Clinical trials: Disorders of Biliary Tract
Colorectal Cancer, Gastro Esophageal Junctional Cancer
IKS04 Regimen in Advanced Solid Tumors That Express CA242
This study will evaluate the safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of the IKS04 Regimen and identify a recommended phase 2 dose (RP2D) or recommended dose for further…
- Conditions
- Colorectal Cancer, Gastro Esophageal Junctional Cancer, Gastric Cancer (GC), GEJ Adenocarcinoma
- Trial name
- NCT07738939
- Testing
- IKS04 antibody drug conjugate ADC + Isumab04 monoclonal antibody
- Where
- 4 sites in United States
- Volunteers
- 120 people
- Sponsor
- Iksuda Therapeutics Ltd.
Alagille Syndrome
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus placebo on the biochemical markers and…
- Trial name
- IMAGO (NCT01903460)
- Testing
- LUM001
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Gastric Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction
A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer
The main purpose of this study is to evaluate the safety and preliminary efficacy of the combination of the study drug known as ramucirumab plus pembrolizumab in participants with locally advanced and unresectable or metastatic…
- Conditions
- Gastric Adenocarcinoma, Adenocarcinoma of the Gastroesophageal Junction, Non-small Cell Lung Cancer, Carcinoma, Transitional Cell
- Trial name
- NCT02443324
- Testing
- Ramucirumab, Pembrolizumab
- Where
- 22 sites in United States, France and 4 more
- Volunteers
- 175 people
- Sponsor
- Eli Lilly and Company
Primary Biliary Cirrhosis
Pilot Study of FFP104 Dose Escalation in PBC Subjects
The purpose of this study is to determine the initial safety, tolerability and pharmacodynamics of the CD40-antagonist Mab, FFP104, in subjects with PBC
- Trial name
- NCT02193360
- Testing
- FFP104
- Where
- 5 sites in Netherlands, United Kingdom
- Volunteers
- 24 people
- Sponsor
- Fast Forward Pharmaceuticals
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 Cancer
A Study of Selective HDAC6 Inhibition With KA2507 in Advanced Biliary Tract Cancer
To evaluate the preliminary efficacy of KA2507 (an orally active potent and selective HDAC6 inhibitor) in patients with advanced biliary tract cancer (BTC) previously treated with standard of care chemotherapy.
- Trial name
- NCT04186156
- Testing
- KA2507
- Where
- United Kingdom
- Sponsor
- Karus Therapeutics Limited
Biliary Tract Cancer
A Study of RC48-ADC in Subjects With HER2 Overexpressed Metastatic Biliary Tract Cancer
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with locally advanced or metastatic HER2 overexpressed biliary tract cancer who have failed first-line chemotherapy.
- Trial name
- NCT04329429
- Testing
- RC48-ADC
- Where
- 16 sites in China
- Volunteers
- 57 people
- Sponsor
- RemeGen Co., Ltd.
Primary Biliary Cholangitis
Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
This is an observational, retrospective cohort study of patients with primary biliary cholangitis (PBC) who failed ursodeoxycholic acid (UDCA) treatment, using a real-world data source, the Komodo Health United States (US) claims…
- Trial name
- HEROES PBC (NCT05292872)
- Where
- United States
- Volunteers
- 4,577 people
- Sponsor
- Intercept Pharmaceuticals
Abscess, Intra-Abdominal, Cholecystitis
Cefoperazone/Sulbactam In The Treatment Of Serious Intra-Abdominal And Hepatobiliary Infections.
The primary objective is to collect data on treatment outcomes (clinical and microbiological cure), safety and tolerability of treatment with cefoperazone/sulbactam in patients with serious intra-abdominal and hepatobiliary…
- Conditions
- Abscess, Intra-Abdominal, Cholecystitis, Wound Infections, Peritonitis
- Trial name
- NCT00463762
- Testing
- CP-75385-02 Cefoperazone/sulbactam
- Sponsor
- Pfizer
Biliary Tract Cancer
A Trial Evaluating Surufatinib Efficacy and Safety in Biliary Tract Carcinoma Patients
This is a randomized, open-label, active-control, multi-center, phase IIb/III clinical study to evaluate the efficacy and safety of surufatinib vs.
