<?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>IRCT2013020612380N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-05-07</date_registration>
      <primary_sponsor>Aryogen biopharma co.</primary_sponsor>
      <public_title>Comparing the cost-effectiveness of  two alternative bypassing agents  (aryoseven &amp; feiba )for haemophilia</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the cost-effectiveness of  two alternative bypassing agents (aryoseven &amp; feiba) for patients with  hemophilia A complicated by an inhibitor in Iran</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/12439</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Haemophilia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1:&#13;
patients  based on the belief treatment  &amp; based on previous history (questionnaire available) are divided into consumer Aryo (Group A), &#13;
 two bleeding event in each category will be discussed.(which is a very important factor in the effectiveness of treatment and could be confounding factors in most studies, it is not accurate) and medication requirements, and form of CRF (monitoring symptoms during 1,3,6,9,12 ) will be delivered. &#13;
 Protocol A &#13;
• Injection Dosage: The dose of 90-120 mg / kg body weight (mean 100 mg / kg body weight) • Injection time - 0 hours and 3 - 6 pm If pain assessment and limitations Moving clocks 3 and 6 are both negative dose of 270 mg / kg injection - at 9 or 12 for the assessment of pain and limitations of movement is negative, just one more dose of 270 mg / kg injections (up to 2 times per stroke, bleeding dosage 3 to be given). Intervention 2: Intervention group 2:&#13;
 Patient care based on the belief &amp; treatment history (according to the questionnaire) will be divided into consumer Faiba (Group F): 2 bleeding event in each category will be discussed   1,3,6,9,12 ) will be delivered. &#13;
Protocol F (Appendix Figure 2): &#13;
• First dose at zero time :50-75 units / kg body weight &#13;
• Second dose at 9 pm only if both pain and limitation of movement in 6 and 9pm are negative (no improvement in 6 hours Recent or severe pain 9) with 75 to 100 units / kg will repeat. • * If both protocols is less than 8 out of the 12 hours following drug treatment will change, but the calculation model, the drug has no further role. Intervention 3: Control group:&#13;
 because  of consistency of study the patients are divided into control group(O)   Indifferent or new.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mina Golestani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pharmacy faculty, Shahid Beheshti University of Medical Sciences,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 41 1336 6290</telephone>
        <email>mgolestani8958@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Peyman Eshghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Haemophilia Clinic of mofid Children hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 2290 4536</telephone>
        <email>peyman64@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: patients with severe hemophilia a with high inhibitor titers (greater than or equal to 5 Bethesda) in pilot studies to assess the attitude of coagulation shortcuts are classified.&#13;
 Exclusion criteria: patients who have previously unclassified; patients with coagulation problems, developed liver problems; patients who received coagulation products is over 5 days ago and  patients who have bleeding arthritis in the joint within 7 days ago.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>D66</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hereditary factor VIII deficiency</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1:&#13;
patients  based on the belief treatment  &amp; based on previous history (questionnaire available) are divided into consumer Aryo (Group A), &#13;
 two bleeding event in each category will be discussed.(which is a very important factor in the effectiveness of treatment and could be confounding factors in most studies, it is not accurate) and medication requirements, and form of CRF (monitoring symptoms during 1,3,6,9,12 ) will be delivered. &#13;
 Protocol A &#13;
• Injection Dosage: The dose of 90-120 mg / kg body weight (mean 100 mg / kg body weight) • Injection time - 0 hours and 3 - 6 pm If pain assessment and limitations Moving clocks 3 and 6 are both negative dose of 270 mg / kg injection - at 9 or 12 for the assessment of pain and limitations of movement is negative, just one more dose of 270 mg / kg injections (up to 2 times per stroke, bleeding dosage 3 to be given).</i_keyword>
      <i_keyword>Intervention group 2:&#13;
 Patient care based on the belief &amp; treatment history (according to the questionnaire) will be divided into consumer Faiba (Group F): 2 bleeding event in each category will be discussed   1,3,6,9,12 ) will be delivered. &#13;
Protocol F (Appendix Figure 2): &#13;
• First dose at zero time :50-75 units / kg body weight &#13;
• Second dose at 9 pm only if both pain and limitation of movement in 6 and 9pm are negative (no improvement in 6 hours Recent or severe pain 9) with 75 to 100 units / kg will repeat. • * If both protocols is less than 8 out of the 12 hours following drug treatment will change, but the calculation model, the drug has no further role</i_keyword>
      <i_keyword>Control group:&#13;
 because  of consistency of study the patients are divided into control group(O)   Indifferent or new</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 1, 3, 6, 9 and 12 hours after intervention. Method of measurement: Measure kavakli.</prim_outcome>
      <prim_outcome>Range of motion. Timepoint: 1, 3, 6, 9 and 12 hours after intervention. Method of measurement: Measure kavakli.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Bleeding control. Timepoint: 24 hours. Method of measurement: Evaluation of treatment success.</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>Aryogen biopharma co.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-02-03</approval_date>
        <contact_name>congenital blood disease research/Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Mofid Children's Hospital tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
