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Open Label Immunotherapy of Endometriosis

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ClinicalTrials.gov Identifier: NCT03340324
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Ekomed LLC
Information provided by (Responsible Party):
Immunitor LLC

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.

Condition or disease Intervention/treatment Phase
Endometriosis Biological: V-Endo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: open-label, single arm study
Masking: None (Open Label)
Masking Description: no masking
Primary Purpose: Treatment
Official Title: Open Label, One-arm, 2-month Study of Once-daily Tablet of V-Endo as Immunotherapy of Endometriosis
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: One arm open label V-Endo recepients
This is single arm open label trial wherein active drug is V-Endo
Biological: V-Endo
V-Endo is a tableted immunotherapeutic derived from hydrolyzed, heat-inactivated, pooled blood from women with endometriosis




Primary Outcome Measures :
  1. Effect on pelvic pain by visual analogue scale (VAS) [ Time Frame: 2 months ]
    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 :
  1. Effect of V-Endo on complete blood count (CBC) [ Time Frame: 2 months ]
    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

  2. Changes induced By V-Endo on life quality [ Time Frame: 2 months ]
    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/

  3. Effect of V-Endo liver and kidney biochemistry parameters [ Time Frame: 2 months ]
    The influence on kidney and liver biochemistry parameters measured as described in http://onlinelibrary.wiley.com/doi/10.1002/9781118704783.app3/pdf



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only females will be enrolled as only they have endometriosis
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340324


Contacts
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Contact: Aldar Bourinbaiar, MD/PhD +976 95130306 aldar@immunitor.com
Contact: Marina Tarakanovskaya, MD 1 3014760930 marinatarakanovskaya@yahoo.com

Locations
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Mongolia
Immunitor LLC Recruiting
Ulaanbaatar, Mongolia
Contact: Aldar Bourinbaiar, MD    97695130306    aldar@immunitor.com   
Contact: Marina Tarakanovskaya, MD       marinatarakanovskaya@yahoo.com   
Principal Investigator: Galyna Kutsyna, MD         
Sponsors and Collaborators
Immunitor LLC
Ekomed LLC
Investigators
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Study Chair: aldar bourinbaiar, MD/PhD CEO

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Responsible Party: Immunitor LLC
ClinicalTrials.gov Identifier: NCT03340324     History of Changes
Other Study ID Numbers: V-Endo
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Once trial is terminated data will be available to share

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Immunitor LLC:
inflammation
autoimmunity
immunotherapy
infertility
pelvic pain

Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female