Clinical trials: Digestive Tract Diseases
Hepatitis B, Diphtheria
Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly
This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV…
- Conditions
- Hepatitis B, Diphtheria, Haemophilus Influenzae Type b (Hib), Poliomyelitis
- Trial name
- NCT01457495
- Testing
- DTPa-HBV-IPV/Hib (Infanrix-hexa™), DTPa-IPV/Hib (Infanrix-IPV/Hib™), HBV (Engerix™-B)
- Volunteers
- 312 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infections
A Comparison of Two Types of Injected Nutritional Supplements in Patients With AIDS and Pneumocystis Carinii Pneumonia (PCP)
The objectives of this study are: To establish whether there is a difference in clinical effectiveness of Liposyn II 20 percent as compared with Liposyn III 2 percent in AIDS patients with Pneumocystis carinii pneumonia (PCP).
- Trial name
- NCT00002275
- Testing
- Fat Emulsion 2%, Fat Emulsion 20%
- Where
- United States
- Sponsor
- Abbott
Cystic Fibrosis
A Study to Confirm the Long-term Safety and Effectiveness of Kalydeco in Patients With Cystic Fibrosis Who Have an R117H-CFTR Mutation, Including Pediatric Patients
The purpose of this study is to confirm the long-term safety and effectiveness of Kalydeco® (ivacaftor) in US CF patients with the R117H-CFTR mutation <18 years of age and to describe the long-term safety and effectiveness of…
- Trial name
- NCT02722057
- Volunteers
- 368 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Solid Tumor
PF-07284892 in Participants With Advanced Solid Tumors
The purpose of this first-in-patient, open label study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lorlatinib, encorafenib and…
- Trial name
- NCT04800822
- Testing
- PF-07284892, lorlatinib, binimetinib
- Where
- 11 sites in United States
- Volunteers
- 53 people
- Sponsor
- Pfizer
Cystic Fibrosis
Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR Mutation
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who have at least one A455E mutation.
- Trial name
- NCT03061331
- Testing
- LUM/IVA
- Where
- 2 sites in Netherlands
- Volunteers
- 20 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small-Cell Lung
Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
This is a phase Ib/II open label study. The escalation part will characterize the safety and tolerability of JDQ443 single agent and JDQ443 in combination with the other study treatments (TNO155 and tislelizumab) in advanced…
- Conditions
- KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small-Cell Lung, Carcinoma, Colorectal, Cancer of Lung
- Trial name
- KontRASt-01 (NCT04699188)
- Testing
- JDQ443, TNO155, tislelizumab
- Where
- 38 sites in United States, Australia and 14 more
- Volunteers
- 344 people
- Sponsor
- Novartis Pharmaceuticals
Cystic Fibrosis
Extension Study of Ataluren in Participants With Nonsense Mutation Cystic Fibrosis
This is an open-label extension study for participants who completed a Phase 3, placebo-controlled study of ataluren in participants with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.
- Trial name
- NCT02456103
- Testing
- Ataluren
- Where
- 70 sites in United States, Argentina and 14 more
- Volunteers
- 246 people
- Sponsor
- PTC Therapeutics
Hepatitis B, Chronic (CHB)
PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (P04498/MK-4031-278)
This is an open label, randomized, comparative, multi-center study. Subjects will be screened within 2 weeks prior to study entry to establish eligibility.
- Trial name
- NCT00371761
- Testing
- Pegylated interferon alfa-2b (PegIntron), Adefovir dipivoxil (adefovir)
- Volunteers
- 25 people
- Sponsor
- Merck Sharp & Dohme LLC
Primary Biliary Cholangitis (PBC)
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver). PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a…
- Trial name
- ELFIDENCE (NCT06016842)
- Testing
- Elafibranor
- Where
- 198 sites in United States, Argentina and 26 more
- Volunteers
- 276 people
- Sponsor
- Ipsen
Diphtheria, Pertussis
Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®
PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by H.
- Conditions
- Diphtheria, Pertussis, Polio, Hepatitis B
- Trial name
- NCT00362427
- Testing
- Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
- Where
- 8 sites in Canada
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Advanced or Metastatic Solid Tumors
Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors
This is a first-in-human, open-label, multicenter, Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of IPH4502 and to determine the recommended Phase 2 dose (RP2D) in advanced solid tumors that are…
- Trial name
- NCT06781983
- Testing
- IPH4502
- Where
- 7 sites in United States, France
- Volunteers
- 145 people
- Sponsor
- Innate Pharma
Cancer
RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma
RATIONALE: Monoclonal antibodies, such as RAV12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread.
