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

NCT01925352 | Unknown Phase 1 DMC

• 1 other identifier: HIHD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemic Heart Disease

Keywords

ischemic heart disease; adenovirus; hepatocyte growth factor

Outcome Measures

Primary Outcomes (1)

• Number of participants with death,new myocardial infarction or stroke

  6 months after treatment

Secondary Outcomes (1)

• left ventricular ejection fraction (LVEF)

  6 months after treatment

Other Outcomes (1)

• tumor markers of blood

  6 months after treatment

Study Arms (1)

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

Ad-HGF DRUG

5×10(9)pfu adenovirus hepatocyte growth factor was delivered by transendocardial injection into five left ventricular sites.

Also known as: adenovirs hepatocyte growth factor

Ad-HGF

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Academy Military Medical Science, China: collaborator

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia; Adenoviridae Infections; Deafness, Autosomal Recessive 39

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Zhijian Yang, PhD.

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dingguo Zhang, PhD.

CONTACT

86-25-83718836; zhdg0223@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 19, 2013
• Study Start: November 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 20, 2013

Record last verified: 2013-08

Locations

CN (1)