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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: Sodium Oligomannate Capsules

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.

• Study Type: Interventional
• Enrollment (Actual): 2500
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Anhui Mental Health Center
    • Hefei, Anhui, China
      • The First Affiliated Hospital of USTC(Anhui Provincial Hospital)
  • Beijing
    • Beijing, Beijing, 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
  • Chongqing
    • Chongqing, Chongqing, China
      • Chongqing 11th People's Hospital (Chongqing Special Care Hospital)
  • Fujian
    • Xianmen, Fujian, China
      • Xiamen Xianyue Hospital
  • Guangdong
    • Dongguan, Guangdong, China
      • Dongguan People's Hospital
    • Guangzhou, Guangdong, China
      • The Third Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China
      • Zhujiang Hospital, Southern Medical University
    • Guangzhou, Guangdong, China
      • Red Cross Hospital of Guangzhou
    • Shenzhen, Guangdong, China
      • Shenzhen Luohu District People's Hospital
    • Shenzhen, Guangdong, China
      • Shenzhen Second People's Hospital (the First Affiliated Hospital of Shenzhen University)
    • Zhuhai, Guangdong, China
      • Zhuhai People's Hospital
  • Guizhou
    • Guiyang, Guizhou, China
      • The Second Affiliated Hospital of Guizhou University of Chinese Medicine
    • Guiyang, Guizhou, 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
  • Hebei
    • Langfang, Hebei, China
      • Hebei Petro China Central Hospital
    • Renqiu, Hebei, China
      • General Hospital of North China Petroleum Administration (North China Hospital Affiliated to University of Chinese Academy of Sciences)
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan Central Hospital
    • Wuhan, Hubei, China
      • Wuhan Mental Health Center
  • Jiangsu
    • Lianyungang, Jiangsu, China
      • The First People's Hospital of Lianyungang
    • Lianyungang, Jiangsu, China
      • Lianyungang Chinese Medicine Hospital
    • Nanjing, Jiangsu, China
      • Nanjing First Hospital
    • Nantong, Jiangsu, China
      • Nantong No.1 People's Hospital
    • Suzhou, Jiangsu, China
      • Suzhou Municipal Hospital
    • Suzhou, 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 Ninth People's Hospital
    • Taizhou, Jiangsu, China
      • Taizhou Second People's Hospital
    • Zhenjiang, Jiangsu, China
      • Affiliated Hospital of Jiangsu University
    • Zhenjiang, Jiangsu, China
      • Zhenjiang Mental Health Center
  • Shandong
    • Jinan, Shandong, China
      • Shandong Mental Health Center
    • Jinan, Shandong, China
      • Jinan Central Hospital Affiliated to Shandong University
    • Jining, Shandong, China
      • Affiliated Hospital of Jining Medical University
    • Liaocheng, Shandong, China
      • Liaocheng People's Hospital
    • Weifang, Shandong, China
      • Weifang People's Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai East Hospital
    • Shanghai, Shanghai, China
      • Huashan Hospital Affiliated to Fudan University
    • Shanghai, Shanghai, China
      • Shanghai Pudong New Area People's Hospital
    • Shanghai, Shanghai, China
      • Shanghai Fengxian District Central Hospital
    • Shanghai, Shanghai, China
      • Shanghai Fifth People's Hospital,Fudan University
    • Shanghai, Shanghai, China
      • Tong Ren Hospital,Shanghai Jiao Tong University School Of Medicine
  • Shanxi
    • Taiyuan, Shanxi, China
      • Shanxi Bethune Hospital
    • Taiyuan, Shanxi, China
      • Second Hospital of Shanxi Medical University
    • Xi'an, Shanxi, China
      • Xi'an Central Hospital
    • Xi'an, Shanxi, China
      • Shanxi Provincial People's Hospital
    • Xi'an, Shanxi, China
      • Xi 'an Baoshihua Changqing Hospital
  • Sichuan
    • Chengdu, Sichuan, 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
  • Sichuang
    • Chengdu, Sichuang, China
      • Chengdu Fourth People's Hospital
    • Chengdu, Sichuang, China
      • The Fifth People's Hospital of Chengdu
    • Nanchong, Sichuang, China
      • Nanchong Central Hospital
  • Zhejiang
    • Huzhou, Zhejiang, China
      • Huzhou Third Municipal Hospital
    • Ningbo, Zhejiang, China
      • Ningbo First Hospital
    • Ningbo, Zhejiang, China
      • Ningbo Kangning Hospital
    • Ningbo, Zhejiang, China
      • Huamei Hospital,University of Chinese Academy of Sciences
    • Wenzhou, Zhejiang, China
      • Wenzhou People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GV-971; The recommended dose regimen for subjects: GV-971 450 mg (3 capsules) per dose, bid, po. in morning and evening	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: May 16, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: GV-971-PMS-A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No