Clinical trials: Biliary Diseases
Biliary Tract Cancer
A Study of AK130 in Combination With AK112 for the Treatment of Advanced Biliary Tract Cancer
There're 2 parts in this interventional study: 1. The goal of phase Ib trial is to evaluate the safety and tolerability of AK130 in combination with AK112 therapy for the purpose of observing the incidence of dose limit toxicity…
- Trial name
- NCT06938321
- Testing
- AK112, AK130
- Where
- China
- Volunteers
- 135 people
- Sponsor
- Akeso
Adenocarcinoma, Adenocystic Carcinoma
The Registry of Oncology Outcomes Associated With Testing and Treatment
This study is to collect and validate regulatory-grade real-world data (RWD) in oncology using the novel, Master Observational Trial construct. This data can be then used in real-world evidence (RWE) generation.
- Conditions
- Adenocarcinoma, Adenocystic Carcinoma, Anal Cancer, Appendix Cancer
- Trial name
- ROOT (NCT04028479)
- Testing
- Biomarker Testing (L), Systemic Treatment (T), Patient Reported Outcomes (P)
- Where
- 2 sites in United States
- Volunteers
- 167 people
- Sponsor
- Taproot Health
Primary Biliary Cholangitis
A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
This is an observational, retrospective cohort study, using the UK PBC registry, comparing patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment and were treated with obeticholic acid…
- Trial name
- HEROES-PBC (NCT05293938)
- Testing
- Obeticholic Acid 5 MG, Obeticholic Acid 10 MG, Standard of Care: UDCA
- Where
- United States
- Sponsor
- Intercept Pharmaceuticals
Neoplasms
Phase 1 Dose Escalation Study for VIP236 in Patients With Advanced Cancer
Determine the safety, tolerability, and maximum tolerated dose (MTD) of IV administered VIP236 as monotherapy in patients with advanced solid tumor cancer
- Trial name
- NCT05712889
- Testing
- VIP236 (Q3W), VIP236 (Q2W)
- Where
- 6 sites in United States, Australia
- Volunteers
- 29 people
- Sponsor
- Vincerx Pharma, Inc.
Pruritus
J-LINX: Japan LINerixibat eXtension Study
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…
- Trial name
- NCT07860710
- Testing
- Linerixibat
- Volunteers
- 40 people
- Sponsor
- GlaxoSmithKline
Biliary Tract Cancer
A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer
This study is a multicenter, open-label, single-arm phase II study to evaluate efficacy, safety, and pharmacokinetics characteristics of HA121-28 tablets in advanced biliary tract cancer (BTC).
- Trial name
- NCT04784520
- Testing
- HA121-28 tablets
- Where
- 2 sites in China
- Volunteers
- 31 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Biliary Tract Neoplasms
Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers
This is a Randomized, Open-Label, Multicenter Phase 2 Study to access the efficacy and safety of Envafolimab in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin as the First-line Treatment in Patients…
- Trial name
- NCT04910386
- Testing
- Envafolimab plus Gemcitabine&Cisplatin, Gemcitabine&Cisplatin
- Volunteers
- 126 people
- Sponsor
- 3D Medicines (Sichuan) Co., Ltd.
Breast Cancer, Biliary Tract Carcinoma
A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
This research study is studying a new compound, AZD8205, as a possible treatment for advanced or metastatic solid tumours alone or in combination with anti-cancer agents
- Conditions
- Breast Cancer, Biliary Tract Carcinoma, Ovarian Cancer, Endometrial Cancer
- Trial name
- NCT05123482
- Testing
- AZD8205, AZD8205 and AZD2936 (Rilvegostomig), AZD8205 and AZD5305 (saruparib)
- Where
- 67 sites in United States, Australia and 13 more
- Volunteers
- 460 people
- Sponsor
- AstraZeneca
Biliary Tract Neoplasms, Pancreatic Neoplasms
Malignant Obstruction ZILVER Against Routine Therapy (MOZART I)
This study compares the 6 mm nitinol Zilver biliary endoprostheses and the 10 mm nitinol Zilver biliary endoprostheses to the 10 mm Wallstent in appropriate patients in need of palliative treatment of malignant obstructive…
- Conditions
- Biliary Tract Neoplasms, Pancreatic Neoplasms, Jaundice, Obstructive
- Trial name
- NCT00196105
- Testing
- 6 mm Nitinol Zilver Stent, 10 mm Nitinol Zilver Stent, 10 mm Stainless Steel Wallstent
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- Cook Group Incorporated
Primary Biliary Cirrhosis
Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis
The purpose of this study is to compare the efficacy of Ursofalk 500 mg tablets versus Ursofalk 500 mg capsules in the treatment of Primary Biliary Cirrhosis (PBC).
