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Open Label Immunotherapy of Endometriosis

Primary Purpose

Endometriosis

Status
Unknown status
Phase
Phase 2
Locations
Mongolia
Study Type
Interventional
Intervention
V-Endo
Sponsored by
Immunitor LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring inflammation, autoimmunity, immunotherapy, infertility, pelvic pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • age between 18 and 50 years
  • pain visual analog scale (VAS) score over 4 (visual linear scale from 0 to 10)
  • confirmation of endometriosis by laparoscopy
  • no drugs used at least for one month prior to enrollment, i.e., estro-progestinic, progestinic, gonadotropin-releasing hormone (GnRH) agonists and antagonists as well as nonsteroidal anti-inflammatory drugs (NSAIDs)

Exclusion Criteria:

  • presence of other associated diseases such as malignancies
  • concomitant use of hormonal drugs
  • menopause
  • pregnancy
  • surgery for endometriosis within the last month prior to study entry
  • unable or unwilling to give written consent patients
  • adverse reaction or hypersensitivity to active substance or excipients of V-Endo

Sites / Locations

  • Immunitor LLCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

One arm open label V-Endo recepients

Arm Description

This is single arm open label trial wherein active drug is V-Endo

Outcomes

Primary Outcome Measures

Effect on pelvic pain by visual analogue scale (VAS)
The pain VAS is a continuous scale comprised of a horizontal or vertical line, usually 10 centimeters (100 mm) in length. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).

Secondary Outcome Measures

Effect of V-Endo on complete blood count (CBC)
The effect of V-Endo on complete blood cell count and clinical biochemistry will be evaluated by routine lab tests to determine whether they are within normal ranges are as described in http://onlinelibrary.wiley.com/doi/10.1002/9781118704783.app3/pdf
Changes induced By V-Endo on life quality
Changes in life quality occurring as a result of intervention as measured by EHP-30 instrument https://innovation.ox.ac.uk/outcome-measures/endometriosis-health-profile-ehp/
Effect of V-Endo liver and kidney biochemistry parameters
The influence on kidney and liver biochemistry parameters measured as described in http://onlinelibrary.wiley.com/doi/10.1002/9781118704783.app3/pdf

Full Information

First Posted
October 11, 2017
Last Updated
April 14, 2019
Sponsor
Immunitor LLC
Collaborators
Ekomed LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03340324
Brief Title
Open Label Immunotherapy of Endometriosis
Official Title
Open Label, One-arm, 2-month Study of Once-daily Tablet of V-Endo as Immunotherapy of Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunitor LLC
Collaborators
Ekomed LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Endometriosis is a chronic gynecological disease characterized by sustained painful symptoms that are responsible for a decline in the quality of life of sufferers. Endometriosis is fairly common, affecting an estimated 10%-15% of women and girls, usually during their reproductive years. Based on these rough estimates, the latest epidemiological studies suggest that over 200 million women are might be affected who may commonly have infertility problems. Additionally, endometriosis is a major factor increasing by 33-66% risk of ovarian cancer. V-Endo is a tableted preparation derived from hydrolyzed, heat-inactivated, pooled blood of women with endometriosis. When taken orally it is postulated to cause the immune tolerance and anti-inflammatory effect as a result.
Detailed Description
Anatomically endometriosis is characterized by the presence of endometrial-type mucosa outside the uterine cavity. This tissue proliferates and causes chronic inflammation resulting in pain and excessive menstrual bleeding. Conventional treatment includes surgical and pharmacological therapy aiming at reducing painful symptoms. However, there is an unmet need in finding optimally safe and effective treatment. This study aimed to evaluate the effect of V-Endo on pain levels in women with endometriosis, focusing on reducing inflammation by immunotherapeutic intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
inflammation, autoimmunity, immunotherapy, infertility, pelvic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
open-label, single arm study
Masking
None (Open Label)
Masking Description
no masking
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
One arm open label V-Endo recepients
Arm Type
Experimental
Arm Description
This is single arm open label trial wherein active drug is V-Endo
Intervention Type
Biological
Intervention Name(s)
V-Endo
Intervention Description
V-Endo is a tableted immunotherapeutic derived from hydrolyzed, heat-inactivated, pooled blood from women with endometriosis
Primary Outcome Measure Information:
Title
Effect on pelvic pain by visual analogue scale (VAS)
Description
The pain VAS is a continuous scale comprised of a horizontal or vertical line, usually 10 centimeters (100 mm) in length. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Effect of V-Endo on complete blood count (CBC)
Description
The effect of V-Endo on complete blood cell count and clinical biochemistry will be evaluated by routine lab tests to determine whether they are within normal ranges are as described in http://onlinelibrary.wiley.com/doi/10.1002/9781118704783.app3/pdf
Time Frame
2 months
Title
Changes induced By V-Endo on life quality
Description
Changes in life quality occurring as a result of intervention as measured by EHP-30 instrument https://innovation.ox.ac.uk/outcome-measures/endometriosis-health-profile-ehp/
Time Frame
2 months
Title
Effect of V-Endo liver and kidney biochemistry parameters
Description
The influence on kidney and liver biochemistry parameters measured as described in http://onlinelibrary.wiley.com/doi/10.1002/9781118704783.app3/pdf
Time Frame
2 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only females will be enrolled as only they have endometriosis
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age between 18 and 50 years pain visual analog scale (VAS) score over 4 (visual linear scale from 0 to 10) confirmation of endometriosis by laparoscopy no drugs used at least for one month prior to enrollment, i.e., estro-progestinic, progestinic, gonadotropin-releasing hormone (GnRH) agonists and antagonists as well as nonsteroidal anti-inflammatory drugs (NSAIDs) Exclusion Criteria: presence of other associated diseases such as malignancies concomitant use of hormonal drugs menopause pregnancy surgery for endometriosis within the last month prior to study entry unable or unwilling to give written consent patients adverse reaction or hypersensitivity to active substance or excipients of V-Endo
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aldar Bourinbaiar, MD/PhD
Phone
+976 95130306
Email
aldar@immunitor.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Tarakanovskaya, MD
Phone
1 3014760930
Email
marinatarakanovskaya@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
aldar bourinbaiar, MD/PhD
Organizational Affiliation
CEO
Official's Role
Study Chair
Facility Information:
Facility Name
Immunitor LLC
City
Ulaanbaatar
Country
Mongolia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aldar Bourinbaiar, MD
Phone
97695130306
Email
aldar@immunitor.com
First Name & Middle Initial & Last Name & Degree
Marina Tarakanovskaya, MD
Email
marinatarakanovskaya@yahoo.com
First Name & Middle Initial & Last Name & Degree
Galyna Kutsyna, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Once trial is terminated data will be available to share

Learn more about this trial

Open Label Immunotherapy of Endometriosis

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