| CTRI Number |
CTRI/2025/07/090752 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A open label study to assess the efficacy of Injection sovateltide in patients with Elephantiasis. |
|
Scientific Title of Study
|
A prospective, open-label study to assess the efficacy of sovateltide
in filariasis patients with lower limb lymphedema |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Sovateltide/LF/2025, Version, No. 1.0, Date: 30 APR 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Manoj Kumar Pal |
| Designation |
Principal Investigator |
| Affiliation |
Janta Hospital and Maternity Center |
| Address |
Janta Hospital and Maternity Center,
OPD Room No. 1, Ground Floor, Near Water Head Tank,
Amara Akhari Bypass,
Chunar Road.
Varanasi
UTTAR PRADESH
221011
India |
| Phone |
9198677778 |
| Fax |
|
| Email |
manojpalvns@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Kumar Pal |
| Designation |
Principal Investigator |
| Affiliation |
Janta Hospital and Maternity Center |
| Address |
Janta Hospital and Maternity Center,
OPD Room No.1,Ground Floor,
Near Water Head Tank,
Amara Akhari Bypass
Chunar Road
Varanasi
UTTAR PRADESH
221011
India |
| Phone |
9198677778 |
| Fax |
|
| Email |
manojpalvns@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj Kumar Pal |
| Designation |
Principal Investigator |
| Affiliation |
Janta Hospital and Maternity Center |
| Address |
Janta Hospital and Maternity Center,
OPD Room No.1,Ground Floor,
Near Water Head Tank,
Amara Akhari Bypass,
Chunar Road
Varanasi
UTTAR PRADESH
221011
India |
| Phone |
9198677778 |
| Fax |
|
| Email |
manojpalvns@gmail.com |
|
|
Source of Monetary or Material Support
|
| Janta Hospital and Maternity Center |
|
|
Primary Sponsor
|
| Name |
Janta Hospital and Maternity Center, |
| Address |
Near Water Head Tank, Amara Akhari Bypass,
Chunar Road, Varanasi-221011, UP, India
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Dr Manoj Kumar Pal |
Janta Hospital and Maternity Center |
OPD Room No.1,Ground Floor, Near Water Head Tank, Amara Akhari Bypass,
Chunar Road, Varanasi-221011, India
Varanasi
UTTAR PRADESH |
9198677778
manojpalvns@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ford Hospital, Ethics Committee, Balaji Colony, Samneghat, Lanka Varanasi, Uttar Pradesh, 221005 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B948||Sequelae of other specified infectious and parasitic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Sovateltide |
Sovateltide will be administered at a dose of 0.3
mcg per kg as an IV bolus over 1 minute at every 3 hours on days 1, 3, and 6. Total dose per day: 0.9 mcg per kg. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult male or female aged 18 to 80 years
2. Patient or his and her Legally Acceptable Representative willing to give informed consent before the study procedure.
3. Clinical diagnosis of lymphatic filariasis with WHO Stage 2 or 3 lower limb lymphedema
4. Ability to comply with study procedures |
|
| ExclusionCriteria |
| Details |
1. Pregnancy or breastfeeding
2. History of malignancy or significant immunological disorders
3. Recent limb surgery or trauma, or a candidate for any surgical
intervention during the study duration.
4. Evidence of any other major life threatening or serious medical
condition, such as severe renal, hepatic, and cardiovascular
disease, which would prevent completion of the study protocol,
impair the assessment of outcome, or in which sovateltide therapy
would be contraindicated or might cause harm to the patient.
5. The patient is participating in another interventional study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of patients with at least a 25% reduction in a diseased limb volume from baseline to Day 28. |
From baseline to Day 28. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in the Functional mobility assessment
questionnaire for lower limb lymphoedema (LYMPH-ICF-LL) at
Day 28 compared to baseline |
From baseline to Day 28 |
Improvement in the Functional mobility assessment
questionnaire for lower limb lymphoedema (LYMPH-ICF-LL) at Day 28 compared to baseline |
From baseline to Day 28. |
Proportion of patients with adverse events (AEs) and serious
adverse events (SAEs) |
From baseline to Day 28 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/07/2025 |
| Date of Study Completion (India) |
17/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This is a Prospective, open-label clinical study to assess the safety and efficacy of sovateltide in patients with filariasis-induced lower limb lymphedema. A total of 20 patients with Filariasisinduced lower limb lymphedema will be enrolled in this study
The enrolment period of the study will be approximately 3 months, and the total duration of the study will be approximately 6 months. For an individual patient, the duration of the study will be 28 days, including 2 study visits: visit 1 and visit 2. A total of 20 patients will be enrolled in the study after meeting the eligibility criteria
Treatment of enrolled subject: Sovateltide along with Standard of Care
All patients enrolled in this study will receive sovateltide in addition to the standard of care for lymphatic filariasis. Sovateltide will be administered at a dose of 0.3 mcg per kg as an IV bolus over 1 minute at every 3 hours of interval on days 1, 3, and 6. Each patient will be monitored closely throughout the study duration from randomization and will be assessed for efficacy and safety parameters over 28 days from randomization at a clinic visit. |