<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01689831</url>
  </required_header>
  <id_info>
    <org_study_id>JHP - 42023</org_study_id>
    <nct_id>NCT01689831</nct_id>
  </id_info>
  <brief_title>Dose Study of Tuberculin Purified Protein Derivative (JHP/Dose)</brief_title>
  <official_title>Dose Comparison Study of Tuberculin Purified Protein Derivative (PPD)With Standard Tuberculin Purified Protein Derivative.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JHP Pharmaceuticals LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Syneos Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>JHP Pharmaceuticals LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the&#xD;
      standard tuberculin purified derivative (PPD-S2).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      JHP proposes to demonstrate clinical comparability of Aplisol formulated from the new&#xD;
      Tuberculin PPD drug substance to the standard PPD-S2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">October 2012</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Confirm the potency of Aplisol equipotent to PPD-S2.</measure>
    <time_frame>72 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess tolerability of Aplisol with new tuberculin PPD</measure>
    <time_frame>72 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">168</enrollment>
  <condition>Tuberculosis Infection</condition>
  <arm_group>
    <arm_group_label>Aplisol, potency determination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference standard PPD-S2, reference</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Reactivity of Aplisol compared to reference standard PPD-S2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.</intervention_name>
    <description>Comparison of different dosages of Aplisol PPD relative to reference standard PPD-S2.</description>
    <arm_group_label>Aplisol, potency determination</arm_group_label>
    <arm_group_label>Reference standard PPD-S2, reference</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Reactivity of Aplisol compared to reference standard PPD-S2.</intervention_name>
    <description>Reference standard PPD-S2 formulated to contain different dose concentrations.</description>
    <arm_group_label>Aplisol, potency determination</arm_group_label>
    <arm_group_label>Reference standard PPD-S2, reference</arm_group_label>
    <other_name>Reference standard PPD-S2.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or nonpregnant females age 18 to 60 years&#xD;
&#xD;
          2. Documented PPD reactivity of 5 to 21 mm in the past, documented in a medical record.&#xD;
             Self-reported PPD reactivity will be accepted if medical records cannot be obtained.&#xD;
&#xD;
          3. Give written informed consent to participate&#xD;
&#xD;
          4. Generally healthy, as determined by medical history and targeted physical examination,&#xD;
             if indicated&#xD;
&#xD;
          5. Possess 2 forearms that are free of burns, scars, eczema, or any physical deformity,&#xD;
             which could impair injection of study preparation or the readings of the injections&#xD;
&#xD;
          6. Comprehension of the study requirements; expressed availability for the required study&#xD;
             period, including readings at the nominal time points of 48 and 72 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior PPD test within the past 30 days&#xD;
&#xD;
          2. Subject is of childbearing potential and unable to use contraceptives; is planning&#xD;
             pregnancy; is pregnant or lactating&#xD;
&#xD;
          3. History of anaphylactic reaction, severe positive tuberculin reaction (eg, ulceration,&#xD;
             necrosis) or other severe reaction to PPD in the past&#xD;
&#xD;
          4. Subject received a Bacillus Calmette-Guérin (BCG) vaccination in the past, or was born&#xD;
             or lived outside the US as a child and is uncertain of his/her BCG vaccination status&#xD;
&#xD;
          5. Presence of conditions that may suppress TST reactivity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Cyndy Hughes</last_name>
    <phone>919-876-9300</phone>
    <email>Cyndy.Hughes@INCResearch.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Tyler</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75708</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joe Santor, Pharm D.</last_name>
      <phone>903-877-7632</phone>
      <email>clin.res@uthct.edu</email>
    </contact>
    <investigator>
      <last_name>David Griffith, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>July 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>September 18, 2012</last_update_submitted>
  <last_update_submitted_qc>September 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tuberculosis</mesh_term>
    <mesh_term>Latent Tuberculosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01689831
org study id: JHP - 42023
nct id: NCT01689831
lead sponsor: 
collaborator: 
has dmc: No
Dose comparison study of tuberculin purified protein derivative (PPD)Aplisol with the
      standard tuberculin purified derivative (PPD-S2).
JHP proposes to demonstrate clinical comparability of Aplisol formulated from the new
      Tuberculin PPD drug substance to the standard PPD-S2.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Care Provider)
measure: Confirm the potency of Aplisol equipotent to PPD-S2.
time frame: 72 hours
measure: Assess tolerability of Aplisol with new tuberculin PPD
time frame: 72 hours
arm group label: Aplisol, potency determination
arm group type: Experimental
description: To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.
arm group label: Reference standard PPD-S2, reference
arm group type: Active Comparator
description: Reactivity of Aplisol compared to reference standard PPD-S2.
intervention type: Biological
intervention name: To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.
description: Comparison of different dosages of Aplisol PPD relative to reference standard PPD-S2.
arm group label: Aplisol, potency determination
arm group label: Reference standard PPD-S2, reference
intervention type: Biological
intervention name: Reactivity of Aplisol compared to reference standard PPD-S2.
description: Reference standard PPD-S2 formulated to contain different dose concentrations.
arm group label: Aplisol, potency determination
arm group label: Reference standard PPD-S2, reference
other name: Reference standard PPD-S2.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cyndy Hughes
phone: 919-876-9300
email: Cyndy.Hughes@INCResearch.com
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Tuberculosis
mesh term: Latent Tuberculosis