hospital
Chengdu, Sichuang, China
The Fifth People's Hospital of Chengdu
Chengdu, Sichuang, China
Nanchong Central Hospital
Nanchong, Sichuang, China
Huzhou Third Municipal Hospital
Huzhou, Zhejiang, China
Huamei Hospital,University of Chinese Academy of Sciences
Ningbo, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
Ningbo Kangning Hospital
Ningbo, Zhejiang, China
Wenzhou People's Hospital
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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GV-971-PMS-A
Identifier Type: -
Identifier Source: org_study_id
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