Open Label Immunotherapy of Endometriosis

Open Label, One-arm, 2-month Study of Once-daily Tablet of V-Endo as Immunotherapy of Endometriosis

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.

Study Overview

• Status: Unknown
• Conditions: Endometriosis
• Intervention / Treatment: Biological: V-Endo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mongolia
  • Ulaanbaatar, Mongolia
    • Recruiting
    • Immunitor LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 months
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/	2 months
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	2 months

Collaborators and Investigators

• Sponsor: Immunitor LLC
• Collaborators: Ekomed LLC
• Investigators: Study Chair: aldar bourinbaiar, MD/PhD, CEO

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 11, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 14, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: immunotherapy; infertility; inflammation; autoimmunity; pelvic pain
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: V-Endo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Once trial is terminated data will be available to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No