| CTRI Number |
CTRI/2025/07/090325 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
RABI-767 EUS-guided injection in the treatment of a patient with Acute Pancreatitis. |
|
Scientific Title of Study
|
A Phase 2a, Multi-Center, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of a Single Dose of RABI-767 Administered by Endoscopic Ultrasound-Guided Peripancreatic Injection Plus Standard-of-Care Versus Standard-of-Care Only in Participants with Predicted Severe Acute Pancreatitis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT06080789 |
ClinicalTrials.gov |
| RABI-767-201, Version No. 4.0, Dated: 10 Feb 2025 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr. Neeraj Prasad |
| Designation |
Deputy Director – Operations |
| Affiliation |
JSS Medical Research Asia Pacific Private Limited |
| Address |
Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no. 12/4, Sector 27D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad-, Haryana, India
Faridabad
HARYANA
121003
India |
| Phone |
9930740633 |
| Fax |
|
| Email |
neeraj.prasad@jssresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonika Newar |
| Designation |
General Manager - Medical Monitoring and Safety |
| Affiliation |
JSS Medical Research Asia pacific Private Limit |
| Address |
JSS Medical Research Asia Pacific Private Limited,
Tower 2, 1st Floor, South Wing, L&T Business Park,
Faridabad
HARYANA
121003
India |
| Phone |
08800799887 |
| Fax |
91 129 6613520 |
| Email |
Sonika.newar@jssresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramprasath T R |
| Designation |
Associate Director of Operations |
| Affiliation |
JSS Medical Research Asia Pacific Private Limited |
| Address |
Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no. 12/4, Sector 27D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad-, Haryana, India
Faridabad
HARYANA
121003
India |
| Phone |
9444101300 |
| Fax |
129 6613520 |
| Email |
ramprasath@jssresearch.com |
|
|
Source of Monetary or Material Support
|
| Panafina, Inc.
3000 RDU Center Drive, Suite 130, Morrisville, NC 27560-7643, USA
|
|
|
Primary Sponsor
|
| Name |
Panafina, Inc. |
| Address |
3000 RDU Center Drive, Suite 130, Morrisville, NC 27560-7643, USA
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| JSS Medical Research Asia Pacific Private Limited |
Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4, Sector 27 D, Delhi Mathura Road, Near Sarai Khawaja Metro Station, Faridabad -121003, Haryana, India
|
|
|
Countries of Recruitment
|
United States of America
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pramod Garg |
All India Institute of Medical Sciences |
Room No. – 3104
Floor No. – 3rd Floor, Teaching Block,
Department – Dept. of Gastroenterology,
Address –
All India Institute of Medical Sciences, Ansari Nagar,
New Delhi-110029-INDIA
New Delhi
DELHI |
9810038116
pgarg10@gmail.com |
| Dr Brij Sharma |
Atal Institute of Medical Super Specialties |
Room No. – 705
7th floor
Department of Gastroenterology, Atal Institute of Medical Super Specialties, Shimla, H. P. -171006 India
Shimla
HIMACHAL PRADESH |
9418587487
drbrijsharma01@gmail.com |
| Dr Reuben Thomas Kurien |
Christian Medical College, Vellore |
Room No. – A Block
Floor No. – 7th Floor, Dept. of Gastroenterology, Christian Medical College, Vellore, Ranipet Campus, Kalminnal Village, Ranipet – 632517, Tamil Nadu
Vellore
TAMIL NADU |
9443136437
reubenthomask@gmail.com |
| Dr Siddharth Srivastava |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research
1-Jawahar Lal Nehtu Marg, New Delhi-110002, Delhi
New Delhi
DELHI |
0112323 3001
docsiddharth1@gmail.com |
| Dr Mathew Philip |
Lisie Hospital |
Room No. - 2059, Ground Floor, St. Augustin Block, Department of Gastroenterology Lisie Hospital P. O Box No. 3053, Kathrikadavu, Kochi Kerala, India – 682018
Ernakulam
KERALA |
9072214094
drmathewphilip@gmail.com |
| Dr Jayanta Samanta |
Post Graduate Institute of Medical Education and Research (PGIMER) |
Room No. – Not Applicable
Floor No. - Ground Floor
Department of Gastroenterology Nehru Hospital, F-Block, PGIMER Chandigarh, Madhya Marg, Sector 12, Chandigarh, 160012
Chandigarh
CHANDIGARH |
9855319529
dj_samanta@yahoo.co.in |
| Dr K K Rawal |
Prime Hospital Institutional Ethics committee |
Room No. – 408
Fourth Floor
Department of Gastroenterology
Direct Prime Institute of Digestive Sciences Pvt. Ltd. Panchavati Main Society Road, Atithi Chowk, Beside Chandresh Vadi, Nana Mava Road, Rajkot, Gujarat India – 360001
Rajkot
GUJARAT |
7284000108
kkrawal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| - Institutional review board christian medical college thorapadi post bagayam vellore vellore tamil nadu - 632012 india |
Approved |
| Institute Ethics Committee All India Institute of Medical Sciences Ansari Nagar, New Delhi-29 New Delhi |
Approved |
| Institutional Ethics Committee IGMC Shimla Indira Gandhi Medical College Shimla |
Submittted/Under Review |
| Institutional Ethics committee MAMC , Maulana Azad Medical College ,3rd floor room No -306A ,Bahadur Shah Zafar Marg Delhi ,New delhi -110002 |
Approved |
| Institutional Ethics Committee Post Graduate Institute of Medical Education and Research P N Chuttani Block Chandigarh -160012 India |
Approved |
| Institutional Ethics Committee, Lisie Hospital Lisie Hospital P.B No 3053 Ernakulam Ernakulam Kerala - 682018 India |
Approved |
| Prime Hospital Institutional Ethics committee Prime Institute Of Digestive Science LLP |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K859||Acute pancreatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
RABI-767 |
Dosage Form- Suspension for Injection
Dose: Single dose of 125 mg (25 mL of 5 mg/mL) RABI-767
Route of Administration: Endoscopic ultrasound-guided fine-needle peripancreatic injection into the retroperitoneal cavity |
| Comparator Agent |
Standard Treatment |
Group 2 will use standard treatment for the study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of current acute pancreatitis
Adults 18-85 years of age.
