Clinical trial NCT05058040: A Clinical Study to Evaluate the Long-Term Safety Sodium Oligomannate Capsules (GV-971)
Official title: A Clinical Study to Evaluate the Long-Term Safety Sodium Oligomannate Capsules
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Alzheimer Disease
Lead sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-27
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Long-term safety of GV-971 in clinical practice during 48 weeks
timeFrame: Week 48
measure: Long-term safety of GV-971 in clinical practice during 96 weeks
timeFrame: Week 96
Secondary outcomes:
measure: Safety Endpoints: Vital signs, laboratory tests , electrocardiogram, and early withdrawal from the study during 48 weeks
timeFrame: 48-week
measure: Safety Endpoints: Vital signs, laboratory tests , electrocardiogram, and early withdrawal from the study during 96 weeks
timeFrame: 96-week
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Mental Health Center
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC(Anhui Provincial Hospital)
state: Anhui
city: Beijing
country: China
facility: Beijing Bo'ai Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Geriatric Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Dongfang Hospital Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Sanbo Brain Hospital Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Chongqing 11th People's Hospital (Chongqing Special Care Hospital)
state: Chongqing
city: Xianmen
country: China
facility: Xiamen Xianyue Hospital
state: Fujian
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Red Cross Hospital of Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital, Southern Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Luohu District People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital (The First Affiliated Hospital of Shenzhen University)
state: Guangdong
city: Zhuhai
country: China
facility: Zhuhai People's Hospital
state: Guangdong
city: Guiyang
country: China
facility: Guihang Guiyang Hospital
state: Guizhou
city: Guiyang
country: China
facility: Second People's Hospital of Guizhou Province
state: Guizhou
city: Guiyang
country: China
facility: The First Affiliated Hospital of Guizhou University of Chinese Medicine
state: Guizhou
city: Guiyang
country: China
facility: The Second Affiliated Hospital of Guizhou University of Chinese Medicine
state: Guizhou
city: Langfang
country: China
facility: Hebei Petro China Central Hospital
state: Hebei
city: Renqiu
country: China
facility: General Hospital of North China Petroleum Administration (North China Hospital Affiliated to University of Chinese Academy of Sciences)
state: Hebei
city: Wuhan
country: China
facility: Wuhan Central Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Mental Health Center
state: Hubei
city: Lianyungang
country: China
facility: Lianyungang Chinese Medicine Hospital
state: Jiangsu
city: Lianyungang
country: China
facility: The First People's Hospital of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nantong
country: China
facility: Nantong No.1 People's Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Changshu No.2 People's Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Guangji Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Municipal Hospital(Geriatrics)
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Ninth People's Hospital
state: Jiangsu
city: Taizhou
country: China
facility: Taizhou Second People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Zhenjiang
country: China
facility: Zhenjiang mental health center
state: Jiangsu
city: Jinan
country: China
facility: Jinan Central Hospital Affiliated To Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Mental Health Center
state: Shandong
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
state: Shandong
city: Weifang
country: China
facility: Weifang People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Fengxian District Central Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Fifth People's Hospital,Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong New Area People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Tong Ren Hospital,Shanghai Jiao Tong University School Of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: Second hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Xi'an
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Xi'an
country: China
facility: Xi 'an Baoshihua Changqing Hospital
state: Shanxi
city: Xi'an
country: China
facility: Xi'an Central Hospital
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Fourth People's Hospital
state: Sichuang
city: Chengdu
country: China
facility: The Fifth People's Hospital of Chengdu
state: Sichuang
city: Nanchong
country: China
facility: Nanchong Central Hospital
state: Sichuang
city: Chengdu
country: China
facility: Chengdu Eighth People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences sichuan Provincial People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Baoshihua Hospital
state: Sichuan
city: Huzhou
country: China
facility: Huzhou Third Municipal Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Huamei Hospital,University of Chinese Academy of Sciences
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Kangning Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou People's Hospital
state: Zhejiang
Study officials:
References: