<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20171122037571N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-05</date_registration>
      <primary_sponsor>Arya Tina Gene company</primary_sponsor>
      <public_title>ِDetermining efficacy and safety of recombinant growth hormone Somatin® (AryaTinaGene) compared to Norditropin® (Novonordisk) in children with growth hormone deficiency</public_title>
      <acronym></acronym>
      <scientific_title>ِDetermining efficacy and safety of recombinant growth hormone Somatin® (AryaTinaGene) compared to Norditropin® (Novonordisk) in children with growth hormone deficiency: A non-inferiority phase III randomized parallel clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37419</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random Chain Generation performed using by (https://www.sealedenvelope.com)We used randomized permutations, blocks (the size of each block is 4) for a total of 80 volunteers (1: 1 ratio). The codes will be labeled on the drugs. After ensuring the volunteer's eligibility and signing the informed consent form, a nurse will receive a code from the study site which will be used for random allocation of the drug to the candidate. The related drug will be used for the volunteer. In this way, the volunteers fall into one of the two intervention groups and the volunteers' group and the type of drug they receive will not be disclosed to researchers or the study team, Blinding description: In this clinical trial, blindness can not be fully accomplished (due to the brand's exclusive form of this drug, this is not possible for any study), but we try to minimize the information sources for different individuals in the study to prevent the Information bias. For this purpose, syringes containing both drugs are packaged with code only. Researchers who prescribe medication, those who provide the drug to patients, and those who are responsible for the examination and evaluation of patients, will be unaware of the nature of the syringes, and during this study.</study_design>
      <phase>3</phase>
      <hc_freetext>Short stature due to endocrine disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: AryaTinaGen recombinant Growth Hormone, 35µg/kg/d, subcutaneous injection. Intervention 2: Control group: Norditropin recombinant Growth Hormone 35 µg/kg/d, subcutaneous injection.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ayat Ahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>23rd unit, 4th floor, No 1547, North Kargar Street,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417993337</zip>
        <telephone>+98 21 8896 3546</telephone>
        <email>ayat1049@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Zarei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Taleghani children hospital, Janbazan Blvd, Gorgan</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4979146595</zip>
        <telephone>+98 17 3222 7720</telephone>
        <email>dr.zaeri@yahoo.com</email>
        <affiliation>Gorgan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children older than 2  and younger than 10 for girls and 11 for boys.
Short stature with height standard deviation score (HSDS) &lt; −3SD,
No increase in growth hormone more than 10 or 20 mlU/L after fasting and clonidine stimulating test
Signing the written informed consent by the gradians and assent by children older than 7</inclusion_criteria>
      <agemin>2 years</agemin>
      <agemax>11 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any history of using GH or history of using estrogen of adrenal androgens within last year.
History of seizure, sleep apnea syndrome or other respiratory disorders.
Concomitant use of corticosteroid
Any chronic systemic disorders  such as hypothyroidism, DM, rickets, skeletal dysplasia, pervious chromosomal abnormalities
Sensitivity to GH
History of chemotherapy of radiotherapy
Children with psychosocial dwarfism or idiopathic or familial short stature
Children with idiopathic or familial short stature
Spinal disorders such as scoliosis, kyphosis, chiari malformation, spinabifida variations</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E34.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Short stature due to endocrine disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: AryaTinaGen recombinant Growth Hormone, 35µg/kg/d, subcutaneous injection</i_keyword>
      <i_keyword>Control group: Norditropin recombinant Growth Hormone 35 µg/kg/d, subcutaneous injection</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body height. Timepoint: Before treatment and 3, 6, 9 and 12 months later. Method of measurement: Using harpenden wall mounted stadiometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Insulin-Like Growth Factor 1 serum level. Timepoint: Before treatment and 6 and 12 months later. Method of measurement: Hematology lab test.</sec_outcome>
      <sec_outcome>Insulin-like growth factor-binding protein 3 serum level. Timepoint: Before treatment and 6 and 12 months later. Method of measurement: Hematology lab test.</sec_outcome>
      <sec_outcome>Bone age wrist. Timepoint: Before treatment and 12 months later. Method of measurement: Left wrist x-ray.</sec_outcome>
      <sec_outcome>Weight. Timepoint: Before treatment and 3,6,9 and 12 months later. Method of measurement: Scale.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Arya Tina Gene company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-30</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Room 105 , 5th floor, Central construction of Tehran University of Medical Sciences, Ghods intersection, Keshavarz blvd. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-13</approval_date>
        <contact_name>Golestan University of Medical sciences</contact_name>
        <contact_address>Hirkan Blvd, Gorgan Gorgan Golestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
