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PTG-300 in Subjects With Hereditary Hemochromatosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04202965
Recruitment Status : Completed
First Posted : December 18, 2019
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Protagonist Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE December 16, 2019
First Posted Date  ICMJE December 18, 2019
Last Update Posted Date March 2, 2022
Actual Study Start Date  ICMJE March 19, 2020
Actual Primary Completion Date October 6, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2019)
  • Effect of PTG-300 on Transferrin Saturation [ Time Frame: Week 24 ]
    Change in transferrin saturation (TSAT) as measured by blood laboratory tests.
  • Effect of PTG-300 on Serum Iron [ Time Frame: Week 24 ]
    Change in serum iron as measured by blood laboratory tests.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2019)
  • Effect of PTG-300 on Phlebotomy Frequency [ Time Frame: Week 24 ]
    Change in phlebotomy frequency as measured by number of phlebotomies over a 24 week period.
  • SF-36 [ Time Frame: Week 24 ]
    The SF-36 is a participant-reported outcome measure. The instrument includes 36 items in a Likert-type format to measure the following health dimensions over the past week: limitations in physical activities; limitations in social activities; limitations in usual role activities; bodily pain; general mental health; vitality; and general health perceptions.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PTG-300 in Subjects With Hereditary Hemochromatosis
Official Title  ICMJE Open-label Study of PTG-300 in Subjects With Hereditary Hemochromatosis
Brief Summary This study will be conducted at multiple sites and every patient will get treated with PTG-300. The objective of the study is to assess the effect of PTG-300 in treating adult hereditary hemochromatosis patients.
Detailed Description This study is a multicenter, open-label study. The objective of the study is to assess the effect of PTG-300 on transferrin saturation (TSAT) and serum iron in adult hereditary hemochromatosis patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single Arm Study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hereditary Hemochromatosis
Intervention  ICMJE Drug: PTG-300
Active treatment with PTG-300 subcutaneously
Study Arms  ICMJE Experimental: PTG-300
PTG-300 Subcutaneous
Intervention: Drug: PTG-300
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2022)
16
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2019)
28
Actual Study Completion Date  ICMJE February 15, 2022
Actual Primary Completion Date October 6, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women aged 18 and older
  • Confirmed diagnosis of HFE-related hereditary hemochromatosis with prior genotype testing
  • Documented stable phlebotomy for ≥ 6 months
  • Screening hemoglobin >11.5 g/dL
  • Documented evidence of prior serum ferritin ≥500 ng/mL
  • Serum ferritin >50 ng/mL and <300 ng/mL at screening

Exclusion Criteria:

  • Clinically meaningful laboratory abnormality
  • Receiving iron chelation therapy
  • Receiving erythrocytapheresis
  • Pregnant or lactating females
  • Infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 3 months of dosing; any infections requiring antimicrobial therapy within 4 weeks of dosing.
  • Serious or unstable medical or psychiatric condition that would prevent subject providing informed consent
  • Organ damage from iron overload
  • Primary or secondary immunodeficiency
  • Positive hepatitis B or hepatitis C or known human immunodeficiency virus infection
  • Known history of autoimmune/inflammatory diseases
  • Any surgical procedures requiring general anesthesia within 1 month prior to screening or planned surgery during study
  • History of invasive malignancies within last 2 years, except non-malignant skin cancer and local cured prostrate cancer, cervical cancer, or ductal carcinoma in situ
  • Receipt of an investigational agent within 30 days of screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04202965
Other Study ID Numbers  ICMJE PTG-300-06
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Protagonist Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Protagonist Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Protagonist Therapeutics, Inc.
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP