| CTRI Number |
CTRI/2010/091/000016 [Registered on: 13/01/2010] |
| Last Modified On: |
07/01/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
|
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Type of Study
|
|
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A study to evaluate the efficacy and safety of GAMMAPLEX in patients with chronic Idiopathic Thrombocytopenic Purpura |
Scientific Title of Study
Modification(s)
|
A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 125329 |
Other |
| GMX02 |
Protocol Number |
| NCT00504075 |
ClinicalTrials.gov |
| U1111-1112-7212 |
UTN |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Sunil Garg |
| Designation |
|
| Affiliation |
INC GVKBIO Pvt Ltd |
| Address |
INC GVKBIO Pvt Ltd
510-511, JMD Pacific Square, Sector 15 Part II
Gurgaon
HARYANA
122001
India |
| Phone |
0124-4642469 |
| Fax |
0124-4642401 |
| Email |
sgarg@incresearch.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Sunil Garg |
| Designation |
Sr. Manager Clinial Operations |
| Affiliation |
INC GVKBIO |
| Address |
INC GVKBIO Pvt Ltd
14th Floor, Tower B, Building No 14
DLF Cyber City, Phase III
Gurgaon
Gurgaon
HARYANA
122002
India |
| Phone |
911244642469 |
| Fax |
911244642401 |
| Email |
sgarg@incresearch.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Sunil Garg |
| Designation |
Sr Manager Clinical Operations |
| Affiliation |
INC GVKBIO Pvt. Ltd. |
| Address |
INC GVKBIO Pvt Ltd
14th Floor, Tower B, Building No 14
DLF Cyber City, Phase III
Gurgaon
HARYANA
122001
India |
| Phone |
911244642469 |
| Fax |
911244642401 |
| Email |
sgarg@incresearch.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Bio Products Laboratory |
| Address |
|
| Type of Sponsor |
|
|
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Details of Secondary Sponsor
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|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ajeet Nanda |
Site No. 202 |
,-
New Delhi
DELHI |
(0)9910104842
|
| Dr Nithin S |
Site No. 203 |
,-
Bangalore
KARNATAKA |
(0)9900412690
drnithins@hotmail.com |
| Meera Lobo |
Site No. 205 |
,-
Bangalore
KARNATAKA |
(0)9880200593
meera.lobo@ecronacunova.com |
| Venkat |
Site No. 206 |
,-
Hyderabad
ANDHRA PRADESH |
(0)9492120299
cpvr01@aherf-smo.org |
| Dr Nagesh |
Site No. 207 |
,-
Bangalore
KARNATAKA |
(0)9900182260
nagesh.gm@metropolisindoa.com |
| Dr Hiren Shah |
Site No. 209 |
,-
Ahmadabad
GUJARAT |
(0)9825407551
hirenshah27@gmail.com |
| Shweta Shende |
Site No. 211 |
,-
Pune
MAHARASHTRA |
9890365605
shwetashende@gmail.com |
| Madhuri Mahajan |
Site No. 212 |
,-
Hyderabad
ANDHRA PRADESH |
9391325566
madhurisamirmahajan@yahoo.com |
| Chirag Patel |
Site No. 216 |
,-
|
9909291163
chiragp@charutarhealth@org |
| Jay Patel |
Site No. 217 |
,-
Ahmadabad
GUJARAT |
9898498320
jay.clinicalresearch@yahoo.com |
| M V Subba Rao |
Site No. 218 |
,-Vijayawada
|
9652334413
subbarao.mannam5@gmail.com |
| Ajil Pon Singh |
Site No. 219 |
,-
Bangalore
KARNATAKA |
9900827946
ajilpon@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Bangalore Central Ethics Committee |
Approved |
| Ethics Committee Apollo Hospitals |
Approved |
| Ethics Committee of the Heart Care Clinic |
Approved |
| Ethics Committee Sir Ganga Ram Hospital |
Approved |
| Ethics Committee, Mahavir Hospital and Research Centre |
Approved |
| Human Research Ethics Committee |
Submittted/Under Review |
| Institutional Ethical Review Board |
Submittted/Under Review |
| Institutional Ethics Committee KMC Hospital |
Approved |
| Institutional Ethics Committee of Deenanath Mangeshkar Hospital and Research Centre |
Approved |
| M S Ramaiah MEdical College and Teaching Hospital Ethical Review Board |
Approved |
| Mallikatta Ethical Committee |
Approved |
| The Siddhant Independent Ethics Committee |
Submittted/Under Review |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Idiopathic Thrombocytopenic Purpura, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GAMMAPLEX (unmodified IgG) |
Total dose of 2g/kg body weight by intravenous infusion over a period of two consecutive days (1g/kg body weight per day) |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1) Males and females aged between 18 and 70 years. 2) Confirmed diagnosis of chronic ITP of at least 6 months
duration. 3) Platelet count ≤20 x 109/L at enrollment. 4) Absence of other conditions that, in the opinion of the
investigator, could cause thrombocytopenia. 5) If subjects are currently being treated with corticosteroids the
treatment regimen/dose must have been stable (for a minimum of 2 weeks before Day 1 infusion). However,
subjects must remain on a stable treatment regimen. If there is any intent to alter the corticosteroid treatment
regimen (e.g., tapering of corticosteroids) before Day 10, subjects may not be included in the study. 6) If
subjects are currently being treated with cyclophosphamide, azathioprine or attenuated androgens, the treatment
regimen and dose must have been stable for a minimum of 2 months before infusion on Day 1. However, if there
is any intent to alter the treatment regimen before Day 10, subjects may not be included in the study. 7)
Splenectomized subjects and both Rh(D)+ and Rh(D)- subjects may be included. 8) The subject has signed an
informed consent form (subjects must be at least 18 years old), and/or the subject?s legal guardian has signed the
informed consent form if indicated. 9) If a subject is a female of child-bearing potential, she must have a negative
result on a urine-based HCG pregnancy test. 10) If a subject is a female who is or becomes sexually active, she
must practice contraception by using a method of proven reliability for the duration of the study. |
|
| ExclusionCriteria |
| Details |
1) The subject has a history of any severe or anaphylactic reaction to blood or any bloodderived
product, or any severe reaction to IGIV or any other IgG preparation. 2) The subject is known to be
intolerant to any component of the investigational product. 3) The subject has received any live virus vaccine
within the last 3 months prior to Day 1. 4) The subject has received an IGIV preparation within 1 month prior to
Day 1. 5) The subject is currently receiving, or has received, any investigational agent within the 1 month prior to
Day 1. 6) The subject has received any blood, blood product, or blood derivative within the 1 month prior to Day
1. 7) The subject has received Rituximab within the 3 months before Day 1. 8) The subject is pregnant or is
nursing. 9) The subject is positive for any of the following at screening: HBsAg, NAT for HCV, NAT for HIV,Antibodies to HCV or HIV 1 or 2. 10) The subject, at screening, has levels greater than 2.5 times the upper limit of
normal, as defined by the central laboratory, of alanine aminotransferase or aspartate aminotransferase. 11) The
subject has a severe renal impairment (defined as serum creatinine greater than 2 times the upper limit of normal
or BUN greater than 2.5 times the upper limit of normal for the range of the laboratory doing the analysis); the
subject is on dialysis; the subject has a history of acute renal failure. 12) The subject is known to have abused
alcohol, opiates, psychotropic agents, or other chemicals or drugs within the past 12 months. 13) The subject has a
history of deep vein thrombosis (DVT) or thrombotic complications of IGIV therapy. 14 The subject has any
history or sign of hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolic event, or unstable
angina. 15) The subject suffers from any acute or chronic medical conditions (e.g., renal disease or predisposing
conditions for renal disease, coronary artery disease, or protein losing enteropathy) that, in the opinion of the
investigator, may interfere with the conduct of the study. 16) The subject has an acquired medical condition, such
as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (defined as an
absolute neutrophil count (ANC) < 1 x 109/L). 17) The subject has non-controlled arterial hypertension (systolic
blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg). 18) The subject is anemic (hemoglobin
<10 g/dL) at screening. 19) The subject is unlikely to adhere to the protocol requirements of the study or is likely
to be uncooperative. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy: To determine if GAMMAPLEX raises the platelet count of subjects
with chronic ITP to a threshold of 50 x 10_9/L, similar to that of a historical control. |
The primary efficacy variable will be analyzed using the intent?to-treat population ITT). The percent of subjects attaining a platelet count of ≥50 x 10_9/L by Day 9 will be compared with the historical response rate of >60%. A 1-sided 95% confidence interval will be constructed for the percent of subjects attaining a platelet count of ≥50 x 10_9/L by Day 9 for GAMMAPLEX. If the lower bound of this confidence interval is >0.60, GAMMAPLEX will be considered effective for the treatment of chronic ITP. Therfore, the primary efficacy variable will be the percent of subjects attaining a platelet count of ≥50 x 10_9/L by Day 9 (the 7th day after completing the second infusion). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objectives are:
1) to determine the safety of GAMMAPLEX at the dosage used in this study. 2) to determine if GAMMAPLEX
maintains platelet counts of ≥ 50 x 10_9/L in subjects with chronic ITP for a period of time similar to that of a historical control. |
The variables used to assess safety will be the following: adverse events; vital signs; clinical laboratory
tests and Direct Coombs? Test; any transmission of viruses; physical examination.
The two secondary efficacy variables: Duration of time for which the platelet counts remain ≥50 x 10_9/L after the first course of GAMMAPLEX and changes in the signs of any bleeding/hemorrhage up to Day 32.
The secondary efficacy variables will be analyzed by: 1) using the method of Kaplan and Meier to produce plots of
the distribution of the time for which the platelet counts remain ≥50 x 10_9/L; 2) a 95% confidence interval for the median time will be constructed. |
|
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Target Sample Size
|
Total Sample Size="31"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
03/03/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
18/01/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This clinical trial is a phase III, multicenter, open-label study to evaluate the efficacy and safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura, wherein the subjects will receive infusions of GAMMAPLEX on Days 1 and 2 (first treatment course). If the platelet count is not maintained for the desired length of time after the first course of GAMMAPLEX, and at the discretion of the study investigator and subject, subjects may receive up to a further 2 courses of
GAMMAPLEX within the period Day 32 to Day 90 of the first treatment course.
This study is being conducted in approximately 12 centres in India, 5 centres in USA and 9 centres in Argentina, with approximately 31 subjects to be competetively enrolled globally throughout the centres.
The primary objective of the study is to determine the efficacy by determining if GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 10_9/L, similar to that of a historical control. The secondary objectives of the study are: 1) to determine the safety of GAMMAPLEX at the dosage used in this study 2) to determine if GAMMAPLEX
maintains platelet counts of ≥ 50 x 10_9/L in subjects with chronic ITP for a period of time similar to that of a historical control. |