| CTRI Number |
CTRI/2008/091/000262 [Registered on: 27/11/2008] |
| Last Modified On: |
01/03/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Biological
Stem Cell Therapy |
| 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 study of NTxTM-265: human chorionic gonadotropin (hCG) and epoetin alfa (EPO) in acute ischemic stroke patients (REGENESIS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT00663416 |
ClinicalTrials.gov |
|
|
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
|
| 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 |
Mr. Arulprakash |
| 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 |
|
|
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 |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.Jayanta Roy |
AMRI Hospital |
P4 & 5, CIT Scheme,Ghariahat Road South-700029
Kolkata
WEST BENGAL |
+91-33-24612526
+91-33-24400455
roy_jayanta@yahoo.com |
| Dr. Subhashini Prabhakar |
Apollo Hospitals |
Jubilee Hills,-500033
Hyderabad
ANDHRA PRADESH |
+91-40-23607777
+91-40-23431726
subhasiniprabhakar@yahoo.co.in |
| Dr.Subhash C Mukherjee |
B.P.Poddar Hospital & Medical Research Ltd |
71/1, Humayun Kabir Sarani,Block G-700053
Kolkata
WEST BENGAL |
+91-33-24554079
+91-33-24577009
subhash_mukherjee@vsnl.net |
| Dr. J.M.K. 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. Chandra Sekhar Reddy |
Krishna Institute of Medical Sciences |
1-8-31/1 Minister Road,-500 003
Hyderabad
ANDHRA PRADESH |
+91-40-27725461
+91-40-27846666
neuroreddy@gmail.com |
| 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. Subash Kaul |
Nizam Institute of Medical Sciences |
Punjagutta,-500082
Hyderabad
ANDHRA PRADESH |
+91-40-30602165
+91-40-30602165
subashkaul@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| AMRI Hospital |
Submittted/Under Review |
| Apollo Hospitals |
Approved |
| B.P.Poddar Hospital & Medical Research Ltd |
Submittted/Under Review |
| Care Hospital |
Submittted/Under Review |
| Christian Medical College |
Approved |
| Christian Medical College & Hospital, Ludhiana |
Submittted/Under Review |
| Krishna Institute of Medical Sciences |
Approved |
| M S Ramaiah Memorial Hospital |
Submittted/Under Review |
| Max Super Speciality Hospital |
Submittted/Under Review |
| Nizam Institute of Medical Sciences |
Submittted/Under Review |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Acute ischemic stroke , |
|
|
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 10,000 IU SC on Days 1, 3, and 5, then epoetin alfa 30,000 IU IV on Days 7, 8, and 9. |
| Comparator Agent |
Saline placebo |
Saline SC, on Day 1, 3, and 5, then Saline IV, on Day 7, 8, and 9 |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-85.
2. NIHSS score 6-24 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. MRI is mandatory for patients included in the MRI sub-study.
4. Patient is 24-48 hours from time of stroke onset when the first dose of NTxTM-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 NTxTM-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, contraceptives (e.g., implants, injectables, combined oral, etc)
OR
? A vasectomised partner
OR
? Abstinence
|
|
| ExclusionCriteria |
| Details |
1. Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
2. Patients classified as comatose, defined as a patient who required repeated stimulation to attend, or is obtunded and requires strong or painful stimulation to make movements (NIHSS 1A score must be <2).
3. 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.
4. Serum hemoglobin > 16 g/dL (males) or > 14 g/dL (females). Platelet count > 400,000/mm3.
5. Advanced liver, kidney, cardiac and/or pulmonary disease; the former will be operationally defined using NCI Toxicity Criteria (Grade 2 or higher): Appendix II
6. Serum bilirubin > 1.5 x upper limit of normal (ULN)
7. Alkaline phosphatase > 2.5 x ULN
8. AST > 2.5 x ULN, ALT > 2.5 x ULN
9. Creatinine > 2.0 x ULN
10. Patients with known and documented transferrin saturation < 20%. Patients with known and documented Ferritin < 100 ng/mL.
11. Patients with known and documented elevated PSA levels, or a PSA level of ≥ 4 ng/mL at screening.
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 (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 6 months.
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 |
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Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified Rankin Score (mRS)
NIHSS response |
Day 90 |
|
|
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 |
Day 90 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="0"
Sample Size from India="90"
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) |
15/12/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Other (Terminated) |
| 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. In India, the study is proposed to be conducted at ten (10) investigative sites to recruit approximately 60 patients. 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. |