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Trial record 1 of 1 for:    TDE-HF-302
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Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF

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ClinicalTrials.gov Identifier: NCT03043651
Recruitment Status : Terminated (Terminated by Sponsor)
First Posted : February 6, 2017
Results First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
United Therapeutics

Tracking Information
First Submitted Date  ICMJE January 31, 2017
First Posted Date  ICMJE February 6, 2017
Results First Submitted Date  ICMJE September 25, 2020
Results First Posted Date  ICMJE October 22, 2020
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE January 30, 2018
Actual Primary Completion Date March 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2020)
Long-term Safety of Oral Treprostinil in Subjects With PH Associated With HFpEF for Subjects Who Completed Study TDE-HF-301 [ Time Frame: Baseline through study completion, up to approximately 25 months ]
The primary objective of this study was to evaluate the long-term safety of oral treprostinil in subjects with PH associated with HFpEF for subjects who completed Study TDE-HF-301. The number of subjects with adverse events during the study is reported as the primary outcome measure, which was the only outcome measurement reported for this Sponsor-terminated study.
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
  • Long-term Safety of Oral Treprostinil in Subjects with PH Associated with HFpEF as assessed by number of subjects with treatment-related adverse events [ Time Frame: Baseline through study completion, up to approximately 8 years ]
  • Long-term Safety of Oral Treprostinil in Subjects with PH Associated with HFpEF as assessed by clinical laboratory parameters [ Time Frame: Baseline through study completion, up to approximately 8 years ]
  • Long-term Safety of Oral Treprostinil in Subjects with PH Associated with HFpEF as assessed by number of subjects with heart failure signs and symptoms [ Time Frame: Baseline through study completion, up to approximately 8 years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
  • Effect of Continued Long-term Oral Treprostinil Therapy on the 6-Minute Walk Distance (6MWD) [ Time Frame: Baseline through study completion, up to approximately 8 years ]
    The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.
  • Effect of Continued Long-term Oral Treprostinil Therapy on the Borg Dyspnea Score [ Time Frame: Baseline through study completion, up to approximately 8 years ]
    The Borg dyspnea score is a 10 point scale rating the maximum level of dyspnea experienced during the 6MWT. Scores range from 0 (for the best condition) to 10 (for the worst condition).
  • Effect of Continued Long-term Oral Treprostinil Therapy on World Health Organization (WHO) Functional Class [ Time Frame: Baseline through study completion, up to approximately 8 years ]
    The WHO functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment).
  • Effect of Continued Long-term Oral Treprostinil Therapy on the N-Terminal Pro-brain Natriuretic Peptide (NT-proBNP) [ Time Frame: Baseline to Weeks 24 and 48 ]
    The NT-proBNP is a biomarker associated with changes in right heart morphology and function.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF
Official Title  ICMJE An Open-label Extension Study of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) Associated With Heart Failure With Preserved Ejection Fraction (HFpEF) - A Long-term Follow-up to Study TDE-HF-301
Brief Summary

This was an open-label study to evaluate the safety of continued therapy with oral treprostinil in subjects who completed Study TDE-HF-301. This study provided long-term, open-label data regarding the effect of continued long-term oral treprostinil therapy for the treatment of pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Subject visits occurred at Baseline, Weeks 6, 12, 18, 24, and every 12 weeks thereafter until either oral treprostinil was commercially available to treat PH associated with HFpEF or the study was discontinued by the Sponsor.

The Sponsor terminated Studies TDE-HF-301 and TDE-HF-302 on 14 October 2019 due to slow enrollment. Safety data from the final subject in Study TDE-HF-302 were recorded on 02 March 2020. Due to the lower than expected number of subjects enrolled, the planned secondary efficacy-related endpoints were not analyzed.

Detailed Description

Study TDE-HF-302 was a multicenter, open-label study in subjects participating and completing all required visits for Study TDE-HF-301. This study assessed the long-term safety of oral treprostinil in subjects with PH associated with HFpEF.

Subjects received oral treprostinil as 0.125-, 0.25-, 1-, and 2.5-mg sustained-release tablets. For subjects who were randomly allocated to receive oral treprostinil in Study TDE-HF-301, the initial dose of oral treprostinil was the same as the final dose in Study TDE-HF-301. Subjects randomly allocated to receive placebo in Study TDE-HF-301 were administered the initial dose of oral treprostinil at 0.125 mg 3 times daily (TID). Dose increases could occur in 0.125-mg increments every 72 hours at the discretion of the Investigator up to 6 mg TID, the maximum allowable dose determined by the Data Monitoring Committee during Study TDE-HF-301. Doses of study drug were to be increased in the absence of dose-limiting drug-related adverse events (AEs) to ensure that each subject received the optimal dose throughout the study. Subjects returned for visits at Weeks 6, 12, 18, and 24, and every 12 weeks thereafter. Subjects who terminated the study early were asked to return to the study center for a final evaluation.

Safety assessments consisted of AEs, clinical laboratory parameters, and clinical assessment of heart failure signs and symptoms.

Due to the lower than expected number of subjects enrolled, the planned secondary efficacy-related endpoints were not analyzed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Hypertension Associated With HFpEF
Intervention  ICMJE Drug: Oral treprostinil
Sustained-release oral tablets for TID administration
Other Name: Treprostinil diethanolamine, Treprostinil diolamine
Study Arms  ICMJE Experimental: Oral treprostinil
Sustained-release tablets for TID administration
Intervention: Drug: Oral treprostinil
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 Terminated
Actual Enrollment  ICMJE
 (submitted: April 16, 2020)
48
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2017)
310
Actual Study Completion Date  ICMJE March 2, 2020
Actual Primary Completion Date March 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. The subject participated in Study TDE-HF-301, remained on study drug, was compliant with study procedures and assessments during Study TDE-HF-301, and completed through Week 24 of that study.

Exclusion Criteria:

  1. The subject was pregnant or lactating.
  2. The subject was prematurely discontinued from Study TDE-HF-301 for any reason.
  3. The subject developed a concurrent illness or condition during Study TDE-HF-301, which, in the opinion of the Investigator, represented a risk to the subject's overall health if they enrolled in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03043651
Other Study ID Numbers  ICMJE TDE-HF-302
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
Responsible Party United Therapeutics
Study Sponsor  ICMJE United Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mardi Gomberg-Maitland, MD George Washington University
PRS Account United Therapeutics
Verification Date September 2020

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