Predicted severe acute pancreatitis, based on protocol-defined criteria.
Lack of clinically meaningful improvement from status at admission, at the discretion of Investigator, at the time of randomization
Suitable for EUS-guided study drug administration procedure
Contrast-enhanced computed tomography (CECT) or magnetic resonance imaging (MRI) of the abdomen/pancreas available for the evaluation of exclusion criteria
|
|
| ExclusionCriteria |
| Details |
Confirmed severe acute pancreatitis as defined by the Revised
Atlanta Classification of Acute Pancreatitis (ie, Persistent [48 hours] organ failure, per Modified Marshall Score), prior to randomization
Anticipated discharge from hospital within 48 hours of randomization
More than 30 percentage pancreatic necrosis on screening CECT or MRI
History of previous pancreatic necrosis, including necrosectomy
History of calcific chronic pancreatitis
Evidence of cholangitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety of a single dose of RABI-767 administered by EUS-guided peripancreatic injection plus standard-of-care versus standard-of-care only in adult participants with predicted severe acute pancreatitis. |
Day 28, Day 35, and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of a single dose of RABI-767 administered by EUS-guided peripancreatic injection plus standard-of-care versus standard-of-care only in adult participants with predicted severe acute pancreatitis; and
To determine plasma concentrations of RABI-767 following single-dose administration by EUS-guided peripancreatic injection in adult participants with predicted severe acute pancreatitis. |
Development of Severe Acute Pancreatitis from Day 1 to Day 28 (or hospital discharge, if earlier)
Development Moderately Severe Acute Pancreatitis from Day 1 to Day 28 (or hospital discharge, if earlier)
Mortality from Day 1 to Day 60 Follow-up, sub-grouped by mortality due to acute pancreatitis and/or related complications, and all-cause mortality.
Development of local complications (pseudocyst, walled off necrosis, etc), sub-grouped by type of complication from Day 1 to Day 60 Follow-up
Development of new or increased pancreatic necrosisfrom Day 1 to Day 60 Follow-up
Development of infection, sub-grouped by pancreatic, peripancreatic, and extra-pancreatic infections, Day 1 to Day 28 (or hospital discharge, if earlier).
Change from Baseline in Organ Dysfunction/Failure assessments (Modified Marshall and Sequential Organ Failure Assessment (SOFA) Score) from Day 1 to Day 28 (or hospital discharge, if earlier)
Change from Baseline in Systemic Inflammatory Response Syndrome (SIRS) assessments from Day 1 to Day 28 (or hospital discharge, if earlier)
Length of Hospital Stay (until medically eligible for discharge) from Day 1 to Day 28 (or hospital discharge, if earlier)
Re-hospitalization for acute pancreatitis or related complications from initial hospital discharge to Day 35 Follow-up
Change from Baseline in CT Severity Index (CTSI) and modified CTSI (mCTSI) scores and sub-scores (when post-baseline CECTs are performed) from Day 1 to Day 60 Follow-up
Change from Baseline in Abdominal Pain Numeric Rating Score from Day 1 to Day 28 (or hospital discharge, if earlier)
A total of 4 blood samples will be collected at the following time points and analyzed for plasma concentrations of RABI-767:
1 to 2 hours post-dose;
3 to 5 hours post-dose;
6 to 12 hours post-dose;
13 to 24 hours post-dose
|
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="18"
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 2 |
Date of First Enrollment (India)
Modification(s)
|
23/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 Phase 2a, multi-center, randomized, open-label, parallel-group study in adults with predicted severe acute pancreatitis to evaluate the safety and efficacy of a single dose of 125 mg (25 mL of 5 mg/mL) RABI-767 given by EUS-guided peripancreatic injection plus standard-of-care versus standard-of-care only. Study participants will be randomly assigned (like the flip of a coin) to receive a single dose of RABI-767 plus supportive care or supportive care only. All participants will be followed and study assessments recorded through Day 28 (± 1 day), or until hospital discharge, whichever occurs earlier. Two subsequent study follow-up study contacts will be completed on Day 35 (± 5 days) and Day 60 (± 7 days). Activities associated with this study, including screening and administration of study drug (if applicable), should not delay or preclude any aspect of standard-of-care in these participants. |