- Trial name
- NCT03873532
- Testing
- Surufatinib, Capecitabine
- Where
- China
- Volunteers
- 298 people
- Sponsor
- Hutchison Medipharma Limited
Alagille Syndrome
A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
This study will collect information from patients with Alagille syndrome (ALGS) as they use odevixibat (Bylvay) in their daily lives.
- Trial name
- NCT06850038
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ipsen
PFIC - Progressive Familial Intrahepatic Cholestasis
A Study to Assess the Genetic Variations in Bile Flow Disorders: Linking Progressive Familial Intrahepatic Cholestasis (PFIC)-Related Genes to Symptoms in Adults With Recurrent Cholestasis in Spain
Progressive Familial Intrahepatic Cholestasis (PFIC) is a group of inherited conditions that affect how bile moves in the liver, which can lead to serious liver problems.
- Trial name
- REGENIC (NCT07191704)
- Where
- 10 sites in Spain
- Volunteers
- 150 people
- Sponsor
- Ipsen
Primary Biliary Cholangitis (PBC)
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
The purpose of this study is to understand how tiredness changes in adults with Primary Biliary Cholangitis (PBC) after starting elafibranor in routine clinical practice.
- Trial name
- NCT07906639
- Testing
- Elafibranor
- Volunteers
- 50 people
- Sponsor
- Ipsen
Intestinal Failure-associated Liver Disease
Prevalence of Liver Disease in Patients Dependent on Parenteral Nutrition
This is a multi-center prospective cross-sectional observational study that will assess the prevalence of liver disease in patients dependent on parenteral nutrition (PN) for 4 or more days per week.
- Trial name
- THRIVE-1 (NCT05011370)
- Where
- 15 sites in United States, Denmark and 2 more
- Volunteers
- 80 people
- Sponsor
- Protara Therapeutics
Advanced Solid Cancers
A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9
The main goal of this study is to evaluate the safety of BNT329 and to identify the best dose of BNT329. This will be done by measuring the number of side effects that participants experience and how severe they are.
- Trial name
- NCT07186842
- Testing
- BNT329, CA19-9-targeting monoclonal antibody
- Where
- 18 sites in United States, Australia and 3 more
- Volunteers
- 245 people
- Sponsor
- BioNTech SE
Primary Biliary Cirrhosis
Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis
prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis (PBC).
- Trial name
- EPICS (NCT03112681)
- Testing
- Saroglitazar magnesium 2 mg, Saroglitazar magnesium 4 mg
- Where
- 9 sites in United States
- Volunteers
- 37 people
- Sponsor
- Zydus Therapeutics Inc.
Minimal Residual Disease, KRAS G12D
A Study of ELI-002 in Subjects With KRAS Mutated Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors
This is a Phase 1 study to assess the safety and efficacy of ELI-002 immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides])…
- Conditions
- Minimal Residual Disease, KRAS G12D, KRAS G12R, NRAS G12D
- Trial name
- AMPLIFY-201 (NCT04853017)
- Testing
- ELI-002 2P
- Where
- 10 sites in United States
- Volunteers
- 25 people
- Sponsor
- Elicio Therapeutics
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
Gastrointestinal Cancer, Prostate Cancer
Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo
The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced disease. The primary evaluation criterion is clinical benefit response.
- Conditions
- Gastrointestinal Cancer, Prostate Cancer, Genital Neoplasms, Female
- Trial name
- NCT00332280
- Testing
- AMT2003
- Where
- 2 sites in Bosnia and Herzegovina, Germany
- Volunteers
- 67 people
- Sponsor
- Auron Healthcare GmbH
Infection
Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance
This study is a post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Ciproxan intravenously as a first-line treatment for sepsis, secondary skin infections…
- Trial name
- NCT01670435
- Testing
- Ciprofloxacin (BAYQ3939)
- Where
- Japan
- Volunteers
- 3,274 people
- Sponsor
- Bayer