| CTRI Number |
CTRI/2009/091/000468 [Registered on: 04/08/2009] |
| Last Modified On: |
01/03/2013 |
| Post Graduate Thesis |
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| Type of Trial |
|
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Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Study of NTx®-265: human chorionic gonadotropin (hCG) and epoetin alfa (EPO) in acute ischemic stroke patients |
|
Scientific Title of Study
|
A Phase IIb prospective, randomized, double-blind, placebo controlled, dose escalation study of NTx®-265: human chorionic gonadotropin (hCG) and epoetin alfa (EPO) in acute ischemic stroke patients (REGENESIS-LED) |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT00938314 |
ClinicalTrials.gov |
| NTx®-265-CP-202-IS-IN |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
Not Applicable
N/A
India |
| Phone |
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| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr. Sudhir Kumar |
| Designation |
|
| Affiliation |
|
| Address |
8-2-269/3/1, Road No. 2
Banjara Hills
Hyderabad
ANDHRA PRADESH
500033
India |
| Phone |
+91-40-23607777 |
| Fax |
+91-40-23431726 |
| Email |
sudhir@mayaclinicals.com |
|
Details of Contact Person
Public Query
|
| Name |
Arulprakash. R |
| Designation |
|
| Affiliation |
|
| Address |
Sristek, Plot No.33, Sai Enclave
Road No. 12, Banjara Hills
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
+91-40-66743124 |
| Fax |
+91-40-66683777 |
| Email |
arul@sristek.com |
|
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Source of Monetary or Material Support
|
| Stem Cell Therapeutics Corp. Suite 1000, 1520-4th St. SW Calgary, Alberta, Canada T2R 1H5 |
|
Primary Sponsor
Modification(s)
|
| Name |
Stem Cell Therapeutics Corp |
| Address |
Suite 1000
1520 4th St SW
Calgary Alberta
Canada
T2R 1H5 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
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India |
|
Sites of Study
|
| No of Sites = 19 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. P. N. Sylaja |
Ananthapuri Hospitals & Research Institute |
,-695024
|
+91-471-2506565
+91-471 2506969
sylajapn@hotmail.com |
| Dr. Subhashini Prabhakar |
Apollo Hospitals |
Jubilee Hills,-500033
Hyderabad
ANDHRA PRADESH |
+91-40-23607777
+91-40-23431726
subhasiniprabhakar@yahoo.co.in |
| Dr. Jayanta Roy |
Appolo Gleneagles Hospitals |
58 ,Canal Circular Road-700054
Kolkata
WEST BENGAL |
+91-33-23302003
+91-33-23205218
roy_jayanta@yahoo.com |
| Dr. JMK Murthy |
Care Hospital |
Nampally,-500001
Hyderabad
ANDHRA PRADESH |
+91-40-30417777
+91-40-66835559
jmkmurthy@satyam.net.in |
| Dr. Jeyaraj Pandian |
Christian Medical College & Hospital |
,-141008
Ludhiana
PUNJAB |
+91-161-2229010
+91-161-2220850
jeyarajpandian@yahoo.co.in |
| Dr. Mathew Alexander |
Christian Medical College Hospital |
Department of Neurology,-632004
Vellore
TAMIL NADU |
+91-461-2232018
+91-461-2232035
mathewalex@cmcvellore.ac.in |
| Dr. Anthati Soma Keerthi |
DBR & SK Super Speciality Hospital |
No.18-1-505,Mosque Road-517501
|
+91-877-2222205
+91-877-2222489
somakeerthi2007@rediffmail.com |
| Dr.B.S.Keshava |
JSS Medical College Hospital |
Ramanuja Road,-570004
Mysore
KARNATAKA |
+91-821-2439949
+91-821-4253628
keshavabelur@gmail.com |
| Dr. E. Srikantha Reddy |
Kamineni Hospital |
L.B Nagar ,-500 0068
Hyderabad
ANDHRA PRADESH |
+91-40-39879999
+91-40-24020358
sreekanthemani@yahoo.co.in |
| Dr. Chandra Sekhar Reddy |
Krishna Institute of Medical Sciences |
1-8-31/1 Minister Road,-500003
Hyderabad
ANDHRA PRADESH |
+91-40-27725461
+91-40-27846666
neuroreddy@gmail.com |
| Dr. Vijaya Pamidimukkala |
Lalita Super Specialties Hospitals Pvt. Ltd |
Kothapet,-522001
Guntur
ANDHRA PRADESH |
+91-863-2222866
+91-863-2328160
vijayapvr@yahoo.com |
| Dr. Chalasani Pramod |
