Hebervis administration in patients suffering from buccal mucositis caused by chemotherapy [unsealed

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:

Hebervis administration in patients suffering from buccal mucositis caused by chemotherapy [unsealed radioactive].

Secondary indentifying numbers:

IG/FCG/MC/0207

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Heber Biotec S.A. Ministry of Public Health, CUBA

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 the Quality of Drugs(CECMED)

Authorization date :

15/11/2007

Reference number:

2082/05-007-07B.

Principal investigator

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

First name:

Elvira

Last name:

Dorticos Balea

Medical Specialty :

Specialist II Degree in Hematology

Affiliation:

Institute of Hematology and Immunology

Postal address:

San Francisco y Perla, Altahabana

City:

Havana

País:

Cuba

Zip Code:

10800

Telephone:

+53-76443521

Email address:

email@not.entered

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, "Juan Manuel Marquez" Pediatric Hospital. Dra. Loreta Peón Bertot.

Research ethics committees:

Institute for Hematology and Immunology, March 2nd 2007

Pediatric Hospital Juan Manuel Marquez, August 2008.

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

16/02/2008

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:

Mucositis post chemotherapy [unsealed radioactive].

Health condition(s) code:

Stomatitis

Mouth Diseases

Stomatognathic Diseases

Intervention(s):

Epidermal growth factor administration in viscous solution (10µg/ml), using the topical route of administration (oral) three times a day, for a 20-day term.

Intervention code:

Epidermal Growth Factor

Administration, Oral

Intervention keyword:

Hebervis

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):

Severe conditions of lesions will be determined daily, by the qualitative evaluation of patients through the clinical examination of the mucosa area, considering the phases in accordance with WHO: Grade 0: None. (There is no clinical symptomatology). Grade 1: Erythema. (There is only flare of the mucosa area). Grade 2: Erythema, ulcers in the mucosa area. The patient can eat solid foods. Slight pain. Grade 3: Erythema, edema, ulcers in the mucosa area. The patient can consume only liquid diet. Acute pain. Grade 4: Enteral or parenteral support. Acute pain. The following are the response criteria to be considered: -Favorable response: Lesions heal in a 10-day or less term. -Partial response: Lesions heal in a 10-15-day term; otherwise, to go from a superior to an inferior grade, during the same time. (Grades according to WHO scale). -Unfavorable response: No heal after 15 days. Grades 1, 2 - 3, 4 even administering the product. (Grades according to WHO scale).

Key secondary outcomes:

-General condition of the patient will be evaluated daily, through the OAG scale: This is a scale that results in mucosa changes from the initial to the final phase of the disease OAG gives quantitative and qualitative standards in eight items (values 1-3); the sum gives a rough estimate about the evolution of the patient (general condition). The higher the value of the scale, the worsen the evolution of the patient and vice versa -The following are the local adverse reactions will be considered: pruritus, burning, pain, exanthema, vesicle, bump, eschar, bleeding and the sudden or marked appearance of edema.

Selection criterias

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

Gender:

Male/Female

Minimum age:

1 year

Maximum age:

18 years

Inclusion criteria:

1. Cuban patients (both sexes and any skin color), fulfilling the above-mentioned diagnosis criterion. 2. Patients 1-18 years of age. 3. Voluntariness of the patient and parents or guardians, through the signing of the informed consent.

Exclusion criteria:

1. Allergy or antecedent of intolerance to biotechnology derivative products or some formulation components. 2. Serious systemic disorders that make treatment administration and the evaluation difficult.

Type of population:

Children

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:

2

Target sample size:

30

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:

Tania

Last Name:

Gonzalez Lopez

Affiliation:

Center for Genetic Engineering and Biotechnology.(CIGB), in Havana.

Postal Address:

31st Ave. between 158 and 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)- 2087379 (53-7)- 2087465 (53-7)- 208 7421

Email :

tania.gonzalez@cigb.edu.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:

Tania

Last Name:

Gonzalez Lopez

Affiliation:

Center for Genetic Engineering and Biothecnology (CIGB), in Havana.

Postal Address:

31st Ave. between 158 and 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)- 2087379 (53-7)- 2087465 (53-7)- 208 7421

Email :

tania.gonzalez@cigb.edu.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:

RPCEC00000063

Date of Registration in Primary Registry:

2010-12-27

Record Verification Date:

2008-06-09 20:00

Link to the spanish version:

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Hebervis administration in patients suffering from buccal mucositis caused by chemotherapy [unsealed

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