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

Primary Purpose

Alzheimer Disease

Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sodium Oligomannate Capsules
Sponsored by
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Anhui Mental Health Center
  • The First Affiliated Hospital of USTC(Anhui Provincial Hospital)
  • Beijing Bo'ai Hospital
  • Beijing Geriatric Hospital
  • Beijing Luhe Hospital, Capital Medical University
  • Dongfang Hospital Beijing University of Chinese Medicine
  • Sanbo Brain Hospital Capital Medical University
  • Chongqing 11th People's Hospital (Chongqing Special Care Hospital)
  • Xiamen Xianyue Hospital
  • Dongguan People's Hospital
  • Red Cross Hospital of Guangzhou
  • The Third Affiliated Hospital of Guangzhou Medical University
  • Zhujiang Hospital, Southern Medical University
  • Shenzhen Luohu District People's Hospital
  • Shenzhen Second People's Hospital (The First Affiliated Hospital of Shenzhen University)
  • Zhuhai People's Hospital
  • Guihang Guiyang Hospital
  • Second People's Hospital of Guizhou Province
  • The First Affiliated Hospital of Guizhou University of Chinese Medicine
  • The Second Affiliated Hospital of Guizhou University of Chinese Medicine
  • Hebei Petro China Central Hospital
  • General Hospital of North China Petroleum Administration (North China Hospital Affiliated to University of Chinese Academy of Sciences)
  • Wuhan Central Hospital
  • Wuhan Mental Health Center
  • Lianyungang Chinese Medicine Hospital
  • The First People's Hospital of Lianyungang
  • Nanjing First Hospital
  • Nantong No.1 People's Hospital
  • Changshu No.2 People's Hospital
  • Suzhou Guangji Hospital
  • Suzhou Municipal Hospital(Geriatrics)
  • Suzhou Municipal Hospital
  • Suzhou Ninth People's Hospital
  • Taizhou Second People's Hospital
  • Affiliated Hospital of Jiangsu University
  • Zhenjiang mental health center
  • Jinan Central Hospital Affiliated To Shandong University
  • Shandong Mental Health Center
  • Affiliated Hospital of Jining Medical University
  • Liaocheng People's Hospital
  • Weifang People's Hospital
  • Huashan Hospital affiliated to Fudan University
  • Shanghai East Hospital
  • Shanghai Fengxian District Central Hospital
  • Shanghai Fifth People's Hospital,Fudan University
  • Shanghai Pudong New Area People's Hospital
  • Tong Ren Hospital,Shanghai Jiao Tong University School Of Medicine
  • Second hospital of Shanxi Medical University
  • Shanxi Bethune Hospital
  • Shanxi Provincial People's Hospital
  • Xi 'an Baoshihua Changqing Hospital
  • Xi'an Central Hospital
  • Chengdu Fourth People's Hospital
  • The Fifth People's Hospital of Chengdu
  • Nanchong Central Hospital
  • Chengdu Eighth People's Hospital
  • Sichuan Academy of Medical Sciences sichuan Provincial People's Hospital
  • Sichuan Baoshihua Hospital
  • Huzhou Third Municipal Hospital
  • Huamei Hospital,University of Chinese Academy of Sciences
  • Ningbo First Hospital
  • Ningbo Kangning Hospital
  • Wenzhou People's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GV-971

Arm Description

The recommended dose regimen for subjects: GV-971 450 mg (3 capsules) per dose, bid, po. in morning and evening

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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

Full Information

First Posted
May 16, 2021
Last Updated
May 25, 2023
Sponsor
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05058040
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GV-971
Arm Type
Experimental
Arm Description
The recommended dose regimen for subjects: GV-971 450 mg (3 capsules) per dose, bid, po. in morning and evening
Intervention Type
Drug
Intervention Name(s)
Sodium Oligomannate Capsules
Intervention Description
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.
Primary Outcome Measure Information:
Title
Long-term safety of GV-971 in clinical practice during 48 weeks
Description
The incidence of adverse reactions and AE/SAE in patients treated with GV-971 during the 48-week monitoring period
Time Frame
Week 48
Title
Long-term safety of GV-971 in clinical practice during 96 weeks
Description
The incidence of adverse reactions and AE/SAE in patients treated with GV-971 during the 96-week monitoring period
Time Frame
Week 96
Secondary Outcome Measure Information:
Title
Safety Endpoints: Vital signs, laboratory tests , electrocardiogram, and early withdrawal from the study during 48 weeks
Description
The incidence of adverse events and adverse reactions in patients with liver insufficiency and renal insufficiency receiving GV-971 during 48 weeks
Time Frame
48-week
Title
Safety Endpoints: Vital signs, laboratory tests , electrocardiogram, and early withdrawal from the study during 96 weeks
Description
The incidence of adverse events and adverse reactions in patients with liver insufficiency and renal insufficiency receiving GV-971 during 96 weeks
Time Frame
96-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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.
Facility Information:
Facility Name
Anhui Mental Health Center
City
Hefei
State/Province
Anhui
Country
China
Facility Name
The First Affiliated Hospital of USTC(Anhui Provincial Hospital)
City
Hefei
State/Province
Anhui
Country
China
Facility Name
Beijing Bo'ai Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Geriatric Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Luhe Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Dongfang Hospital Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Sanbo Brain Hospital Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chongqing 11th People's Hospital (Chongqing Special Care Hospital)
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
Xiamen Xianyue Hospital
City
Xianmen
State/Province
Fujian
Country
China
Facility Name
Dongguan People's Hospital
City
Dongguan
State/Province
Guangdong
Country
China
Facility Name
Red Cross Hospital of Guangzhou
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The Third Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Zhujiang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Shenzhen Luohu District People's Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
Shenzhen Second People's Hospital (The First Affiliated Hospital of Shenzhen University)
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
Zhuhai People's Hospital
City
Zhuhai
State/Province
Guangdong
Country
China
Facility Name
Guihang Guiyang Hospital
City
Guiyang
State/Province
Guizhou
Country
China
Facility Name
Second People's Hospital of Guizhou Province
City
Guiyang
State/Province
Guizhou
Country
China
Facility Name
The First Affiliated Hospital of Guizhou University of Chinese Medicine
City
Guiyang
State/Province
Guizhou
Country
China
Facility Name
The Second Affiliated Hospital of Guizhou University of Chinese Medicine
City
Guiyang
State/Province
Guizhou
Country
China
Facility Name
Hebei Petro China Central Hospital
City
Langfang
State/Province
Hebei
Country
China
Facility Name
General Hospital of North China Petroleum Administration (North China Hospital Affiliated to University of Chinese Academy of Sciences)
City
Renqiu
State/Province
Hebei
Country
China
Facility Name
Wuhan Central Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Wuhan Mental Health Center
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Lianyungang Chinese Medicine Hospital
City
Lianyungang
State/Province
Jiangsu
Country
China
Facility Name
The First People's Hospital of Lianyungang
City
Lianyungang
State/Province
Jiangsu
Country
China
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Nantong No.1 People's Hospital
City
Nantong
State/Province
Jiangsu
Country
China
Facility Name
Changshu No.2 People's Hospital
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Suzhou Guangji Hospital
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Suzhou Municipal Hospital(Geriatrics)
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Suzhou Municipal Hospital
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Suzhou Ninth People's Hospital
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
Taizhou Second People's Hospital
City
Taizhou
State/Province
Jiangsu
Country
China
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
Country
China
Facility Name
Zhenjiang mental health center
City
Zhenjiang
State/Province
Jiangsu
Country
China
Facility Name
Jinan Central Hospital Affiliated To Shandong University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Shandong Mental Health Center
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Affiliated Hospital of Jining Medical University
City
Jining
State/Province
Shandong
Country
China
Facility Name
Liaocheng People's Hospital
City
Liaocheng
State/Province
Shandong
Country
China
Facility Name
Weifang People's Hospital
City
Weifang
State/Province
Shandong
Country
China
Facility Name
Huashan Hospital affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Fengxian District Central Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Fifth People's Hospital,Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Pudong New Area People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tong Ren Hospital,Shanghai Jiao Tong University School Of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Second hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Shanxi Bethune Hospital
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Shanxi Provincial People's Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
Xi 'an Baoshihua Changqing Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
Xi'an Central Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
Chengdu Fourth People's Hospital
City
Chengdu
State/Province
Sichuang
Country
China
Facility Name
The Fifth People's Hospital of Chengdu
City
Chengdu
State/Province
Sichuang
Country
China
Facility Name
Nanchong Central Hospital
City
Nanchong
State/Province
Sichuang
Country
China
Facility Name
Chengdu Eighth People's Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Sichuan Academy of Medical Sciences sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Sichuan Baoshihua Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Huzhou Third Municipal Hospital
City
Huzhou
State/Province
Zhejiang
Country
China
Facility Name
Huamei Hospital,University of Chinese Academy of Sciences
City
Ningbo
State/Province
Zhejiang
Country
China
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Facility Name
Ningbo Kangning Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Facility Name
Wenzhou People's Hospital
City
Wenzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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