- Trial name
- NCT01510860
- Testing
- UDCA (Ursodeoxycholic acid)
- Where
- Germany
- Volunteers
- 65 people
- Sponsor
- Dr. Falk Pharma GmbH
Acute Cholecystitis, Acute; Cholecystitis, Choledocholithiasis
Indocyanine Green to Visualize Critical View of Safety During Laparoscopic Cholecystectomy for Acute Cholecystitis
The purpose of this prospective randomized trial is to study the role of Indocyanine green (ICG) to visualize the Critical View of Safety during emergency Laparoscopic Cholecystectomy for patients with Acute Cholecystitis.
- Conditions
- Acute Cholecystitis, Acute; Cholecystitis, Choledocholithiasis, Acute Cholecystitis With Obstruction
- Trial name
- NCT04624841
- Testing
- Indocyanine Green
- Where
- Qatar
- Volunteers
- 80 people
- Sponsor
- Hamad Medical Corporation
Primary Biliary Cholangitis
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).
- Trial name
- NCT06488911
- Testing
- FDC tablet (OCA 5 mg + BZF 400 mg SR)
- Where
- 51 sites in United States, Argentina and 19 more
- Volunteers
- 62 people
- Sponsor
- Intercept Pharmaceuticals
Biliary Tract Cancer
AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer
This is a phase 3 study. All subjects are patients with unresectable locally advanced or metastatic biliary tract cancer (BTC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Trial name
- NCT06591520
- Testing
- AK112, Gemcitabine, Cisplatin, Durvalumab, Gemcitabine, Cisplatin
- Where
- 2 sites in China
- Volunteers
- 682 people
- Sponsor
- Akeso
Primary Sclerosing Cholangitis
Study of Cilofexor in Adults With Primary Sclerosing Cholangitis
The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).
- Trial name
- PRIMIS (NCT03890120)
- Testing
- Cilofexor
- Where
- 201 sites in United States, Australia and 14 more
- Volunteers
- 419 people
- Sponsor
- Gilead Sciences
HER2-amplified Biliary Tract Cancers
A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers
This multicenter, open-label, single-arm trial will evaluate the anti-tumor activity of ZW25 (zanidatamab) monotherapy in subjects with human epidermal growth factor receptor 2 (HER2)-amplified, inoperable and advanced or…
- Trial name
- HERIZON-BTC-01 (NCT04466891)
- Testing
- ZW25 (Zanidatamab)
- Where
- 67 sites in United States, Canada and 7 more
- Volunteers
- 87 people
- Sponsor
- Jazz Pharmaceuticals
Obesity
Study Of The Safety And Pharmacokinetics Of CE-326,597 In Patients With Asymptomatic Gallstones
The study is designed to assess whether repeated dosing with CE-326,597 will cause patients with asymptomatic gallstones (as detected on screening abdominal ultrasound) to become symptomatic.
- Trial name
- NCT00576589
- Testing
- CE-326,597
- Where
- 12 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Pfizer
Biliary Tract Cancer
A Study of TQB2102 for Injection in the Treatment of HER2-positive Biliary Tract Cancer
To evaluate the efficacy and safety TQB2102 for injection in the treatment of patients with Her2-positive biliary tract cancer.
- Trial name
- NCT06431490
- Testing
- TQB2102 for injection
- Where
- 43 sites in China
- Volunteers
- 102 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Primary Sclerosing Cholangitis, Cholangitis
A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)
Randomized, double-blind, active-controlled, parallel-group study of HTD1801 in adolescents.
- Conditions
- Primary Sclerosing Cholangitis, Cholangitis, Cholangitis, Sclerosing, Bile Duct Diseases
- Trial name
- NCT03678480
- Testing
- HTD1801, Ursodeoxycholic Acid
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Cholestasis
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects
In participants with inadequate response/intolerance to ursodeoxycholic acid (UDCA) taking obeticholic acid (OCA) who experience pruritus (due to primary biliary cholangitis [PBC], OCA, or both) the addition of linerixibat to OCA…
- Trial name
- NCT04053023
- Testing
- GSK2330672 (linerixibat), Obeticholic acid
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bacterial Infections and Mycoses, Appendicitis
Doripenem in the Treatment of Complicated Intra-Abdominal Infections
The purpose of this study is to compare the clinical response rate of doripenem versus a comparator in the treatment of hospitalized patients with complicated intra-abdominal infections.
- Conditions
- Bacterial Infections and Mycoses, Appendicitis, Cholecystitis, Pancreatitis
- Trial name
- NCT00229060
- Testing
- doripenem
- Volunteers
- 483 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.