| CTRI Number |
CTRI/2025/08/093298 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Hormone therapy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Evaluate the dose and Safety of purified Human Chorionic Gonadotropin (hCG) injection in Patients with post bone marrow transplant Acute Graft-versus-Host Disease |
|
Scientific Title of Study
|
An Open-label, Single-arm, Phase-1 Clinical study to evaluate the safety of purified
Human Chorionic Gonadotrophin in patients with acute Graft vs Host disease |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Talasila Naga Bhavani Krishna |
| Designation |
Senior Resident |
| Affiliation |
All india institute of medical sciences |
| Address |
DR BRA Institue cancer rotary hospital
Ansari Nagar east AIIMS new delhi 110029
South
DELHI
110029
India |
| Phone |
9177833821 |
| Fax |
0 |
| Email |
bhavanitalasila0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ranjit Kumar Sahoo |
| Designation |
Professor |
| Affiliation |
All india institute of medical sciences |
| Address |
Room:218, second floor,DR BRA Institue cancer rotary hospital
Ansari Nagar east AIIMS new delhi 110029
South
DELHI
110029
India |
| Phone |
9013956187 |
| Fax |
0 |
| Email |
drranjitmd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Talasila Naga Bhavani Krishna |
| Designation |
Senior Resident |
| Affiliation |
All india institute of medical sciences |
| Address |
DR BRA Institue cancer rotary hospital
Ansari Nagar east AIIMS new delhi 110029
South
DELHI
110029
India |
| Phone |
9177833821 |
| Fax |
0 |
| Email |
bhavanitalasila0@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aiims institute research fund
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
ANSARI NAGAR, NEW DELHI-110029, INDIA |
|
|
Primary Sponsor
|
| Name |
All India Institute of medical sciences |
| Address |
Aiims new delhi ansari nagar east 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrTNBhavani krishna |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Department of Medical Oncology,Dr.BR AMBEDKAR INSTITUTE ROTARY CANCER HOSPITAL,
Ansari Nagar,New Delhi 110029
South
DELHI |
9177833821
bhavanitalasila0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for Post graduate Research, All India Institute Of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D898||Other specified disorders involving the immune mechanism, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug purified human chorionic gonadotrophin |
Subcutaneous injection, every alternate day total 7 doses followed by twice weekly maintenance |
| Comparator Agent |
Single arm not applicable |
Single arm not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of Grade II or more GVHD
AGE 18 to 65 |
|
| ExclusionCriteria |
| Details |
Patients with thrombosis within 3 months of starting the study, a current
thromboembolic disease requiring full dose anticoagulation.
c)
Progressive malignancy
d)
Previous diagnosis of hormone-responsive malignancy
e) Pregnancy
f) Uncontrolled infection at the initiation of protocol |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the toxicity and maximum tolerated dose of purified human chorionic gonadotrophin |
toxicity assessment will be ongoing for 8 weeks post first injection. visits are scheduled on Day 4,7, 14, 28, 56. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of HCG(purified) & proportional response among patients |
response to therapy on day7, day 14, day 28, day 56 as compared to baseline |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
08/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="23" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Human chorionic Gonadotrophin is nature’s anti-rejection agent. In normal pregnancy regulatory T-cells are increased in number both at the fetal-maternal interface and in the peripheral blood due to HCG[7]. Commercially available urinary hcg are also sources of Epidermal Growth Factor(EGF)[8]. In pre-clinical models of intestinal damage due to radiation use, EGF has been shown to enhance gut epithelial regeneration and protect against the development of colitis[9]. Two studies are available with the use of HCG in GVHD one of them is a pilot study with the use of low-dose HCG and the other is a phase-1/2 study by et al which determined a maximum tolerated dose of 2000U/m².In the phase-2 study by Holton et al even though their pre-determined dose in phase-1 is 2000IU/m²they have used 5000 IU/m²in cases of steroid refractory GVHD as the EGF response was inadequate. In two other pilot studies[10], [11] in oncology where uHCG is used for immunomodulation doses used were 10,000 IU i.m, daily for 8 weeks, 1- 3,00,000 IU for 3-4 weeks with no serious adverse events.Hence there is a need for a well-structured dose-finding study for the optimal use of the therapeutic effect of uHCG. |