| CTRI Number |
CTRI/2009/091/000729 [Registered on: 18/09/2009] |
| Last Modified On: |
17/09/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the long term effects of Teplizumab in Children and Adults with Recent-Onset Type 1 Diabetes Mellitus |
|
Scientific Title of Study
|
A Multicenter, Multinational Extension of Study CP-MGA031-01 to Evaluate the Long-Term Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non -Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults with Recent -Onset Type 1 Diabetes Mellitus. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CP-MGA031-02 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
N/A
India |
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Darshana Dholakia |
| Designation |
Project Manager |
| Affiliation |
Project Manager, DiagnoSearch Life Sciences Pvt. Ltd. |
| Address |
DiagnoSearch Life Sciences Pvt. Ltd.
Unit No. 702, 7th Floor,
Dosti Pinnacle,
Plot No. E7, Road No. 22,
Wagle Industrial Estate,
Thane
MAHARASHTRA
400 604
India |
| Phone |
022-67776300 |
| Fax |
022-66754090 |
| Email |
darshana.dholakia@diagnosearch.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Darshana Dholakia |
| Designation |
Project Manager |
| Affiliation |
Employee of DiagnoSearch |
| Address |
DiagnoSearch Life Sciences Pvt. Ltd.
Unit No. 702, 7th Floor,
Dosti Pinnacle,
Plot No. E7, Road No. 22,
Wagle Industrial Estate,
Thane
MAHARASHTRA
400 604
India |
| Phone |
022-67776300 |
| Fax |
022-66754090 |
| Email |
darshana.dholakia@diagnosearch.com |
|
Source of Monetary or Material Support
Modification(s)
|
| MacroGenics, Incorporated
1500 East Gude Drive Rockville, Maryland 20850 USA
|
|
Primary Sponsor
Modification(s)
|
| Name |
MacroGenics Incorporated |
| Address |
MacroGenics, Incorporated
1500 East Gude Drive Rockville, Maryland 20850 USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 14 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Sunil Jain |
A unit of Diabetes Thyroid Hormone Research Institute Pvt Ltd |
BCM Health Island, PU4, Scheme 54, ,Behind Prestige Management Institute, Near Bombay Hospital-452010
Indore
MADHYA PRADESH |
91-079-2563183
91-731-2443250
sunilmjain@gmail.com |
| Dr. Monojit K Mukhopadhyay |
B. P. Poddar Hospital & Medical Research Limited |
71/1 Humayun Kabir Sarani,Block G (Near Durgapur Bridge)-700 053
Kolkata
WEST BENGAL |
91-33-24981213
91-33-24577009
mkmukhopadhyay@yahoo.co.in |
| Dr. K.M. Prasanna Kumar |
Banglore Diabetes Centre |
'Bangalore Diabetes centre,4C / 426, 2nd block, Kalyana Nagar-560043
Bangalore
KARNATAKA |
91-80 - 25902546
91-80-25425396
dr.kmpk@gmail.com |
| Dr. Sanjay Kalra |
Bharti Hospital |
Bharti Research Institute of Diabetes and Endocrinology Bharti Hospital,Wazir Chand Colony Kunjpura Road -132 001
Karnal
HARYANA |
91-184-2268484
91-184-2267885
brideknl@gmail.com |
| 11) Dr. Sanjeev Pathak |
DHL Research Centre |
DHL Research Centre 2nd Floor, Thakershy Trust Hospital,Opp V. M. Nagar Satellite-380015
Ahmadabad
GUJARAT |
91-79-26762564
91-79-26760646
medilinkresearch@yahoo.co.in |
| Dr. Nagajyothi Bodala |
DiabetOmics India Pvt. Ltd |
6-3-349/17B Hindi Nagar,,Behind Panjagutta Saibaba Temple Banjara Hills -500 034
Hyderabad
ANDHRA PRADESH |
91 40 65503111
91 40 23357111
jyothi.borra@gmail.com |
| Dr. Sujit Chandratreya |
Endocrine Clinic |
Mohini Raj,Ganga Pur Road-720500
|
91-253-3290783
91-253-2317466
sujitchandratreya@yahoo.com |
| 4) Dr. Shailesh Lodha |
Fortis Escorts Hospital |
Jawaharlal Nehru Marg,Malviya Nagar-302017
Jaipur
RAJASTHAN |
91-141 - 2547000
91-141-2547002
saileshlodha@yahoo.com |
| 8) Dr. Pramod Gandhi |
Gandhi Endocrinology and Diabetes Centre |
C-1 Srivardhan Complex,Wardha Road, Ramdas Peth-440010
Nagpur
MAHARASHTRA |
91-712-2460302
91-712-2463558
drpdgandhi1@yahoo.co.in |
| Dr Parag Shah |
Gujarat Endocrine Centre |
201, Silver Brook, B Block, Opp Doctor house,Near Parimal crossing, Alice Bridge-380006
Ahmadabad
GUJARAT |
91-79-26444222
91-79-26444222
paragendocrine@yahoo.com |
| 10) Dr. Subrahmanyam |
King George Hospital |
King George Hospital,Andhra Medical College-530 002
Visakhapatnam
ANDHRA PRADESH |
91-891-2508275
91-891-2508275
kavsendo@yahoo.co.in |
| 5) Dr. K.D. Modi |
Medwin Hospitals |
Raghav Ratna Towers,Chiragally Lane, Nampally-500001
Hyderabad
ANDHRA PRADESH |
91-40-23206666
91- 40- 66623441
drkdmodi@yahoo.co.in |
| 2) Dr. Richa Chaturvedi |
Pushpawati Singhania Research Institute |
Press Enclave Marg,Sheikh Sarai Phase II-110017
New Delhi
DELHI |
91-11 - 29250347
91-11 - 29250347
drrichaendo@rediffmail.com |
| 3) Dr. Uday Phadke |
Ruby Hall Clinic |
Grant Medical Foundation,40, Sassoon Road-411001
Pune
MAHARASHTRA |
91-20 - 26123391
91-20-26124529
uday.instride@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 14 |
| Name of Committee |
Approval Status |
| 2. Institutional Review Board, PSRI |
Approved |
| Astha Independent Ethics Comittee |
Approved |
