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A Study to Observe the Long-term Safety of Odevixibat in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment

2026년 8월 28일 업데이트: Ipsen

Prospective Non-Interventional Study Evaluating the Long-term Safety of Odevixibat in Patients With Alagille Syndrome (ALGS)

This study will collect information from patients with ALGS who are using odevixibat in their daily lives. Odevixibat is a medication that helps patients with ALGS, a rare disease that affects the liver and causes itching.

The main aim of this study is to observe the long-term, everyday safety of the drug odevixibat in patients with ALGS who are receiving ongoing treatment.

연구 개요

상태

모병

정황

알라질 증후군

연구 유형

관찰

등록 (추정된)

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Ipsen Clinical Study Enquiries
전화번호: See e mail
이메일: clinical.trials@ipsen.com

연구 장소

이탈리아
- - Florence, 이탈리아
    - 모병
    - Azienda Ospedaliero Universitaria Meyer
  - Naples, 이탈리아
    - 아직 모집하지 않음
    - Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon
  - Padova, 이탈리아
    - 아직 모집하지 않음
    - University Hospital Of Padova
  - Roma, 이탈리아
    - 아직 모집하지 않음
    - Irccs Ospedale Pediatrico Bambino Gesu
  - Torino, 이탈리아
    - 아직 모집하지 않음
    - A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Infantile Regina Margherita
  - Udine, 이탈리아
    - 아직 모집하지 않음
    - Ospedale Universitario Di Udine
프랑스
- - Bron, 프랑스
    - 아직 모집하지 않음
    - Hospices Civils de Lyon - Hopital Femme Mere Enfant
  - Dijon, 프랑스
    - 아직 모집하지 않음
    - CHU Dijon Bourgogne
  - Le Kremlin-Bicêtre, 프랑스
    - 아직 모집하지 않음
    - APHP - Hopital Bicetre - Paris Sud
  - Marseille, 프랑스
    - 아직 모집하지 않음
    - APHM - CHU Timone
  - Montpellier, 프랑스
    - 아직 모집하지 않음
    - CHU de Montpellier - Hopital Saint Eloi
  - Paris, 프랑스
    - 아직 모집하지 않음
    - APHP - Hopital Necker-Enfants Malades
  - Toulouse, 프랑스
    - 아직 모집하지 않음
    - CHU de Toulouse - Hopital Paule de Viguier
  - Villejuif, 프랑스
    - 아직 모집하지 않음
    - APHP - Centre Hepato-Biliaire Hospital Paul Brousse

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

어린이
성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

Participants with Alagille syndrome (ALGS) who have been prescribed odevixibat by their treating physician will be enrolled into the study. Participants who started odevixibat treatment before study implementation may also be enrolled.

설명

Inclusion Criteria:

Diagnosed with ALGS.
On (or starting) active odevixibat treatment.
Aged 6 months or older at the time of consent.

Exclusion Criteria:

Currently participating in a clinical trial with odevixibat.
Currently participating in any interventional clinical trial for ALGS.
Have any contraindication to odevixibat as per the locally approved label.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Percentage of participants experiencing adverse events (AEs) 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection)	An adverse event (AE) is any untoward medical occurrence in a participant administered odevixibat, whether or not considered related to treatment.	From first ICF signature and up to end of data collection (approximately 5 years of data collection)
Percentage of participants experiencing serious adverse events (SAEs) 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection)	An adverse event (AE) is any untoward medical occurrence in a participant administered odevixibat, whether or not considered related to treatment.	From first ICF signature and up to end of data collection (approximately 5 years of data collection)

2차 결과 측정

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Ipsen

수사관

연구 책임자: Ipsen Medical Director, Ipsen

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 10일

기본 완료 (추정된)

2031년 9월 30일

연구 완료 (추정된)

2031년 9월 30일

연구 등록 날짜

최초 제출

2026년 5월 6일

QC 기준을 충족하는 최초 제출

2026년 5월 6일

처음 게시됨 (실제)

2026년 5월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 31일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 28일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

CLIN-60240-034

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications.

Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

IPD 공유 기간

Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.

