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Open Label Immunotherapy of Endometriosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03340324
Recruitment Status : Unknown
Verified April 2019 by Immunitor LLC.
Recruitment status was:  Recruiting
First Posted : November 13, 2017
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Ekomed LLC
Information provided by (Responsible Party):
Immunitor LLC

Tracking Information
First Submitted Date  ICMJE October 11, 2017
First Posted Date  ICMJE November 13, 2017
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE October 1, 2017
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
  • 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
  • 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/
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Immunotherapy of Endometriosis
Official Title  ICMJE Open Label, One-arm, 2-month Study of Once-daily Tablet of V-Endo as Immunotherapy of Endometriosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
open-label, single arm study
Masking: None (Open Label)
Masking Description:
no masking
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE Biological: V-Endo
V-Endo is a tableted immunotherapeutic derived from hydrolyzed, heat-inactivated, pooled blood from women with endometriosis
Study Arms  ICMJE Experimental: One arm open label V-Endo recepients
This is single arm open label trial wherein active drug is V-Endo
Intervention: Biological: V-Endo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 8, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Only females will be enrolled as only they have endometriosis
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mongolia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03340324
Other Study ID Numbers  ICMJE V-Endo
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Once trial is terminated data will be available to share
Current Responsible Party Immunitor LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Immunitor LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Ekomed LLC
Investigators  ICMJE
Study Chair: aldar bourinbaiar, MD/PhD CEO
PRS Account Immunitor LLC
Verification Date April 2019

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