Combifer vs Trofin phase II in anemic pregnant women.

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:

Protocol Phase II Clinical Trial Combifer vs Trofin in the treatment of anemic pregnant women.

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

National Center of Bioproducts (BioCen) Ministry of Public Health (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)

Reference number:

In process

Principal investigator

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

First name:

Norma

Last name:

Silva Leal

Medical Specialty :

Second grade Specialist in Gynaecology and Obstetrics

Affiliation:

Teaching Hospital Maternal Children 10 de Octubre

Postal address:

Regla # 52 between Nuestra Señora de la Caridad and Remedios. Lawton district. 10 de Octubre Municipality

City:

La Habana

Country:

Cuba

Zip Code:

10700

Telephone:

+53-76967168

Email address:

hijasgal@infomed.sld.cu [1]

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:

Not applicable

Research ethics committees:

Teaching Hospital Maternal Children 10 de Octubre, november 20, 2014

Recruitment status

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

Recruitment status:

Suspended

Date of first enrollment:

30/04/2015

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:

Anemia

Intervention(s):

Study Group I: Combifer 500 mg 3 tablets / day (orally) as follows: 1 tablet half hour before breakfast, another half hour before lunch and another half hour before eating; for a duration of at most up to 8 months. Control Group II: Trofin 235 mL 3 tbsp (15 mL) / day (orally) as follows: 1 tablespoon half hour before breakfast, another half hour before lunch and another half hour before eating; for a duration of at most up to 8 months.

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):

Hemoglobin (Hb). Measurement time: at baseline, and every 8 weeks until childbirth.

Key secondary outcomes:

- Hematocrit (%). Measurement time: at baseline, and every 8 weeks until childbirth. - Serum iron (mmol / L). Measurement time: at baseline, and every 8 weeks until childbirth. - Reticulocytes (%). Measurement time: at baseline, and every 8 weeks until childbirth. - Mean Corpuscular Volume (fl). Measurement time: at baseline, and every 8 weeks until childbirth. - Corpuscular Hemoglobin Media (pg). Measurement time: at baseline, and every 8 weeks until childbirth. - Mean Corpuscular Hemoglobin Concentration (g / L). Measurement time: at baseline, and every 8 weeks until childbirth. - Distribution of erythrocytes Rate (%). Measurement time: at baseline, and every 8 weeks until childbirth. - Middle Platelet Volume (fl). Measurement time: at baseline, and every 8 weeks until childbirth. - Platelet Distribution Rate (%). Measurement time: at baseline, and every 8 weeks until childbirth. - Ferritin (ng / mL). Measurement time: at baseline, and every 8 weeks until childbirth. - Transferrin receptor (mg / L). Measurement time: at baseline, and every 8 weeks until childbirth. - Adverse events (AE). Measurement time: at baseline, and every 8 weeks until childbirth. It will be measured by: Occurrence of some AE in the patient (yes/no). Description of the AE (Name of adverse event). According to available previous information (unexpected and expected). Intensity of the AE (Light, Moderate, Severe). Graveness of the AE (Serious, No serious). Attitude regarding the treatment in study without changes, temporary or definitive interruption of the treatment in study). Result of the AE (Recovered, Improved, Persists or sequels) Causal Relationship of the AE (1.Very likely, 2.Likely, 3.Possible, 4.Unlikely, 5.Not related, 6.Not evaluated)

Selection criterias

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

Gender:

Female

Minimum age:

14 years

Maximum age:

45 years

Inclusion criteria:

1. Patients who have given their informed consent to participate in the trial. 2. Patients with pregnancy between 9 and 34 weeks. 3. Patients with hemoglobin levels between 70 and 109 g / L. 4. Patients who have not received transfusions two weeks before the study.

Exclusion criteria:

1. Patients who present acute gastrointestinal disorders that mask treatment (vomiting, diarrhea). 2. Patients who received transfusions in the two prior weeks to their inclusion in the study .

Type of population:

Children and Adults

Type of participant:

Patients

Study design

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

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

Target sample size:

390

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:

Norma

Last Name:

Silva Leal

Specialty:

Second grade Specialist in Gynaecology and Obstetrics

Affiliation:

Teaching Hospital Maternal Children 10 de Octubre

Postal Address:

Regla # 52 between Nuestra Señora de la Caridad and Remedios. Lawton district. 10 de Octubre Municipality

City:

La Habana

Country:

Cuba

Zip Code:

10700

Telephone:

+537-6967168

Email :

hijasgal@infomed.sld.cu [1]

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:

Elisa

Last Name:

Aznar García

Specialty:

PhD Health. Titular Researcher. Drug Registration Specialist and Clinical Trials.

Affiliation:

National Center of Bioproducts (BioCen)

Postal Address:

Road Beltran, 1and ½ km. Mayabeque Province.

City:

Bejucal

Country:

Cuba

Zip Code:

32600

Telephone:

+537682201 ; ext 1145

Email :

eaznar@biocen.cu [2]

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:

RPCEC00000192

Date of Registration in Primary Registry:

08/04/2015

Record Verification Date:

2019/11/26

Next update date:

2020/11/26

Link to the spanish version:

Click here [3]