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Study to Assess the Safety and Efficacy of Multiple Doses of VB-201 on Biomarkers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier:
NCT01159730
First received: July 8, 2010
Last updated: November 15, 2011
Last verified: November 2011
July 8, 2010
November 15, 2011
October 2010
October 2011   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01159730 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Assess the Safety and Efficacy of Multiple Doses of VB-201 on Biomarkers
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Effect of Multiple Doses of VB-201 on Biomarkers
The purpose of this study is to assess the safety and tolerability of multiple doses of VB-201 administered for 4 weeks and its efficacy on biomarkers.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Biomarker
Drug: VB-201 or Placebo
  • Experimental: Multiple doses of VB-201
    Intervention: Drug: VB-201 or Placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: VB-201 or Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
320
October 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female patients, ≥18 to ≤75 years of age;

Exclusion Criteria:

  • Presence of, or history of cancer, with the exception of completely excised, non-metastatic squamous cell or basal cell carcinomas of the skin;
  • Has a clinically significant systemic infection (e.g., chronic or acute infection, UTI, URI) within 30 days of Day 0, or a history or presence of recurrent or chronic infection (e.g. viral infections, [including hepatitis B or C, HIV], bacterial infections, systemic fungal infections, or syphilis);
  • Subjects with a history of coronary events within the last 6 months;
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01159730
VB-201-030
Yes
Not Provided
Not Provided
Vascular Biogenics Ltd. operating as VBL Therapeutics
Vascular Biogenics Ltd. operating as VBL Therapeutics
Not Provided
Not Provided
Vascular Biogenics Ltd. operating as VBL Therapeutics
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP