Vlissingen, Netherlands
Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults.
Phase
3Span
250 weeksSponsor
PfizerSan Antonio, Texas
Recruiting
Healthy Volunteers
Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome
This Phase 3, open-label, multi-center extension study will have two groups of participants: Cohort 1 (participants who participated in Study A4250-012 [NCT04674761; ASSERT] and meet the entry criteria for this study) and Cohort 2 (infants under 12 months of age) with ALGS. The study will consist of 2 or 3 periods: 1. A 'Treatment period' of 72 weeks (cohort 1) or 12 weeks (cohort 2). Participants will visit the clinic every 4 to 12 weeks and will receive a dose of 120 μg/kg odevixibat daily. 2. An 'Optional extension period' where participants who wish to continue receiving odevixibat after the 'treatment period' will have the opportunity to remain on treatment with visits every 16 weeks until the drug is commercially available. The optional extension is available provided continued use is supported by the risk-benefit profile, the participant has not been previously withdrawn or discontinued from the study, and the study is not terminated by the Sponsor. 3. A 'Safety follow-up period' of 4 weeks (cohort 1) or 2 weeks (cohort 2). The Safety Follow-up Period will not occur for those who remain on treatment in the optional extension period. Participants will need to complete an e-diary and questionnaires throughout the study (cohort 1 only). Participants will undergo blood samplings, urine collections (cohort 1 only), physical examinations, and clinical evaluations. They may continue some other medications, but the details need to be recorded.
Phase
3Span
240 weeksSponsor
Albireo, an Ipsen CompanySan Antonio, Texas
Recruiting
A Study to Test How Well BI 770371 is Tolerated by People With Cirrhosis Caused by a Liver Disease Called MASH
Phase
2Span
49 weeksSponsor
Boehringer IngelheimSan Antonio, Texas
Recruiting
A Research Study on Etavopivat in Participants With and Without Liver Disease
Phase
1Span
66 weeksSponsor
Novo Nordisk A/SSan Antonio, Texas
Recruiting
Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
This is a randomized, double-blind, multicenter, parallel-group Phase IIIb study with a fixed treatment period of 52 weeks. The study will consist of 3 periods: 1. Screening period (7 to 28 days) 2. Treatment period of 52 weeks 3. Safety follow-up period (7 to 14 days after the end of treatment [EOT] visit) Participants who meet the eligibility criteria will be randomly assigned to BDA MDI 160/180 micrograms (μg) or AS MDI 180 μg treatment groups in a 1:1 ratio on top of their own usual maintenance therapy during treatment period. This study will also include a pharmacokinetic (PK) sub-study with single visit scheduled after the safety follow-up visit in the main study. During PK sub-study, single dose of open-label BDA MDI 160/180 μg will be administered.
Phase
3Span
178 weeksSponsor
AstraZenecaSan Antonio, Texas
Recruiting
A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
Phase
3Span
121 weeksSponsor
IpsenSan Antonio, Texas
Recruiting
Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease
Phase
2Span
87 weeksSponsor
Novo Nordisk A/SSan Antonio, Texas
Recruiting
A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment
Phase
1Span
65 weeksSponsor
Bristol-Myers SquibbSan Antonio, Texas
Recruiting
Healthy Volunteers
San Antonio, Texas
Recruiting
Dose Exploration Study of GSK4532990 in. Participants With NASH or Suspected NASH
Phase
2Span
88 weeksSponsor
GlaxoSmithKlineSan Antonio, Texas
Recruiting