xml: <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/NCT05988463</url>
    </required_header>
    <id_info>
      <org_study_id>71488</org_study_id>
      <nct_id>NCT05988463</nct_id>
    </id_info>
    <brief_title>Open-Label Dose-Escalation Treatment Study of Patients With IPF</brief_title>
    <acronym>DIAMOND</acronym>
    <official_title>A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Patients With Idiopathic Pulmonary Fibrosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Joseph C. Wu</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Stanford University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive fibrotic lung disease resulting&#xD;
        in increasing shortness of breath, cough, and low oxygen levels as a result of lung tissue&#xD;
        scarring . The goal of this open-label (no placebo) study is to evaluate the safety and&#xD;
        tolerability of artesunate at three different doses in patients with IPF. The secondary goals&#xD;
        are to explore the blood biomarkers present in IPF patients at the beginning of the study and&#xD;
        to study how those biomarkers change following treatment with artesunate. Participants will&#xD;
        have 7 visits to the study site over 20 weeks which will include physician exams, vital&#xD;
        signs, questionnaires, research and safety blood samples, and taking artesunate capsules by&#xD;
        mouth for 12 weeks.&#xD;
  &#xD;
        Artesunate is used world-wide for the treatment of severe malaria but has also been found to&#xD;
        block specific proteins that cause lung scarring and may provide an additional treatment to&#xD;
        slow the fibrotic process in the lung and improve survival and quality of life for patients&#xD;
        with IPF.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Open label, dose escalation treatment study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants who experience treatment-related adverse events</measure>
      <time_frame>12 weeks</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Idiopathic Pulmonary Fibrosis</condition>
    <arm_group>
      <arm_group_label>Artesunate</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Artesunate Oral Product</intervention_name>
      <description>Artesunate capsules administered orally twice daily beginning at 10 mg for 4 weeks, followed by 20 mg for 4 weeks, and then 30 mg for 4 weeks.</description>
      <arm_group_label>Artesunate</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Participants, aged 40 years or older.&#xD;
  &#xD;
            2. Diagnosis of IPF based upon ATS/ERS/JRS/ALAT 2018 guidelines (55).&#xD;
  &#xD;
            3. FVC percent of predicted ≥ 40%; historical FVC for entry in the study is permitted if&#xD;
               within 3 months of screening.&#xD;
  &#xD;
            4. Diffusing capacity of lung for carbon monoxide (DLco) (hemoglobin-adjusted) ≥ 30%;&#xD;
               historical DLco for entry in the study is permitted if within 3 months of screening.&#xD;
  &#xD;
            5. Participants currently receiving treatment for IPF with nintedanib or pirfenidone are&#xD;
               allowed, provided these drugs have been given at a stable dose for at least 6 weeks&#xD;
               before the Screening visit (stable dose is defined as the highest dose tolerated by&#xD;
               the participant during ≥ 6 weeks).&#xD;
  &#xD;
            6. Female participants of childbearing potential (i.e., ovulating, premenopausal, and not&#xD;
               surgically sterile) and all male participants with sexual partners of childbearing&#xD;
               potential must use highly effective methods of birth control during their&#xD;
               participation in the study and for 60 days after the last administration of study&#xD;
               drug. Highly effective methods of birth control are defined as those with 99% or&#xD;
               greater efficacy.&#xD;
  &#xD;
            7. Participants must agree to abstain from egg or sperm donation through 60 days, after&#xD;
               administration of the last dose of study drug.&#xD;
  &#xD;
            8. Able to read and sign a written informed consent form (ICF).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Receiving any nonapproved agent intended for treatment of fibrosis in IPF or&#xD;
               Participation in other clinical trials.&#xD;
  &#xD;
            2. Clinical evidence of active infection, including but not limited to bronchitis,&#xD;
               pneumonia, or sinusitis that can affect FVC measurement during screening.&#xD;
  &#xD;
            3. Known acute IPF exacerbation or suspicion by the Investigator of such, within 3 months&#xD;
               of screening.&#xD;
  &#xD;
            4. The extent of emphysema is greater than the fibrotic changes on the most recent HRCT&#xD;
               scan as determined by PI.&#xD;
  &#xD;
            5. Any medical condition, not limited to cardiac, hepatic, renal disease or malignancy in&#xD;
               recent months that will make the patients ineligible for the study, as deemed&#xD;
               significant by PI.&#xD;
  &#xD;
            6. Any of the following liver function test criteria above specified limits: total&#xD;
               bilirubin &gt;2× the upper limit of normal (ULN); aspartate aminotransferase (AST) or&#xD;
               alanine aminotransferase (ALT) &gt;3× ULN; alkaline phosphatase &gt; 2.5× ULN, pending PI's&#xD;
               discretion.&#xD;
  &#xD;
            7. Hemoglobin levels &lt; 10.0 g/dL.&#xD;
  &#xD;
            8. Pregnant or lactating females.&#xD;
  &#xD;
            9. Likely to have lung transplantation during the study (being on transplantation list is&#xD;
               acceptable).&#xD;
  &#xD;
           10. Currently receiving and expected to remain on treatment during the study with:&#xD;
               amodiaquine, and efavirenz, nevirapine and ritonavir.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Joshua Mooney, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Stanford University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Stanford University</name>
        <address>
          <city>Stanford</city>
          <state>California</state>
          <zip>94305</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Stanford University</investigator_affiliation>
      <investigator_full_name>Joseph C. Wu</investigator_full_name>
      <investigator_title>Director, Stanford Cardiovascular Institute</investigator_title>
    </responsible_party>
    <keyword>shortness of breath, fibrosis, cough, hypoxemia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pulmonary Fibrosis</mesh_term>
      <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
      <mesh_term>Fibrosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Artesunate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05988463
  org study id: 71488
  nct id: NCT05988463
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive fibrotic lung disease resulting
        in increasing shortness of breath, cough, and low oxygen levels as a result of lung tissue
        scarring . The goal of this open-label (no placebo) study is to evaluate the safety and
        tolerability of artesunate at three different doses in patients with IPF. The secondary goals
        are to explore the blood biomarkers present in IPF patients at the beginning of the study and
        to study how those biomarkers change following treatment with artesunate. Participants will
        have 7 visits to the study site over 20 weeks which will include physician exams, vital
        signs, questionnaires, research and safety blood samples, and taking artesunate capsules by
        mouth for 12 weeks.
  
        Artesunate is used world-wide for the treatment of severe malaria but has also been found to
        block specific proteins that cause lung scarring and may provide an additional treatment to
        slow the fibrotic process in the lung and improve survival and quality of life for patients
        with IPF.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Open label, dose escalation treatment study
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of participants who experience treatment-related adverse events
  time frame: 12 weeks
  arm group label: Artesunate
  arm group type: Experimental
  intervention type: Drug
  intervention name: Artesunate Oral Product
  description: Artesunate capsules administered orally twice daily beginning at 10 mg for 4 weeks, followed by 20 mg for 4 weeks, and then 30 mg for 4 weeks.
  arm group label: Artesunate
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Joshua Mooney, MD
  role: Principal Investigator
  affiliation: Stanford University
  facility: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: Stanford University
  investigator full name: Joseph C. Wu
  investigator title: Director, Stanford Cardiovascular Institute
  mesh term: Pulmonary Fibrosis
  mesh term: Idiopathic Pulmonary Fibrosis
  mesh term: Fibrosis
  mesh term: Artesunate
  sharing ipd: No