TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends
2026年7月26日 更新者：AOP Orphan Pharmaceuticals AG
Multicenter Registry Evaluating Real-World Therapeutic Patterns and Outcomes in Newly Diagnosed Adult Patients With Pulmonary Arterial Hypertension (PAH) Treated With Parenteral Treprostinil
TRESPECT is an international, multicenter, observational registry designed to describe the real-world use, effectiveness, and tolerability of parenteral treprostinil in adults with newly diagnosed pulmonary arterial hypertension (PAH). The registry will include patients who initiated subcutaneous or intravenous treprostinil within 12 months of PAH diagnosis.
Both retrospective and prospective data will be collected from routine clinical care. Data will include patient characteristics, PAH treatment patterns, treprostinil dosing and route of administration, functional status, exercise capacity, biomarkers, echocardiographic and hemodynamic parameters, clinical events, and adverse events. Participants will be followed for at least 36 months or until a registry termination criterion is met. The registry is expected to enroll approximately 100 to 300 patients across specialized PAH centers in several European countries.
調査の概要
研究の種類
観察的
入学 (推定)
300
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
確率サンプル
調査対象母集団
The registry will include approximately 100-300 adult patients (≥18 years of age) with confirmed pulmonary arterial hypertension (PAH), classified as Group 1 according to the prevailing ESC/ERS guidelines, who initiated parenteral treprostinil administered subcutaneously or intravenously on or after January 1, 2024.
Written informed consent will be required for prospective data collection and for retrospective medical chart review, as applicable under local regulations.
説明
Inclusion Criteria:
- Adult patient (≥18 years)
- Confirmed diagnosis of PAH (i.e. Group 1 as defined by ESC/ERS guidelines)
- Initiated on parenteral Treprostinil (SC or IV) anytime from 1/1/2024
- Informed consent (prospective data or retrospective chart review, per local regulations)
Exclusion Criteria:
- Participation in any interventional trials affecting PAH (including patients from TripleTRE study)
- Non-PAH forms of pulmonary hypertension (e.g., ESC-ERS Group 2-5)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Patients Treated With Parenteral Treprostinil
Adult patients with confirmed pulmonary arterial hypertension who initiated parenteral treprostinil administered by the subcutaneous or intravenous route within 12 months of PAH diagnosis.
Treatment selection, route of administration, dosing, titration, concomitant PAH therapy, and clinical management are determined by the treating physician according to routine clinical practice.
Clinical, treatment, safety, and outcome data are collected retrospectively and/or prospectively as part of this observational registry.
|
Parenteral treprostinil administered by continuous subcutaneous or intravenous infusion as part of routine clinical care.
The decision to initiate treatment, route of administration, starting dose, dose titration, treatment duration, and use of concomitant PAH therapies are determined by the treating physician and are not assigned by the registry.
Data on treatment initiation, doses at approximately 2 and 4 weeks, longitudinal dosing, route of administration, tolerability, local site reactions, pain, treatment changes, and clinical outcomes are collected during registry follow-up.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Change From Baseline in 6-Minute Walk Distance at Month 12
時間枠：Baseline and Month 12
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Mean change in 6-minute walk distance from baseline to Month 12.
The 6-minute walk distance is measured in meters.
A positive change indicates improvement in exercise capacity.
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Baseline and Month 12
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Number and Percentage of Participants by Change in New York Heart Association Functional Class at Month 12
時間枠：Baseline and Month 12
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Number and percentage of participants whose New York Heart Association Functional Class improved, remained unchanged, or worsened from baseline to Month 12. Functional Class ranges from Class I to Class IV, with a higher class indicating greater functional limitation.
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Baseline and Month 12
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Number and Percentage of Participants With Local Administration-Site Reactions During the First 12 Months
時間枠：From baseline through Month 12
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Number and percentage of participants experiencing at least one local administration-site reaction associated with subcutaneous or intravenous treprostinil application during the first 12 months after treatment initiation.
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From baseline through Month 12
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Mean Local Pain Score During the First 12 Months
時間枠：Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, and Month 12
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Local pain associated with parenteral treprostinil application will be assessed on a numerical rating scale from 0 to 10. Higher scores indicate greater pain.
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Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, and Month 12
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Change From Baseline in N-Terminal Pro-B-Type Natriuretic Peptide at Month 12
時間枠：Baseline and Month 12
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Mean change in N-terminal pro-B-type natriuretic peptide concentration from baseline to Month 12.
|
Baseline and Month 12
|
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Mean Change From Baseline in B-Type Natriuretic Peptide at Month 12
時間枠：Baseline and Month 12
|
Mean change in B-type natriuretic peptide concentration from baseline to Month 12.
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Baseline and Month 12
|
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Overall survival
時間枠：From initiation of parenteral treprostinil until death from any cause, assessed up to 36 months
|
Overall survival is defined as the time from initiation of parenteral treprostinil to death from any cause.
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From initiation of parenteral treprostinil until death from any cause, assessed up to 36 months
|
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Number and Percentage of Participants by Reason for Early Initiation of Parenteral Treprostinil
時間枠：Baseline
|
Number and percentage of participants in each documented category of clinical reason for initiating parenteral treprostinil within 12 months of PAH diagnosis, irrespective of baseline risk category.
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Baseline
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Mean Parenteral Treprostinil Dose at each visit
時間枠：Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
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Parenteral treprostinil dose will be summarized at each visit.
Dose will be reported in the unit ng/kg/min.
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Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
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Number and Percentage of Participants by Route of Parenteral Treprostinil Administration
時間枠：Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
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Number and percentage of participants receiving parenteral treprostinil by subcutaneous or intravenous administration at each visit.
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Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
|
|
Number and Percentage of Participants Receiving Concomitant Pulmonary Arterial Hypertension Therapy
時間枠：Baseline, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
|
Number and percentage of participants receiving each recorded category of concomitant pulmonary arterial hypertension therapy.
|
Baseline, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
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Time to First Composite Clinical Worsening Event
時間枠：From initiation of parenteral treprostinil until the first composite clinical worsening event, assessed up to 36 months
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Time from initiation of parenteral treprostinil to the first occurrence of death from any cause, PAH-related hospitalization, or lung transplantation.
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From initiation of parenteral treprostinil until the first composite clinical worsening event, assessed up to 36 months
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Number and Percentage of Participants With Adverse Events
時間枠：From baseline through Month 36
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Number and percentage of participants experiencing at least one adverse event during registry follow-up.
Adverse events will be summarized by seriousness, severity, outcome, causal relationship to treprostinil, and action taken with treatment.
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From baseline through Month 36
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2029年12月1日
研究の完了 (推定)
2031年12月1日
試験登録日
最初に提出
2026年7月20日
QC基準を満たした最初の提出物
2026年7月26日
最初の投稿 (実際)
2026年7月30日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月30日
QC基準を満たした最後の更新が送信されました
2026年7月26日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- TRESPECT
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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