Safety evaluation of Recombinant Human Erythropoietin ior EPOCIM in the treatment of patient with cerebral infarction acute. Study Stage I.

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Safety evaluation of Recombinant Human Erythropoietin ior EPOCIM in the treatment of patient with Cerebral Infarction Acute.Study Stage I.

Secondary indentifying numbers:

IIC RD-095

Issuing authority of the secondary identifying numbers:

Center of Molecular Inmunology(CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM) Ministry of Health publishes (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

12/01/2007

Reference number:

098/05.036.06.B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

MD. Jesus. Doctor of Science.

Last name:

Perez Nellar

Medical Specialty :

Second degree in Neurology.Titular Professor.

Affiliation:

Hermanos Ameijeiras Hospital

Postal address:

San Lázaro 701. Habana 3.

City:

La Habana

País:

Cuba

Zip Code:

10300

Telephone:

+53-78761000

Email address:

jesus.perez@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana City,National Institute of Neurology and Neurosurgery,MD.Alejandro Pando.Second degree in Neurology, Second degree in Intensive Medicine,Assistant Researcher

Havana City,Luis Diaz Soto Hospital,MD.Jaime Parellada Blanco.Second degree in Intensive Medicine and Emergency

Research ethics committees:

Hermanos Ameijeiras Hospital,November 20,2008

Luis Diaz Soto Hospital,January 07,2009

National Institute of Neurology and Neurosurgery, April 18,2006

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Suspended

Date of first enrollment:

06/01/2008

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Acute Cerebral Ischemic Stroke.

Intervention(s):

ior EPOCIM: 3.3 x 104 IU in the form of intravenous infusion and hydration with saline solution at 0.9% a rate of between 1500 and 2000 mL daily for three consecutive days and Acetylsalicylic acid (ASA), 250 mg daily, orally, from the patient's inclusion in the study and after graduation continued for life.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Adverse event type, event name,measurement time after the first infusion and up to 3 months. Duration of adverse events, measurement time: from the first infusion and up to 3 months. Severity of adverse events, serious or not, measurement time: from the first infusion and up to 3 months. Intensity of adverse events, mild, moderate, severe, measurement time: after the first infusion and up to 3 months. Attitude to the drug: change, change in dose or temporary interruption of the final treatment, measurement time: after the first infusion and up to 3 months. Result: Recovered, Improved, persists or left Aftermath, measurement time: after the first infusion and up to 3 months. Causal relationship, very likely, likely, possible, unlikely, not related or not assessable), measurement time: after the first infusion and up to 3 months. Treatment, measurement time: from the first infusion and up to 3 months. Blood pressure values, T/A in mm/Hg, every 4 hours during the first 3 days and every 8 hours until discharge. Body temperature in degree celcius every 4 hours during the first 3 days and every 8 hours until discharge. Hemoglobin (g/l), hematocrit (%), measurement time: at admission and daily until the 5th day.

Key secondary outcomes:

Neurological status of the patient, between 0 and 4 points, measurement time: 7 days, 3 months of treatment. Functional status of the patient assessments at intervals of 5 points between 0 and 15, measurement time: 7 days, 3 months of treatment.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

80 years

Inclusion criteria:

1.Consent for participation in the study of written patient or his legal representative. 2.Patients aged between 18 and 80 years. 3.Patients with a punctuation between 5 and 25 on the Ictus Scale of the Institute of Health Stroke of the United States.(National Institute of Health Stroke Scale-NIHSS). 4.Therapeutic window of less than or equal to 8 hours,from the time that symptoms appear,as calculated by the information provided by the patient or family.

Exclusion criteria:

1.Presence of hyperdense lesion of blood observed on the initial CT,either intraparenchymal hemorrhage or Cerebral Infarction with haemorrhagic transformation. 2.Isolated neurological defects such as:ataxia,loss of sensation,muscle weakness or dysarthria minimum. 3.Patients with neurological symptoms or signs return to normal before the start of treatment. 4.Suspected inflammatory vascular diseases as a cause of the current ICI,lupus and other diseases of collagen. 5.Head trauma or intracranial surgery recently,less than 4 weeks. 6.Known bleeding disorder. 7.Severe arterial hypertension and non-controlled, higher systolic 220 or diastolic 110 mm Hg higher, which does not fall after treatment. 8.Patients with higher hematocrit of 47% or leukocytosis above 12 x 106 at debut. 9.Patients which demonstrated coexistence of another disease process or lead to significant disability, cancer,septic emboli,endocarditis,malignant hypertension,myeloproliferative disease,higher creatinine 3mg/dl,hyperkalaemia increased 5.0mmol/l. 10.Patients with a history of hypersensitivity to EPO-hr. 11.Pregnant or breast-feeding.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Non-randomized controlled trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

1

Target sample size:

20

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

MD.Patricia

Last Name:

Piedra

Specialty:

2nd degree of Pharmacology

Affiliation:

CIMAB S.A

Postal Address:

206,No.1926.e/19 and 21,Atabey,Playa

City:

La Habana

País:

Cuba

Zip Code:

11600

Telephone:

537-271-5057.Ext.111

Email :

patrip@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Dra.Patricia

Last Name:

Piedra

Affiliation:

CIMAB S.A

Postal Address:

206.No.1926 e/19 and 21,Atabey ,Playa

City:

La Habana

País:

Cuba

Zip Code:

11600

Telephone:

537-271-5057.Ext.111

Email :

patrip@cim.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000078

Date of Registration in Primary Registry:

2009-07-03

Record Verification Date:

2009-06-24 20:00

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Safety evaluation of Recombinant Human Erythropoietin ior EPOCIM in the treatment of patient with cerebral infarction acute. Study Stage I.

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