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

Sponsor

Green Valley (Shanghai) Pharmaceuticals Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05058040

Collaborator

(none)

2,500

Enrollment

Locations

Arm

Anticipated Duration (Months)

38.5

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Drug: Sodium Oligomannate Capsules	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

2500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 2, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Safety Endpoints: Vital signs, laboratory tests , electrocardiogram, and early withdrawal from the study during 48 weeks [48-week]
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 [96-week]
The incidence of adverse events and adverse reactions in patients with liver insufficiency and renal insufficiency receiving GV-971 during 96 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Anhui Mental Health Center	Hefei	Anhui	China
2	The First Affiliated Hospital of USTC(Anhui Provincial Hospital)	Hefei	Anhui	China
3	Beijing Bo'ai Hospital	Beijing	Beijing	China
4	Beijing Geriatric Hospital	Beijing	Beijing	China
5	Beijing Luhe Hospital, Capital Medical University	Beijing	Beijing	China
6	Dongfang Hospital Beijing University of Chinese Medicine	Beijing	Beijing	China
7	Sanbo Brain Hospital Capital Medical University	Beijing	Beijing	China
8	Chongqing 11th People's Hospital (Chongqing Special Care Hospital)	Chongqing	Chongqing	China
9	Xiamen Xianyue Hospital	Xianmen	Fujian	China
10	Dongguan People's Hospital	Dongguan	Guangdong	China
11	Red Cross Hospital of Guangzhou	Guangzhou	Guangdong	China
12	The Third Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong	China
13	Zhujiang Hospital, Southern Medical University	Guangzhou	Guangdong	China
14	Shenzhen Luohu District People's Hospital	Shenzhen	Guangdong	China
15	Shenzhen Second People's Hospital (The First Affiliated Hospital of Shenzhen University)	Shenzhen	Guangdong	China
16	Zhuhai People's Hospital	Zhuhai	Guangdong	China
17	Guihang Guiyang Hospital	Guiyang	Guizhou	China
18	Guizhou Provincial people's Hospital	Guiyang	Guizhou	China
19	Second People's Hospital of Guizhou Province	Guiyang	Guizhou	China
20	The First Affiliated Hospital of Guizhou University of Chinese Medicine	Guiyang	Guizhou	China
21	The Second Affiliated Hospital of Guizhou University of Chinese Medicine	Guiyang	Guizhou	China
22	Baoding Zhuozhou Baoshihua Hospital	Baoding	Hebei	China
23	Hebei Petro China Central Hospital	Langfang	Hebei	China
24	General Hospital of North China Petroleum Administration (North China Hospital Affiliated to University of Chinese Academy of Sciences)	Renqiu	Hebei	China
25	Wuhan Central Hospital	Wuhan	Hubei	China
26	Wuhan Mental Health Center	Wuhan	Hubei	China
27	Lianyungang Chinese Medicine Hospital	Lianyungang	Jiangsu	China
28	The First People's Hospital of Lianyungang	Lianyungang	Jiangsu	China
29	Nanjing First Hospital	Nanjing	Jiangsu	China
30	Nantong No.1 People's Hospital	Nantong	Jiangsu	China
31	Changshu No.2 People's Hospital	Suzhou	Jiangsu	China
32	Suzhou Guangji Hospital	Suzhou	Jiangsu	China
33	Suzhou Municipal Hospital(Geriatrics)	Suzhou	Jiangsu	China
34	Suzhou Municipal Hospital	Suzhou	Jiangsu	China
35	Suzhou Ninth People's Hospital	Suzhou	Jiangsu	China
36	Taizhou Second People's Hospital	Taizhou	Jiangsu	China
37	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu	China
38	Zhenjiang mental health center	Zhenjiang	Jiangsu	China
39	Jinan Central Hospital Affiliated To Shandong University	Jinan	Shandong	China
40	Shandong Mental Health Center	Jinan	Shandong	China
41	Affiliated Hospital of Jining Medical University	Jining	Shandong	China
42	Liaocheng People's Hospital	Liaocheng	Shandong	China
43	Weifang People's Hospital	Weifang	Shandong	China
44	Huashan Hospital affiliated to Fudan University	Shanghai	Shanghai	China
45	Shanghai East Hospital	Shanghai	Shanghai	China
46	Shanghai Fengxian District Central Hospital	Shanghai	Shanghai	China
47	Shanghai Fifth People's Hospital,Fudan University	Shanghai	Shanghai	China
48	Shanghai Pudong New Area People's Hospital	Shanghai	Shanghai	China
49	Tong Ren Hospital,Shanghai Jiao Tong University School Of Medicine	Shanghai	Shanghai	China
50	Second hospital of Shanxi Medical University	Taiyuan	Shanxi	China
51	Shanxi Bethune Hospital	Taiyuan	Shanxi	China
52	Shanxi Provincial People's Hospital	Xi'an	Shanxi	China
53	Xi 'an Baoshihua Changqing Hospital	Xi'an	Shanxi	China
54	Xi'an Central Hospital	Xi'an	Shanxi	China
55	Chengdu Fourth People's Hospital	Chengdu	Sichuang	China
56	The Fifth People's Hospital of Chengdu	Chengdu	Sichuang	China
57	Nanchong Central Hospital	Nanchong	Sichuang	China
58	Chengdu Eighth People's Hospital	Chengdu	Sichuan	China
59	Sichuan Academy of Medical Sciences sichuan Provincial People's Hospital	Chengdu	Sichuan	China
60	Sichuan Baoshihua Hospital	Chengdu	Sichuan	China
61	Huzhou Third Municipal Hospital	Huzhou	Zhejiang	China
62	Huamei Hospital,University of Chinese Academy of Sciences	Ningbo	Zhejiang	China
63	Ningbo First Hospital	Ningbo	Zhejiang	China
64	Ningbo Kangning Hospital	Ningbo	Zhejiang	China
65	Wenzhou People's Hospital	Wenzhou	Zhejiang	China

Sponsors and Collaborators

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05058040

Other Study ID Numbers:

GV-971-PMS-A

First Posted:

Sep 27, 2021

Last Update Posted:

Dec 30, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Dec 30, 2021