NCT02356809

Brief Summary

The purpose of this study is to determine whether pl-vegf165 (Neovasculgen) is effective in the treatment of digital ulcers related to secondary Raynaud's phenomenon associated with systemic scleroderma

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 5, 2015

Status Verified

January 1, 2015

Enrollment Period

Same day

First QC Date

January 26, 2015

Last Update Submit

February 2, 2015

Conditions

Secondary Raynaud's Phenomenon

Keywords

Gene therapy, plasmid, vegf, systemic scleroderma,secondary raynaud's phenomenon

Outcome Measures

Primary Outcomes (2)

  • Frequency of new digital ulcers

    To determine the ability of pl-vegf165 to prevent development of new digital ulcers the frequency of new digital ulcers will be measured in both groups and then compared

    180 days

  • Frequency of adverse events

    180 days

Secondary Outcomes (2)

  • Time of complete healing of digital ulcers

    180 days

  • Pain scores on the visual analog scale

    180 days

Study Arms (2)

pl-vegf165

EXPERIMENTAL

Patients of this group will receive 2,4 mg of pl-vegf165 administered by intramuscular injection which is given in the hand

Drug: Neovasculgen

standard care

NO INTERVENTION

Patients of this group will receive standard therapy accepted in a clinical centre

Interventions

NeovasculgenDRUG

Neovasculgen is an original gene construction that contains supercoiled plasmid DNA (1.2 mg) that encodes pCMV-vegf165 as the active substance. The drug will be supplied to the study centre as a sterile lyophilisate that will be then dissolved in 2 ml of water for injections immediately prior to administration. The drug will be administered intramuscularly (interosseous muscles of hand) at 4-5 injection sites in the dorsal surface of the hand.

pl-vegf165

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • obtained voluntary informed consent for participation in the clinical study
  • presence of systemic scleroderma features satisfied to criteria of American College of Rheumatology classification
  • presence at least one active digital ulcer at baseline

You may not qualify if:

  • presence of another systemic connective tissue disease;
  • absence at least one active digital ulcer at baseline;
  • smoking within 3 months or smoking cessation using nicotine products;
  • subjects currently taking sildenafil, tadalafil or vardenafil;
  • history of sympathectomy over previous 12 months
  • not able or unwilling to give voluntary informed consent for the study or follow requirements of the clinical study;
  • decompensated chronic visceral diseases;
  • clinically significant laboratory abnormalities;
  • HIV, HBV and HCV antibodies in serum;
  • alcohol or drug addiction;
  • participation in other clinical studies (or administration of study products) within 3 months prior the study;
  • conditions limiting study compliance (dementia, psycho-neurological diseases, drug addiction, alcoholism, etc.);
  • malignancies including post-surgical period with chemo- and (or) radiation therapy);
  • vascular malformations;
  • pregnancy or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Stem Cell Institute

Moscow, Russia

Location

MeSH Terms

Conditions

Raynaud DiseaseScleroderma, Systemic

Condition Hierarchy (Ancestors)

Livedoid VasculopathyThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesConnective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2015

First Posted

February 5, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2015

Study Completion

August 1, 2015

Last Updated

February 5, 2015

Record last verified: 2015-01

Locations

RU(1)