| Central India Medical Research Ethics Committee. |
Approved |
| CLINICOM, Bangalore |
Approved |
| Ethical Committee of B.P.Poddar Hospital & Medical Research Ltd. |
Approved |
| Ethics Committee of Diabetes Thyroid Hormone Research Institute Pvt. Ltd., Indore. |
Approved |
| Gujarat Kidney Foundational Ethical Committee. |
Approved |
| Institutional Ethical Committee, Poona Medical Research foundation |
Approved |
| Institutional Ethics Committee for B.R.I.D.E (Bharati Research Institute of Diabetes and Endocrinology) |
Approved |
| Institutional Ethics Committee, Fortis Escorts Hospital. |
Approved |
| Institutional Ethics Committee, King George Hospital |
Approved |
| Institutional Ethics Committee, Medwin Hospitals. |
Approved |
| Institutional Ethics Committee, Shatabdi Super specialty Hospital |
Approved |
| Medisys Clinisearch Ethical Review Board, Bangalore. |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Recent Onset of Type 1 Diabetes Mellitus, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Teplizumab (MGA031) |
None |
|
Inclusion Criteria
Modification(s)
|
| Age From |
8.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects must meet all of the following criteria to participate in the extension study: Complete Protocol CP-MGA031-01 (i.e., all subjects who complete Study Day 728, regardless of how many doses of study drug are received).
2. Provide written informed consent. Written assent will be obtained for subjects under 18 years of age, according to applicable regulations. If possible, written informed consent and/or assent should be obtained for Protocol CP-MGA031-02 at the last visit in CP¬MGA031-01 . The investigator is to give the subject ample time to decide about participation
|
|
| ExclusionCriteria |
| Details |
There are no exclusion criteria for this extension study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of the extension study is to assess long-term safety, with particular focus on the development of serious adverse events (SAEs), adverse events of special interest (AESIs) including opportunistic infections and lymphoproliferative disease, and other immediately reportable events (IREs), in subjects with recent-onset T1DM who complete CP-MGA031-01. |
Not Applicable |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objectives of the extension study are:
1) A secondary endpoint will be determining the efficacy of teplizumab by measuring the subject's total daily insulin usage and HbA1c levels.
2) C-peptide secretory response will be analyzed in terms of basal levels of C-peptide produced before a mixed meal and stimulated levels after a mixed meal, measured as AUC and peak post-meal production.
3) Immunophenotyping of blood mononuclear cells will be summarized by visit and graphed over time, as appropriate.
4) Assessing Heath Related Quality of Life Questionnaires filled out by subjects at different timepoints in the study.
|
Not Applicable |
|
Target Sample Size
Modification(s)
|
Total Sample Size="538"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
29/09/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
14/02/2009 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary objective of the extension study is to assess long-term safety (3 years), with particular focus on the development of serious adverse events (SAEs), adverse events of special interest (AESIs) including opportunistic infections and lymphoproliferative disease, and other immediately reportable events (IREs), in subjects with recent-onset T1DM who complete CP-MGA031-01. The secondary objectives of the extension study are to: 1) assess long-term efficacy; 2) evaluate immunological effects(North America only); 3) measure anti-teplizumab antibody levels;4) assess Health Related Quality of Life Questionnaires.
Groups/Cohorts in the Protégé study (CP-MGA031-01)
Protege had 4 study arms, 3 were dosed with different doses of teplizumab, and 1 was a control group given placebo. This Extension study will assess the subjects from these 4 arms.
1 Active
In Protege: Experimental Drug: Teplizumab, IV dosing daily for 14 days times 2 courses
2 Active
In Protege: Experimental Drug: Teplizumab, IV dosing daily for 14 days times 2 courses
3 Active
In Protege: Experimental Drug: Teplizumab, IV dosing daily for 14 days times 2 courses
1 controlled
In Protege: Placebo Comparator: IV dosing daily for 14 days times 2 courses
This is an Extension study. The patients from Core Study will be rolled over in this study for safety follow - up. No new patients would be recruited in this trial. Hence, status In this trial Globally 538 patients will be included. From India 150 subjects are to be included. Globally, the trail has started on 14-Feb-09. In India, the first patient would be enrolled on 25-Sep-09.
Study Type: This is a non-interventional extension study.
Update as on 10-Feb-2011: The status of the trial is "Closed to recruitment and Follow-up." |