A Clinical Study to Evaluate the Long-Term Safety Sodium Oligomannate Capsules (GV-971)
1 other identifier
interventional
2,500
1 country
63
Brief Summary
A clinical study to evaluate the long-term safety of Sodium Oligomannate Capsules (GV-971)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 alzheimer-disease
Started Jun 2021
Typical duration for phase_4 alzheimer-disease
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2021
CompletedStudy Start
First participant enrolled
June 2, 2021
CompletedFirst Posted
Study publicly available on registry
September 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedJanuary 24, 2025
November 1, 2024
3.6 years
May 16, 2021
January 22, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Long-term safety of GV-971 in clinical practice during 48 weeks
The incidence of adverse reactions and AE/SAE in patients treated with GV-971 during the 48-week monitoring period
Week 48
Long-term safety of GV-971 in clinical practice during 96 weeks
The incidence of adverse reactions and AE/SAE in patients treated with GV-971 during the 96-week monitoring period
Week 96
Secondary Outcomes (2)
Safety Endpoints: Vital signs, laboratory tests , electrocardiogram, and early withdrawal from the study during 48 weeks
48-week
Safety Endpoints: Vital signs, laboratory tests , electrocardiogram, and early withdrawal from the study during 96 weeks
96-week
Study Arms (1)
GV-971
EXPERIMENTALThe recommended dose regimen for subjects: GV-971 450 mg (3 capsules) per dose, bid, po. in morning and evening
Interventions
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
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2021
First Posted
September 27, 2021
Study Start
June 2, 2021
Primary Completion
January 1, 2025
Study Completion
April 1, 2025
Last Updated
January 24, 2025
Record last verified: 2024-11