IPD 공유 액세스 기준

Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

결과 측정	측정값 설명	기간
Percentage of participants with severe diarrhoea events 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection)		From first ICF signature and up to end of data collection (approximately 5 years of data collection)
Percentage of participants with bloody diarrhoea events 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection)		From first ICF signature and up to end of data collection (approximately 5 years of data collection)
Percentage of participants experiencing diarrhoea events with concurrent dehydration 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection)		From first ICF signature and up to end of data collection (approximately 5 years of data collection)
Percentage of participants experiencing diarrhoea events treated with oral or intravenous rehydration 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection)		From first ICF signature and up to end of data collection (approximately 5 years of data collection)
Change from baseline in fat-soluble vitamin (FSV) levels 기간: From baseline and up to end of data collection (approximately 5 years of data collection)		From baseline and up to end of data collection (approximately 5 years of data collection)
Percentage of participants with fat-soluble vitamin deficiency 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection)		From first ICF signature and up to end of data collection (approximately 5 years of data collection)
Percentage of participants with clinical manifestations of fat-soluble vitamin deficiency 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection)	For example, bleeding, rickets, or osteopenia.	From first ICF signature and up to end of data collection (approximately 5 years of data collection)
Percentage of participants with suspected hepatotoxicity requiring interruption of odevixibat treatment 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection)		From first ICF signature and up to end of data collection (approximately 5 years of data collection)
Percentage of participants with clinical manifestations related to hepatotoxicity 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection)		From first ICF signature and up to end of data collection (approximately 5 years of data collection)
Change from baseline in alanine aminotransferase (ALT) 기간: From baseline and up to end of data collection (approximately 5 years of data collection)		From baseline and up to end of data collection (approximately 5 years of data collection)
Change from baseline in aspartate aminotransferase (AST) 기간: From baseline and up to end of data collection (approximately 5 years of data collection)		From baseline and up to end of data collection (approximately 5 years of data collection)
Change from baseline in gamma-glutamyl transferase (GGT) 기간: From baseline and up to end of data collection (approximately 5 years of data collection)		From baseline and up to end of data collection (approximately 5 years of data collection)
Change from baseline in blood bilirubin 기간: From baseline and up to end of data collection (approximately 5 years of data collection)		From baseline and up to end of data collection (approximately 5 years of data collection)
Change from baseline in international normalized ratio (INR) 기간: From baseline and up to end of data collection (approximately 5 years of data collection)		From baseline and up to end of data collection (approximately 5 years of data collection)
Percentage of participants with hospitalisations due to diarrhoea 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection)		From first ICF signature and up to end of data collection (approximately 5 years of data collection)
Percentage of participants with hospitalisations due to hepatotoxicity 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection)		From first ICF signature and up to end of data collection (approximately 5 years of data collection)
Percentage of participants with hospitalisations due to fat-soluble vitamin deficiency 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection)		From first ICF signature and up to end of data collection (approximately 5 years of data collection)
Percentage of participants with treatment discontinuations due to diarrhoea 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection).		From first ICF signature and up to end of data collection (approximately 5 years of data collection).
Percentage of participants with treatment discontinuations due to hepatotoxicity 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection).		From first ICF signature and up to end of data collection (approximately 5 years of data collection).
Percentage of participants with treatment discontinuations due to fat-soluble vitamin deficiency 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection).		From first ICF signature and up to end of data collection (approximately 5 years of data collection).
Percentage of participants with pregnancy and maternal complications 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection)		From first ICF signature and up to end of data collection (approximately 5 years of data collection)
Percentage of foetuses, neonates, or infants with adverse effects following exposure to odevixibat during pregnancy and/or lactation 기간: From first documented exposure during pregnancy or lactation and up to end of data collection (approximately 5 years of data collection)		From first documented exposure during pregnancy or lactation and up to end of data collection (approximately 5 years of data collection)
Percentage of participants with biliary diversion surgery 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection)		From first ICF signature and up to end of data collection (approximately 5 years of data collection)
Percentage of participants with liver transplantation 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection)		From first ICF signature and up to end of data collection (approximately 5 years of data collection)
Percentage of participants who die from any cause 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection)		From first ICF signature and up to end of data collection (approximately 5 years of data collection)
Percentage of participants switching from odevixibat to maralixibat 기간: From first ICF signature and up to end of data collection (approximately 5 years of data collection)		From first ICF signature and up to end of data collection (approximately 5 years of data collection)