Trials Sponsors Conditions Drugs Pricing

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (2)

Adverse events (AEs) and serious adverse events (SAEs)
Incidence of AE and SAE, as assessed by physical examinations, clinical laboratory parameters and adverse event reporting
52 weeks
Changes in annualized bleeding rate (ABR)
Changes in annualized bleeding rate (ABR) from baseline to 52 weeks.
52 weeks

Secondary Outcomes (4)

FVIII activity levels
52 weeks
FVIII protein product infusions
52 weeks
Target joints
52 weeks
HA-QOL scores
52 weeks

Study Arms (1)

Experimental

EXPERIMENTAL

3 doses of NGGT003 will be administered according to the principle of dose escalation

Drug: NGGT003

Interventions

NGGT003Drug

Single intravenous infusion of NGGT003 at low dose (4e11vg/kg), medium dose (1e12vg/kg) and high dose (2.5e12vg/kg)

Experimental

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Voluntarily sign the informed consent form;
Male, age ≥18 years old;

Sponsors & Collaborators

Institute of Hematology & Blood Diseases Hospital, China
Otherlead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

Lei Zhang, MDCONTACT+862223909240 zhanglei1@ihcams.ac.cn

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

Lei Zhang, MD
Institute of Hematology & Blood Diseases Hospital, China
PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Liu, MD

CONTACT

+862223909240 liuwei1@ihcams.ac.cn

Lei Zhang, MD

CONTACT

+862223909240

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 26, 2024

First Posted

February 2, 2024

Study Start

January 17, 2024

Actual (reported)

Primary Completion

January 31, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Safety and Efficacy Study of NGGT003 in Hemophilia A Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

Experimental

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

Experimental

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations