| CTRI Number |
CTRI/2009/091/000283 [Registered on: 06/11/2009] |
| Last Modified On: |
20/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Preventive |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
Study to evaluate the safety and efficacy of TULY (rasburicase) in prevention and treatment of malignancy-associated hyperuricemia |
Scientific Title of Study
Modification(s)
|
Efficacy and safety of TULY (rasburicase) in prevention and treatment of malignancy-associated hyperuricemia - An open-label, multicentre study in India. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT00921375 |
ClinicalTrials.gov |
| VB037 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Raghunadharao |
| Designation |
Prinicipal Investigator |
| Affiliation |
Nizams Institute Of Medical Sciences |
| Address |
Professor & Head of Dept. of Medical Oncology
Nizams Institute Of Medical Sciences (NIMS)
Hyderabad
ANDHRA PRADESH
500 082
India |
| Phone |
91-40-23371747 |
| Fax |
|
| Email |
draghu_hyd@dataone.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Hemanth Nandigala |
| Designation |
Executive Director (Comm) |
| Affiliation |
Virchow Biotech Pvt Ltd |
| Address |
Virchow Biotech Pvt Ltd
Virchow Biotech(P) Ltd
# 319 & 320,3rd floor,
Swamy Ayyapa Co-op,Housing society Ltd.
Madhapur
Hyderabad
ANDHRA PRADESH
500 081
India |
| Phone |
91-40-23119481 |
| Fax |
91-40-23119486 |
| Email |
hemanth@virchows.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Hemanth Nandigala |
| Designation |
Executive Director (Comm) |
| Affiliation |
Virchow Biotech Pvt Ltd |
| Address |
Virchow Biotech Pvt Ltd
Virchow Biotech(P) Ltd
# 319 & 320,3rd floor,
Swamy Ayyapa Co-op,Housing society Ltd.
Madhapur
Hyderabad
ANDHRA PRADESH
500 081
India |
| Phone |
91-40-23119481 |
| Fax |
91-40-23119486 |
| Email |
hemanth@virchows.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Virchow Biotech Pvt Ltd
Virchow Biotech Private Limited
F.No: 319 & 320, 3rd Floor,
Swamy Ayyappa Housing Society
Madhapur, Hyderabad – 500 081
Ph: 040-23119481/64581006
|
|
Primary Sponsor
Modification(s)
|
| Name |
Virchow Biotech Pvt Ltd |
| Address |
Virchow Biotech(P) Ltd
# 319 & 320,3rd floor,
Swamy Ayyapa Co-op,Housing society Ltd.
Madhapur,Hyderabad -500081. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudha Sinha MD |
MNJ Institute of Oncology and Regional Cancer Center |
Red Hills, Lakadikapul,
Hyderabad 500004
AP - INDIA
Rangareddi
ANDHRA PRADESH |
040-23318422
sudhasinha@hotmail.com |
| Dr Shekar Patil MD DM |
1. Bangalore Institute of Oncology |
No 44-45/2, 2nd Cross,
Raja Rammohan Roy Extension
(Off. Lalbagh Double Road)
Bangalore – 560027
Bangalore
KARNATAKA |
91-80-40206400
shashidharahp@rediffmail.com |
| Dr Nirini MD IntMed DM HematoOnco |
4. Indo-American Cancer Institute and Research Center |
Road No 14, Banjara Hills, Hyderabad, 500034
Hyderabad
ANDHRA PRADESH |
91-40-23551235
nirni2002@rediffmail.com |
| DrPRavi Mohan MDDM |
5. King George Hospital, Andhra Medical College |
Jagadamba Area, KGH Down Rd, Maharani Peta, Visakhapatnam, 530002
Visakhapatnam
ANDHRA PRADESH |
0891-2712755
amconcology@hotmail.com |
| Dr Raghunadha rao MD DM |
NIMS Hospital |
Punjagutta, Hyderabad 500034
Hyderabad
ANDHRA PRADESH |
91-40-23489000
draghu_hyd@dataone.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| 1. NIZAM’S Institute of Medical Sciences |
Approved |
| HCG - Centeral Ethics Committee |
Approved |
| IEC - Indo American Cancer Institute and Reserach Center |
Approved |
| IEC-KGH |
Approved |
| MNJ Institute of Oncology and Regional Cancer Center |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
TULY (rasburicase) |
TULY (rasburicase)0.20 mg/kg body weight intravenously for daily once for 4 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
1.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of both genders aged between 1 to 75 years;
2.Patients with stage III or IV non-Hodgkin lymphoma (NHL) or acute lymphoblastic leukemia (ALL) with a peripheral WBC count of >25,000/µL or any leukemia or lymphoma with plasma uric acid level of at least 8 mg/dL;
3.Eastern Cooperative Oncology Group (ECOG) performance scale of ≤3;
4.Patients scheduled to receive chemotherapy;
|
|
| ExclusionCriteria |
| Details |
1.Patients with allergy or asthma, or hypersensitivity to urate oxidase, or hemolytic reactions;
2.Pregnant and lactating;
3.Patients with glucose-6-phosphate dehydrogenase deficiency;
4.Exposure to rasburicase or allopurinol within 7 days;
5.History of psychiatric or co-morbid unstable medical conditions
|
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy;
2. Plasma uric acid AUC 0-96 hr;
3. Incidence of adverse events.
|
At the end of 4 hrs after initiation of uric acid lowering therapy;
During 96 hrs of uric acid lowering therapy;
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Nil |
|
| Plasma uric acid AUC0-96 hr |
from 0 to 4 days |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
22/02/2010 |
| Date of Study Completion (India) |
02/01/2012 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Digumarti R, Sinha S, Nirni SS, Patil SG, Pedapenki RM.Efficacy of rasburicase (recombinant urate oxidase) in the prevention and treatment of malignancy-associated hyperuricemia: An Indian experience. Indian J Cancer. 2014 Apr-Jun;51(2):180-3. doi: 10.4103/0019-509X.138299. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a prospective, open-label, multicentre study. Hundred eligible patients with stage III or IV non-Hodgkin lymphoma (NHL) or acute lymphoblastic leukemia (ALL) with a peripheral WBC count of >25,000/µL or any leukemia or lymphoma with plasma uric acid level of at least 8 mg/dL will be treated with rasburicase 0.20 mg/kg body weight intravenously for 4 days. The primary endpoints viz., the percentage of reduction in plasma uric acid at 4 hrs after uric acid-lowering therapy, plasma uric acid AUC 0-96 hr and incidence of adverse events will be assessed during 11 days study period. |