- Trial name
- NCT00101972
- Testing
- monoclonal antibody RAV12
- Where
- 5 sites in United States
- Volunteers
- 53 people
- Sponsor
- MacroGenics
Gall Bladder Disease, Bile Duct Diseases
AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study
This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips.
- Conditions
- Gall Bladder Disease, Bile Duct Diseases, Acute Cholecystitis, Kidney
- Trial name
- AE05ML (NCT06364865)
- Testing
- laparoscopic procedure
- Where
- 3 sites in United States
- Volunteers
- 161 people
- Sponsor
- Teleflex
Cystic Fibrosis
PK Study of N91115 in Cystic Fibrosis Patients
This Phase 1 study in F508del-CFTR homozygous CF patients is being conducted to assess the pharmacokinetics and absorption dynamics of N91115 compared with healthy subjects in order to identify an initial starting dose for Phase…
- Trial name
- SNO3 (NCT02227888)
- Testing
- N91115
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Nivalis Therapeutics, Inc.
Astrocytoma, Brain Cancer
Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S
This is a multi-center, open-label, dose escalation study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and maximum tolerated dose (MTD) of QBS10072S in patients with advanced or metastatic cancers…
- Conditions
- Astrocytoma, Brain Cancer, Brain Metastases, Bladder Cancer
- Trial name
- NCT04430842
- Testing
- QBS10072S
- Where
- 2 sites in Australia
- Volunteers
- 15 people
- Sponsor
- Quadriga Biosciences, Inc.
Pneumonia, Lung Abscess
Special Use-Result Surveillance of Unasyn-S (Kit) for Intravenous Use - A Surveillance on High-dose (>6 g Daily) Administration -
The purpose of the survey is to study the followings under practical use, regarding the safety and effectiveness in high-dose administration (exceeding 6 g per day) of UNASYN-S and UNASYN-S KIT for intravenous use (UNASYN). 1.
- Conditions
- Pneumonia, Lung Abscess, Peritonitis
- Trial name
- NCT01793688
- Testing
- Sulbactam Sodium/Ampicillin Sodium
- Volunteers
- 982 people
- Sponsor
- Pfizer
Non-small Cell Lung Cancer, Head and Neck Cancer
A First-in-Human Study of JAB-3068 (SHP2 Inhibitor) in Adult Patients With Advanced Solid Tumors in China
This is a Phase 1/2a, open-label, multi-center study of JAB-3068 in Patients with advanced solid tumors.This study has two phases: dose escalation phase and dose expansion phase.
- Conditions
- Non-small Cell Lung Cancer, Head and Neck Cancer, Esophageal Cancer, Other Metastatic Solid Tumors
- Trial name
- NCT03565003
- Testing
- JAB-3068
- Where
- 4 sites in China
- Volunteers
- 126 people
- Sponsor
- Jacobio Pharmaceuticals Co., Ltd.
Non-small Cell Lung Cancer, Pancreatic Cancer
Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia
Study to compare the effects of the investigational new drug (PF-06946860) and a placebo on appetite and to find out how participants with advanced cancer and anorexia feel after receiving repeated subcutaneous (SC-injected under…
- Conditions
- Non-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Prostate Cancer
- Trial name
- NCT04803305
- Testing
- PF-06946860
- Where
- 33 sites in United States, Canada
- Volunteers
- 18 people
- Sponsor
- Pfizer
Cystic Fibrosis
Single Dose Escalation Study of TR02 (Sustained Lipid Inhalation Technology [SLIT™] Amikacin) in Participants With Cystic Fibrosis (CF) Having Chronic Infections of Pseudomonas Aeruginosa
The primary purpose of this study is to evaluate the safety and tolerability of three active doses of nebulized amikacin in a SLIT™ formulation.
- Trial name
- NCT06238856
- Testing
- SLIT™ Amikacin
- Volunteers
- 18 people
- Sponsor
- Insmed Incorporated
Cystic Fibrosis
Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis
This is a phase 1b multiple ascending dose escalation study to evaluate the safety and tolerability of arginase inhibitor CB-280 in subjects with cystic fibrosis.
- Trial name
- NCT04279769
- Testing
- CB-280
- Where
- 20 sites in United States, Canada
- Volunteers
- 32 people
- Sponsor
- Calithera Biosciences, Inc
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