Latha Superspecialities Hospital |
29-14-58,Prakasham Road,Suryaraopeta -520002
|
+91-866-2498483
+91-866-2498482
klmmhospital_vja@yahoo.co.in |
| Dr. R.Srinivasa |
M S Ramaiah Memorial Hospital |
New BEL Road,-560054
Bangalore
KARNATAKA |
+91-80-22183125
+91-80-40528402
drrsrinivasa@hotmail.com |
| Dr. Puneet Agarwal |
Max Super Speciality Hospital |
1-Press Enclave Road,Saket-110017
New Delhi
DELHI |
+91-11-66115050
+91-11-66116677
pgpuneet@gmail.com |
| Dr. K. Bhaskar Rao |
Mediciti Hospital |
5-9-22 ,Secretariat road -500063
Hyderabad
ANDHRA PRADESH |
+91-40-23231111
+91-40-23299078
bhaskarksreya@yahoo.com |
| Dr. Umesh Tukaram |
Owaisi hospital and research centre |
Department of neurology,kanchanbagh -500059
Hyderabad
ANDHRA PRADESH |
+91-40-24343723
+91-40-24345285
drumesh40@hotmail.com |
| Dr.Vikram Sharma |
St Theresa`s General Hospital |
Erragadda,Sanathnagar-500018
Hyderabad
ANDHRA PRADESH |
+91-40- 23701013
+91-40- 23710160
drvikramsharma@gmail.com |
| Dr .V.V.V B. Choudary |
Suraksha Neuro centre |
# 29-10-32,Narasimharaorrao Naidu Street,Suryaraopet-520002
|
+91-866- 2444545
+91-866-2444995
venkatvallabh@yahoo.co.uk |
| Dr. Suresh Kumar |
Vijaya Health Center |
175, NSK Salai,-600026
Chennai
TAMIL NADU |
+91-44 - 24800775
+91-44 - 23721302
doc_suresh@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 18 |
| Name of Committee |
Approval Status |
| Cerebral Independent Review Board for DBR & SK Super Specialty Hospital |
Approved |
| Cerebral Independent Review Board for Latha Superspecialties Hospital |
Approved |
| Cerebral Independent Review Board for Suraksha Neuro centre |
Approved |
| Christian Medical College |
Approved |
| Christian Medical College & Hospital, Ludhiana |
Approved |
| Ethics Committee, Apollo Hospitals |
Approved |
| Ethics Committee, Lalitha Super Specialities Hospital |
Approved |
| Ethics Committee,Mediciti Hospitals |
Approved |
| Institutional Ethical Committee, CARE Foundation |
Approved |
| Institutional Ethics committee of Ananthapuri Hospitals & Research Institute |
Approved |
| Institutional Ethics committee of Kamineni Hospitals |
Approved |
| Institutional Ethics Committee, Krishna Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee,Apollo Gleneagles Hospitals |
Submittted/Under Review |
| JSS Medical College Hospital |
Approved |
| M S Ramaiah Memorial Hospital |
Approved |
| Max Super Speciality Hospital |
Approved |
| St. Theresa`s General Hospital |
Approved |
| Vijaya Health Center |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Acute ischemic stroke, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Product Name: NTx-265: Human Chorionic Gonadotropin and Erythropoietin |
NTx®-265 treatment will be administered over 9 days: Human Chorionic Gonadotropin 385 µg/10,000 IU SC on Days 1, 3, and 5, then daily IV doses of epoetin alfa on Days 7, 8, and 9
In cohort 1 the daily IV dose of EPO will be 4,000 IU
In cohort 2 the daily IV dose of EPO will be 12,000 IU
In cohort 3 the daily IV dose of EPO will be 20,000 IU
|
| Comparator Agent |
Saline placebo |
Saline SC, on Day 1, 3, and 5, then Saline IV, on Day 7, 8, and 9 |
|
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
1. Age 18-85.
2. NIHSS score 8-20 within 24-48 hours after stroke onset and enrolment.
3. Stroke is ischemic in origin, supratentorial, and radiologically confirmed (CT scan or diagnostic MRI) prior to enrolment.
4. Patient is 24-48 hours from time of stroke onset when the first dose of NTx®-265 therapy is administered. Time of onset is when symptoms began; for stroke that occurred during sleep, time of onset is when patient was last seen or was self-reported to be normal.
5. Reasonable expectation of availability to receive the full 9 day NTx®-265 course of therapy, and to be available for subsequent follow-up visits.
6. Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated.
7. Female patient is either :
a. not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or,
b. if of childbearing potential, agrees to use two of the following effective separate forms of contraception throughout the study, up to and including the follow up visits:
? condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)contraceptives (e.g. implants, injectables, combined oral, etc.)
OR
? a vasectomized partner
OR
? abstinence
|
|
| ExclusionCriteria |
| Details |
1. Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
2. Patients who have received thrombolytic treatment with tPA following the index stroke
3. Patients classified as comatose, defined as a patient who requires repeated stimulation to attend, or is obtunded and requires strong or painful stimulation to make movements (NIHSS 1A score must be <2)
4. Women who have tested positive for pregnancy or are breast feeding or are not using a highly effective method of birth control that can be maintained for the duration of the study
5. Serum hemoglobin > 16 g/dL (males) or > 14 g/dL (females); or platelet count > 400,000/mm3
6. Advanced liver, kidney, cardiac or pulmonary disease; the former will be operationally defined using NCI Toxicity Criteria (Grade 2 or higher): Appendix I
7. Serum bilirubin > 1.5 x ULN
8. Alkaline phosphatase > 2.5 x ULN
9. AST or ALT > 2.5 x ULN
10. Creatinine > 2.0 x ULN
11. Patients with known and documented elevated PSA levels
12. Patients with a known history of hypercoagulability, including known cardiolipin / antiphospholipid antibody syndrome
13. Expected survival < 1 year
14. Allergy or other contraindication to hCG including:
a. Prior hypersensitivity to hCG preparations or one of their excipients
b. Primary ovarian failure
c. Uncontrolled thyroid or adrenal dysfunction
d. An uncontrolled organic intracranial lesion such as a pituitary tumor
e. Abnormal uterine bleeding of undetermined origin
f. Ovarian cyst or ovarian enlargement of undetermined origin
g. Sex hormone-dependent tumors of the reproductive organs, accessory sex glands, and breasts
15. Allergy or other contraindication to epoetin alfa:
a. Who developed pure red cell aplasia following treatment with any erythropoiesis regulating hormones
b. With uncontrolled hypertension
c. With known hypersensitivity to mammalian cell-derived products, albumin (human) or any component of the product
d. Who for any reason cannot receive adequate antithrombotic treatment
16. A known diagnosis of cancer in the previous 5 years (except non-malignant skin cancer)
17. Uncontrolled hypertension, defined in the context of acute stroke as blood pressure persistently above 220 mm Hg systolic or 120 mm Hg diastolic despite antihypertensive therapy
18. Use of either hCG or epoetin alfa within the previous 90 days
19. Any condition known to elevate hCG, active in the prior 24 months, e.g., choriocarcinoma or germ cell tumor
20. Patients with a pre-stroke/pre-morbid modified Rankin Score (mRS) ≥ 2
21. Any patients living in a nursing home or supervised living center. Patients must be historically fully independent in all activities of daily living including banking, shopping, cooking, toileting, showering and dressing.
22. Any other medical condition or degree of stroke such that, in the investigator?s opinion, the patient should not be included in the trial
23. With the exception of the qualifying stroke, any other stroke within the previous 3 months. Patients with asymptomatic stroke can be included if they meet the criteria described in Section 7.4.1.
24. Patients who cannot take anti-platelet or anti-coagulant therapy
25. Pre-existing and active major psychiatric or other chronic neurological disease
26. Consume, on average, greater than 14 alcoholic drinks per week, or have a history of substance abuse or dependency within 12 months prior to the study
27. Currently participating in another investigational study
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Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified Rankin Score (mRS)
NIHSS response |
Day 90 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| NIHSS,
mRS,
Barthel Index,
Action Research Arm Test,
Gait Velocity Test,
Boston Naming Test,
Line cancellation test,
Trails A & B test,
Geriatric Depression Scale
|
Day 90 |
|
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Target Sample Size
|
Total Sample Size="0"
Sample Size from India=""
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/08/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years=""
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
|
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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
|
The proposed study is a phase IIb, multi-center, randomized, double-blind placebo controlled study. It is being conducted at multiple sites in Canada, USA and India. The total sample size is 128 patients. In India, the study is proposed to be conducted at fifteen (15) investigative sites to recruit approximately 90 patients. The anticipated date of enrollment in India is 07 August 2009. The purpose of this study is to determine the safety and efficacy of the NTx®-265 (Human Chorionic Gonadotropin and Epoetin alfa) therapy in acute ischemic stroke patients over placebo. |