Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC) (ROXI-PEAK)
2026年7月6日 更新者：Regeneron Pharmaceuticals
A Master Protocol for a Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, for Prophylaxis of Venous Thromboembolism in Participants With a Peripherally Inserted Central Catheter (PICC) (ROXI-PEAK)
This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called "study drugs"). The study is focused on people who have a tube placed in a vein to receive treatment (called Peripherally Inserted Central Catheter [PICC]). Patients with PICCs have a higher risk of getting blood clots which can block the veins (this is called Venous Thromboembolism [VTE]) and lead to serious health problems or be life threatening.
The aim of the study is to see how well REGN7508 and REGN9933 prevent blood clots compared to placebo after PICC placement and to see if these medications cause certain types of bleeding.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drugs
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)
- If the study drugs affect the ability of the blood to clot normally
調査の概要
研究の種類
介入
入学 (推定)
1908
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Clinical Trials Administrator
- 電話番号：844-734-6643
- メール：clinicaltrials@regeneron.com
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
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Key Inclusion Criteria:
- Is undergoing PICC placement for Intravenous (IV) administration of clinically indicated medications, including chemotherapy, antibiotics, TPN, and/or other indications as described in the protocol
- Has Eastern Cooperative Oncology Group Performance (ECOG) Status ≤3 or equivalent functional status as described in the protocol
- Has International Normalization Ratio (INR) and aPTT values no more than 25% above the upper limit as described in the protocol
- Weighs at least 40 kg during the screening period
Key Exclusion Criteria:
- Has a history of prior venous thrombosis in the arm and/or ipsilateral thoracic central veins in which the PICC is to be placed
- Has acute leukemia, myelodysplastic syndrome, or primary and secondary myelofibrosis
- Has unresected luminal gastrointestinal (GI) (including esophageal) or unresected genitourinary (GU) malignancy
- Has current or history of known brain tumors or brain metastases
- Has any major cardiovascular event within approximately the past 30 days prior to study administration
- Pre-existing central venous catheter or indwelling spinal or epidural catheter during the screening period
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：プラセボ
|
プロトコルに従って管理される
|
|
実験的：REGN7508
|
プロトコルごとに管理されます
他の名前：
|
|
実験的：Regn9933
|
プロトコルごとに管理されます
他の名前：
|
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 |
時間枠 |
|---|---|
|
Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE]
時間枠：Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of centrally adjudicated International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding or Clinically Relevant Non-Major (CRNM) bleeding
時間枠：Approximately 6 months
|
Approximately 6 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Time-to-first event of centrally adjudicated symptomatic VTE [symptomatic Deep Vein Thrombosis (DVT) or symptomatic non-fatal Pulmonary Embolism (PE) or VTE-related death]
時間枠：Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of symptomatic DVT
時間枠：Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of symptomatic non-fatal PE
時間枠：Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of VTE-related death
時間枠：Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of incidental VTE
時間枠：Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT
時間枠：Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of incidental PE (in a segmental or larger pulmonary artery)
時間枠：Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by upper extremity ultrasound)
時間枠：Approximately 6 months
|
Approximately 6 months
|
|
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
時間枠：Up to approximately 9 months
|
Up to approximately 9 months
|
|
Severity of TEAEs
時間枠：Up to approximately 9 months
|
Up to approximately 9 months
|
|
Concentrations of REGN7508
時間枠：Up to approximately 9 months
|
Up to approximately 9 months
|
|
Concentrations of REGN9933
時間枠：Up to approximately 9 months
|
Up to approximately 9 months
|
|
Change from baseline in activated Partial Thromboplastin Time (aPTT)
時間枠：Up to approximately 9 months
|
Up to approximately 9 months
|
|
Change from baseline in Prothrombin Time (PT)
時間枠：Up to approximately 9 months
|
Up to approximately 9 months
|
|
Occurrence of Anti-Drug Antibody (ADA) to REGN7508
時間枠：Up to approximately 9 months
|
Up to approximately 9 months
|
|
Magnitude of ADA to REGN7508
時間枠：Up to approximately 9 months
|
Up to approximately 9 months
|
|
Occurrence of ADA to REGN9933
時間枠：Up to approximately 9 months
|
Up to approximately 9 months
|
|
Magnitude of ADA to REGN9933
時間枠：Up to approximately 9 months
|
Up to approximately 9 months
|
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。
捜査官
- スタディディレクター：Clinical Trial Management、Regeneron Pharmaceuticals
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8月20日
一次修了 (推定)
2029年6月25日
研究の完了 (推定)
2029年9月21日
試験登録日
最初に提出
2026年7月6日
QC基準を満たした最初の提出物
2026年7月6日
最初の投稿 (実際)
2026年7月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月13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6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
キーワード
その他の研究ID番号
- R7508-DVT-25103
- 2026-525288-42-00 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD 共有時間枠
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
IPD 共有アクセス基準
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli.
Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。