Safety Study of Adenovirus Hepatocyte Growth Factor to Tr... | NCT01925352

Studies
Safety Study of Adenovirus Hepatocyte Growth Factor to Treat Ischemic Heart Disease

NCT01925352

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Status

Unknown status

Last Update Posted

Aug 20, 2013Estimated

Enrollment

40Estimated

Phase

Phase 1Phase 2

Conditions

Ischemic Heart Disease

Interventions

Ad-HGF

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Aug 15, 2013

First Submission Date that Met QC Criteria

Aug 16, 2013

First Posted Date

Aug 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2013

Last Update Posted Date

Aug 20, 2013Estimated

Name	Class
Academy Military Medical Science, China	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To explore the safety and efficiency of adenovirus-hepatocyte growth factor(Ad-HGF) treatment in ischemic heart disease.

Detailed Description

Ischemic heart disease refers to a group of closely related syndromes by an imbalance between the myocardial oxygen demand and the blood supply.
Gene therapy offers an attractive alternative to current pharmacologic therapies and may be beneficial in refractory disease. Gene therapy with hepatocyte growth factor induces angiogenesis, decreases apoptosis and leads to protection in the ischemic heart. In this study, we mainly explore the safety and effects of adenovirus hepatocyte growth factor for the treatment of ischemic heart disease.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ad-HGF	Experimental	5×10(9)pfu adenovirus hepatocyte growth factor was delivered by transendocardial injection in patients with ischemic heart disease into five left ventricular sites once.	Drug: Ad-HGF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ad-HGF	Drug	5×10(9)pfu adenovirus hepatocyte growth factor was delivered by transendocardial injection into five left ventricular sites.	Ad-HGF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with death,new myocardial infarction or stroke		6 months after treatment

Secondary Outcomes

Measure	Description	Time Frame
left ventricular ejection fraction (LVEF)		6 months after treatment

Other Outcomes

Measure	Description	Time Frame
tumor markers of blood		6 months after treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

person with ischemic heart disease;
Male or female of 20 to 70 years old;
No blood perfusion detected in some area of heart using Single-Photon Emission Computed Tomography(SPECT) or Magnetic Resonance Imaging(MRI)
two or more than two coronary arteries lesions were detected using coronary artery angiography and at least one coronary artery are un-suitable for percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG)；Or patients refuse to perform PCI or CABG
LVEF is ≤45%;
Patients must sign approved informed consent.

Exclusion Criteria:

Acute myocardial infarction occured within one week
CABG performed within 6 months or PCI performed within 3 months
Patients with systemic active infection
Blood alanine aminotransferase (ALT)>135mmol/L or blood crea(Cr)>200umol/L or patients with chronic obstructive pulmonary disease (COPD)
patients with obvious bleeding tendency and blood disease
patients with malignant tumor or end-stage disease
patient anticipated life expectancy is less than 12 months
patient recently attended test drugs or other device research

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dingguo Zhang, PhD.	Contact	86-25-83718836	6640	zhdg0223@aliyun.com

Overall Officials

Name	Affiliation	Role
Zhijian Yang, PhD.	The First Affiliated Hospital with Nanjing Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jiangsu Province Hospital	Recruiting	Nanjing	Jiangsu	210029	China

Condition Browse Module

MeSH Terms

ID	Term
D017202	Myocardial Ischemia
D000257	Adenoviridae Infections
C564265	Deafness, Autosomal Recessive 39

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D004266	DNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided