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

NCT05058040 · tracked via the Priya Life Science China tracker

Sponsor

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Phase

Phase 4

Started

2021-06-02

Last updated

2025-01-24

Condition(s) studied

Alzheimer Disease

Investigational drug(s) / intervention(s)

Sodium Oligomannate Capsules

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.

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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.

Primary outcome measure(s)

Long-term safety of GV-971 in clinical practice during 48 weeks — Week 48
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 — Week 96
The incidence of adverse reactions and AE/SAE in patients treated with GV-971 during the 96-week monitoring period

Trial sites (63)

Facility	City	Region
Anhui Mental Health Center	Hefei	Anhui
The First Affiliated Hospital of USTC(Anhui Provincial Hospital)	Hefei	Anhui
Beijing Bo'ai Hospital	Beijing	Beijing Municipality
Beijing Geriatric Hospital	Beijing	Beijing Municipality
Beijing Luhe Hospital, Capital Medical University	Beijing	Beijing Municipality
Dongfang Hospital Beijing University of Chinese Medicine	Beijing	Beijing Municipality
Sanbo Brain Hospital Capital Medical University	Beijing	Beijing Municipality
Chongqing 11th People's Hospital (Chongqing Special Care Hospital)	Chongqing	Chongqing Municipality
Xiamen Xianyue Hospital	Xianmencun	Fujian
Dongguan People's Hospital	Dongguan	Guangdong
Red Cross Hospital of Guangzhou	Guangzhou	Guangdong
The Third Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
Zhujiang Hospital, Southern Medical University	Guangzhou	Guangdong
Shenzhen Luohu District People's Hospital	Shenzhen	Guangdong
Shenzhen Second People's Hospital (The First Affiliated Hospital of Shenzhen University)	Shenzhen	Guangdong
Zhuhai People's Hospital	Zhuhai	Guangdong
Guihang Guiyang Hospital	Guiyang	Guizhou
Second People's Hospital of Guizhou Province	Guiyang	Guizhou
The First Affiliated Hospital of Guizhou University of Chinese Medicine	Guiyang	Guizhou
The Second Affiliated Hospital of Guizhou University of Chinese Medicine	Guiyang	Guizhou
Hebei Petro China Central Hospital	Langfang	Hebei
General Hospital of North China Petroleum Administration (North China Hospital Affiliated to University of Chinese Academy of Sciences)	Renqiu	Hebei
Wuhan Central Hospital	Wuhan	Hubei
Wuhan Mental Health Center	Wuhan	Hubei
Lianyungang Chinese Medicine Hospital	Lianyungang	Jiangsu
The First People's Hospital of Lianyungang	Lianyungang	Jiangsu
Nanjing First Hospital	Nanjing	Jiangsu
Nantong No.1 People's Hospital	Nantong	Jiangsu
Changshu No.2 People's Hospital	Suzhou	Jiangsu
Suzhou Guangji Hospital	Suzhou	Jiangsu
Suzhou Municipal Hospital(Geriatrics)	Suzhou	Jiangsu
Suzhou Municipal Hospital	Suzhou	Jiangsu
Suzhou Ninth People's Hospital	Suzhou	Jiangsu
Taizhou Second People's Hospital	Taizhou	Jiangsu
Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
Zhenjiang mental health center	Zhenjiang	Jiangsu
Jinan Central Hospital Affiliated To Shandong University	Jinan	Shandong
Shandong Mental Health Center	Jinan	Shandong
Affiliated Hospital of Jining Medical University	Jining	Shandong
Liaocheng People's Hospital	Liaocheng	Shandong

+ 23 more sites — see the full list on the official registry below.

More Green Valley (Shanghai) Pharmaceuticals Co., Ltd. trials in China

An Efficacy and Safety Study of Sodium Oligomannate (GV-971) for the Treatment of Alzheimer's Disease Recruiting

Long-term Efficacy and Safety Study of GV-971 Active, not recruiting

Other trials for the same condition

China Longitudinal Aging and Cognitive Impairment Study Recruiting

Phase 3, Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AR1001 in Participants With Early Alzheimer's Disease (Polaris-AD) Active, not recruiting

Study on Biomarkers for Early Diagnosis of Alzheimer's Disease Recruiting

The Peripheral Blood Multi-Omics Study on Sleep Loss Recruiting

Transcranial Alternating Current Stimulation for Patients With Mild Alzheimer's Disease II (TRANSFORM-AD II) Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05058040 on ClinicalTrials.gov ↗ ← All trials in China