A Clinical Study to Evaluate the Long-Term Safety Sodium Oligomannate Capsules (GV-971)

Alzheimer Disease Clinical Trial

Official title:

A Clinical Study to Evaluate the Long-Term Safety Sodium Oligomannate Capsules

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05058040
• Other study ID #: GV-971-PMS-A
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 2, 2021
• Est. completion date: April 2025

Study information

• Verified date: May 2023
• Source: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A clinical study to evaluate the long-term safety of Sodium Oligomannate Capsules (GV-971)

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 2500
• Est. completion date: April 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects eligible for this study must meet all of the following criteria:

1. =18 years of age;

2. Signed informed consent form;

3. Patients receiving GV-971 treatment prescribed by clinicians;

Exclusion Criteria:

• A subject may be excluded from participation in the study if any of the following

apply:

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Beijing Bo'ai Hospital	Beijing	Beijing
China	Beijing Geriatric Hospital	Beijing	Beijing
China	Beijing Luhe Hospital, Capital Medical University	Beijing	Beijing
China	Dongfang Hospital Beijing University of Chinese Medicine	Beijing	Beijing
China	Sanbo Brain Hospital Capital Medical University	Beijing	Beijing
China	Chengdu Eighth People's Hospital	Chengdu	Sichuan
China	Chengdu Fourth People's Hospital	Chengdu	Sichuang
China	Sichuan Academy of Medical Sciences sichuan Provincial People's Hospital	Chengdu	Sichuan
China	Sichuan Baoshihua Hospital	Chengdu	Sichuan
China	The Fifth People's Hospital of Chengdu	Chengdu	Sichuang
China	Chongqing 11th People's Hospital (Chongqing Special Care Hospital)	Chongqing	Chongqing
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	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	Anhui Mental Health Center	Hefei	Anhui
China	The First Affiliated Hospital of USTC(Anhui Provincial Hospital)	Hefei	Anhui
China	Huzhou Third Municipal Hospital	Huzhou	Zhejiang
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	Hebei Petro China Central Hospital	Langfang	Hebei
China	Lianyungang Chinese Medicine Hospital	Lianyungang	Jiangsu
China	The First People's Hospital of Lianyungang	Lianyungang	Jiangsu
China	Liaocheng People's Hospital	Liaocheng	Shandong
China	Nanchong Central Hospital	Nanchong	Sichuang
China	Nanjing First Hospital	Nanjing	Jiangsu
China	Nantong No.1 People's Hospital	Nantong	Jiangsu
China	Huamei Hospital,University of Chinese Academy of Sciences	Ningbo	Zhejiang
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Ningbo Kangning Hospital	Ningbo	Zhejiang
China	General Hospital of North China Petroleum Administration (North China Hospital Affiliated to University of Chinese Academy of Sciences)	Renqiu	Hebei
China	Huashan Hospital affiliated to Fudan University	Shanghai	Shanghai
China	Shanghai East Hospital	Shanghai	Shanghai
China	Shanghai Fengxian District Central Hospital	Shanghai	Shanghai
China	Shanghai Fifth People's Hospital,Fudan University	Shanghai	Shanghai
China	Shanghai Pudong New Area People's Hospital	Shanghai	Shanghai
China	Tong Ren Hospital,Shanghai Jiao Tong University School Of Medicine	Shanghai	Shanghai
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	Changshu No.2 People's Hospital	Suzhou	Jiangsu
China	Suzhou Guangji Hospital	Suzhou	Jiangsu
China	Suzhou Municipal Hospital	Suzhou	Jiangsu
China	Suzhou Municipal Hospital(Geriatrics)	Suzhou	Jiangsu
China	Suzhou Ninth People's Hospital	Suzhou	Jiangsu
China	Second hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Shanxi Bethune Hospital	Taiyuan	Shanxi
China	Taizhou Second People's Hospital	Taizhou	Jiangsu
China	Weifang People's Hospital	Weifang	Shandong
China	Wenzhou People's Hospital	Wenzhou	Zhejiang
China	Wuhan Central Hospital	Wuhan	Hubei
China	Wuhan Mental Health Center	Wuhan	Hubei
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	Xiamen Xianyue Hospital	Xianmen	Fujian
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
China	Zhenjiang mental health center	Zhenjiang	Jiangsu
China	Zhuhai People's Hospital	Zhuhai	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Safety Endpoints: Vital signs, laboratory tests , electrocardiogram, and early withdrawal from the study during 48 weeks	The incidence of adverse events and adverse reactions in patients with liver insufficiency and renal insufficiency receiving GV-971 during 48 weeks	48-week
Secondary	Safety Endpoints: Vital signs, laboratory tests , electrocardiogram, and early withdrawal from the study during 96 weeks	The incidence of adverse events and adverse reactions in patients with liver insufficiency and renal insufficiency receiving GV-971 during 96 weeks	96-week