J-LINX: Japan LINerixibat eXtension Study
Japan Open-Label Linerixibat Safety and Tolerability Extension Study for Cholestatic Pruritus in PBC
This study evaluates the long-term safety and tolerability of linerixibat in Japanese adults with cholestatic pruritus in primary biliary cholangitis (PBC) who previously participated in the linerixibat long-term safety and efficacy study, LLSAT (NCT04167358). Participants will continue receiving linerixibat while researchers monitor adverse events and other safety measures to better understand the long-term safety of treatment and provide continued access to therapy.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：US GSK Clinical Trials Call Center
- 電話番号：877-379-3718
- メール：GSKClinicalSupportHD@gsk.com
研究連絡先のバックアップ
- 名前：EU GSK Clinical Trials Call Center
- 電話番号：+44 (0) 20 89904466
- メール：GSKClinicalSupportHD@gsk.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
-
Participants with a diagnosis of PBC and a history of associated pruritus as evidenced by randomization into an eligible linerixibat clinical study prior to LLSAT (GLIMMER or GLISTEN)
-
Participants must have completed the main treatment period in LLSAT
-
A Female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following applies:
- Is a woman of non-childbearing potential (WONCBP), OR
- Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method during the study intervention period (at a minimum until 4 weeks after the last dose of study intervention). The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated in relationship to the first dose of study intervention, etc.)
-
WOCBP must have a negative highly sensitive urine pregnancy test (or serum, as required by local regulations) within 7 days before the baseline visit
- If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
-
Capable of giving signed informed consent
Exclusion Criteria:
- Participants who met LLSAT protocol-defined Liver Monitoring or Liver Stopping criteria and who remain off study treatment or where Liver Event is not resolved at the Final Visit in LLSAT
- Presence of hepatic decompensation (e.g., current and unresolved variceal bleeding, encephalopathy, or ascites)
- Presence of confirmed hepatocellular carcinoma or biliary cancer
- Current clinically significant diarrhea in the investigator's medical opinion
- Any current medical condition (e.g., psychiatric disorder, senility, or dementia) which, in the investigator's opinion, may affect the participant's ability to comply with protocol-specified procedures
- Current enrollment or participation in any other clinical study (except for LLSAT) involving an investigational study treatment within 8 weeks prior to the Screening Visit
- Corrected QT Interval (QTc) >480 milliseconds (msec) at screening (12-lead Electrocardiogram [ECG]), subject to rescreening
研究計画
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Linerixibat
Participants with cholestatic pruritus associated with primary biliary cholangitis (PBC) who completed the LLSAT study will receive linerixibat. |
Linerixibat will be administered. |
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 |
|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
時間枠：Up to approximately 18 months (End of study)
|
Up to approximately 18 months (End of study)
|
|
Number of Participants With AEs by Severity
時間枠：Up to approximately 18 months (End of study)
|
Up to approximately 18 months (End of study)
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- 309859
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?
IPD プランの説明
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
IPD 共有時間枠
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
IPD 共有アクセス基準
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- 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
米国FDA規制機器製品の研究
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。