| CTRI Number |
CTRI/2023/06/054279 [Registered on: 21/06/2023] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To Evaluate Efficacy And Safety of Thymosin Alpha One Plus Standard of Care (SOC) in Comparison with SOC Alone in Patients with Confirmed Endometriosis. |
|
Scientific Title of Study
|
An Open Label, Multi-Center, Randomized, Two Arm, Phase III Clinical Trial to
Evaluate Efficacy and Safety of Thymosin alpha one plus Standard of Care (SOC) in Comparison
with SOC Alone in Patients with Confirmed Endometriosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GB_THY_003_22 _Version 3_27 OCT 2022 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr. Samveda Samel |
| Designation |
Manager Medical Affairs |
| Affiliation |
Gufic Biosciences Limited |
| Address |
Gufic Biosciences Limited Subhash Road A Block Vile Parle East Mumbai Maharashtra India 400057
Mumbai
MAHARASHTRA
400057
India |
| Phone |
9702002340 |
| Fax |
|
| Email |
dr.samveda.samel@guficbio.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Samveda Samel |
| Designation |
Manager Medical Affairs |
| Affiliation |
Gufic Biosciences Limited |
| Address |
Gufic Biosciences Limited Subhash Road A Block Vile Parle East Mumbai Maharashtra India 400057
MAHARASHTRA
400057
India |
| Phone |
9702002340 |
| Fax |
|
| Email |
dr.samveda.samel@guficbio.com |
|
Details of Contact Person
Public Query
|
| Name |
Vairamuthu Ammaiyappan |
| Designation |
Associate Director |
| Affiliation |
IDD Research Solutions INC |
| Address |
IDD Research Solutions INC First Floor 12A 19th Main Rd 3rd sector HSR Layout Bengaluru Karnataka 560102
Bangalore
KARNATAKA
560102
India |
| Phone |
9606829331 |
| Fax |
|
| Email |
Vairamuthu.ammaiyappan@iddresearch.com |
|
|
Source of Monetary or Material Support
|
| Gufic Biosciences Limited,
SM House, 11 Sahakar Road
Vile Parle East Mumbai, Maharashtra, India – 400057 |
|
|
Primary Sponsor
|
| Name |
Gufic Biosciences Limited |
| Address |
Gufic Biosciences Limited Subhash Road A Block Vile Parle East Mumbai Maharashtra India 400057 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mary Snygdha |
ACSR Govt Medical College and hospital |
Dargamitta G T Road Spsr Nellore 524004
Nellore
ANDHRA PRADESH
Nellore
ANDHRA PRADESH |
7660801861
doddaga.phaneendra@gmail.com |
| Dr Shyamala Kaitala |
King George Hospital Andhra Medical College |
King George Hospital Andhra Medical College Visakhapatnam Andhra Pradesh India 530002
Visakhapatnam
ANDHRA PRADESH |
9989453046
drkshyamalaresearch@gmail.com |
| Dr Rashmi Yogish |
Kushi IVF and Fertility Center |
Mohan Chambers Mini Forest Road After Valtech 31 1st Main Rd 3rd Phase J P Nagar Bengaluru Karnataka 560078
Bangalore
KARNATAKA |
9008692449
docrashmi@kushifertility.com |
| Dr Shabana Syed |
Nuha hospitals |
12 19 61 and 62 old bank road kothapet Guntur 522001
Guntur
ANDHRA PRADESH |
9985892627
drshabanasyed@gmail.com |
| Dr Rita bakshi |
RISAA IVF INTERNATIONAL FERTILITY CENTRE |
H 6 1st Floor Green Park Main Green Park New Delhi Delhi 110016
New Delhi
DELHI |
98101437303
ritabakshi.ifc@gmail.com |
| Dr Sneha sharad bhoir |
Vijay Vallabh hospital and medical research center |
Tirupati Nagar Rd beside Banjara Hotel Phase 1 Tirupati Nagar Virar West Virar Maharashtra 401303
Mumbai
MAHARASHTRA |
9022727123
snehabhoirmth@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ACSR-IEC |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE King George Hospital |
Approved |
| Institutional Ethics Committee of Nuha Hospitals |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE VIJAY VALLABH |
Approved |
| RISAA IVF ETHICS COMMITTE |
Approved |
| Science for Health Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D899||Disorder involving the immune mechanism, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SOC |
SOC will be administered as per investigator’s discretion. |
| Intervention |
Thymosin alpha one |
Thymosin alpha 1 with a dose 3.2 mg will be given to patient subcutaneous twice a week for a period of 3 Months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1. Female patients between the age group ≥18and ≤ 49 years of age at the time of
consent
2. Patients with a confirmed diagnosis of Endometriosis (up to stage III) based on
laparoscopy or imaging
3. Patients having negative urine pregnancy test at the time of screening and agree to
the use of barrier contraception during the study period
4. Patients who are willing to comply with study procedures and restrictions
5. Patients who can and are willing to provide signed informed consent |
|
| ExclusionCriteria |
| Details |
1. Patient with a surgical history of hysterectomy, bilateral adnexectomy, endometrial
ablation resulting in amenorrhea
2. Candidate for elective gynaecological surgery [Dilation and Curettage (D&C),
cervical cryosurgery, colposcopy, Loop Electrosurgical Extension Procedure
(LEEP)] for next 6 months
3. Patient who had a normal or C section delivery with a gap of less than 3 months
after cessation of Lactation
4. Participation in other clinical trials in last three months and during study period
5. Patients having an unstable medical condition or chronic disease (including history
of neurological [including cognitive], hepatic, renal, cardiovascular,
gastrointestinal, pulmonary, or endocrine disease), or malignancy that could
confound interpretation of the study outcomes
6. Patients having a history of positive human immunodeficiency virus antibody (HIV
Ab), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV-Ab)
assay at Screening or have a history of a positive result
7. Pregnant and lactating female lactating at the time of screening and willing to
continue lactating during the study
8. Any other condition, which as per the investigator would jeopardize the outcome of
the trial
9. Patients who, in the judgment of the investigator, will be unlikely to comply with
the requirements of this protocol |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the efficacy of Thymosin α 1 in
combination with SOC versus SOC alone in patients with
endometriosis in terms of endometriosis associated pain assessed by a
Visual Analogue Scale (VAS) score |
Day -2, Day 1, Day 30, Day 45, Day 60, Day 90, Day 135, Day 180 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To evaluate and compare the efficacy of Thymosin α 1 in
combination with SOC versus SOC alone in patients with
endometriosis in terms of Dysmenorrhea (DYS) pain scale score,
Dyspareunia (DYSP) pain scale score, Non-Menstrual Pelvic Pain
(NMPP) pain scale, lower back pain, dyschezia related pain on NRS,
and overall size of Endometriosis.
• To assess and compare the safety of Thymosin α 1 in combination
with SOC versus SOC alone. |
Day 1, Day 30, Day 60, Day 90, Day 135 and Day 180 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
17/07/2023 |
| Date of Study Completion (India) |
15/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Endometriosis is defined as the presence of endometrial glands and stroma-like lesions outside of the uterus The cause of endometriosis is still unclear but an increasing number of studies have been investigated the role of immune system in its etiology and pathogenesis Thymosin α 1 has a wide range of biological activities that range from anti-tumor to immune- modulating properties. Thymosin α 1 looks a potential treatment that can be dosed in combination with standard of care in patients with endometriosis Total 120 Eligible patients will be enrolled in 1:1 ratio in two arms ( 60 Patients in each arm) 90 days for treatment and another 90 days for follow up |