Clinical trials: Gastrointestinal Infections
Chronic Hepatitis C
Trial of MitoQ for Raised Liver Enzymes Due to Hepatitis C
A Phase 2, randomized, double-blind, parallel design trial of two doses of mitoquinone mesylate (MitoQ) and of placebo in patients with chronic Hepatitis C.
- Trial name
- NCT00433108
- Testing
- Mitoquinone mesylate (MitoQ)
- Where
- 2 sites in New Zealand
- Volunteers
- 30 people
- Sponsor
- Antipodean Pharmaceuticals, Inc.
Haemophilus Influenzae Type b, Tetanus
A Study to Assess Antibody Persistence, Boostability & Safety in Previously Primed Subjects.
The purpose of the study is as follows: To evaluate the persistence of antibodies and the presence of immune memory induced by a 3-dose primary vaccination with Tritanrix™-HepB/Hib-MenAC (three formulations) in the study…
- Conditions
- Haemophilus Influenzae Type b, Tetanus, Whole Cell Pertussis, Hepatitis B
- Trial name
- NCT00317174
- Testing
- DTPw-HBV/Hib-MenAC conjugate vaccine
- Where
- Philippines
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis, Burkholderia Infection
A Study of OligoG in Cystic Fibrosis Subjects With Burkholderia Spp. Infection
The purpose of the study is to assess the efficacy of Alginate oligosaccharide (OligoG) dry powder for inhalation in cystic fibrosis (CF) patients with a Burkholderia spp. infection.
- Trial name
- SMR-2591 (NCT02453789)
- Testing
- Alginate oligosaccharide
- Where
- 2 sites in Germany
- Volunteers
- 15 people
- Sponsor
- AlgiPharma AS
Hepatitis C, Liver Cirrhosis
Open Label Single Dose Phase I Trial of BI 201335 to Study Pharmacokinetics and Safety in Patients With Compensated Liver Cirrhosis
This trial was intended to investigate the pharmacokinetics, safety and tolerability of BI 201335 NA soft-gel capsules in patients with compensated liver cirrhosis, i.e. grade A according to Child-Pugh classification (< 7 points).
- Trial name
- NCT01909778
- Testing
- BI 201335
- Where
- Germany
- Volunteers
- 2 people
- Sponsor
- Boehringer Ingelheim
Advanced Solid Tumors, Genital Neoplasm, Female
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent and in combination with chemotherapy administered intravenously in participants…
- Conditions
- Advanced Solid Tumors, Genital Neoplasm, Female, Urogenital Neoplasms, Lung Neoplasm
- Trial name
- START-001 (NCT05592626)
- Testing
- STAR0602, Irinotecan (Camptosar), Docetaxel (Taxotere)
- Where
- 19 sites in United States, Canada and 2 more
- Volunteers
- 366 people
- Sponsor
- Marengo Therapeutics, Inc.
Hepatitis C, Chronic
SH229 Tablets Combined With Daclatasvir Dihydrochloride Tablets in Treatment Adult Patients With Chronic Hepatitis C
Phase II: Exploring the efficacy and safety of different doses of SH229 tablets combined with fixed-dose Daclatasvi dihydrochloride (DCV) tablets in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing…
- Trial name
- NCT04070235
- Testing
- SH229 tablets, Daclatasvir dihydrochloride
- Where
- China
- Volunteers
- 440 people
- Sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
Hepatitis E
Safety and Immunogenicity Study of Thiomersal-free Hepatitis E Vaccine in People Ages 16 Years and Above
The purpose of this study is to evaluate the safety and non-inferior immunogenicity of thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli) compared with licensed Recombinant Hepatitis E Vaccine (Escherichia Coli)…
- Trial name
- NCT06564116
- Testing
- Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli), Recombinant Hepatitis E Vaccine (Escherichia Coli)
- Where
- China
- Volunteers
- 612 people, healthy volunteers welcome
- Sponsor
- Xiamen Innovax Biotech Co., Ltd
Hepatitis B
Neonatal Vaccination Against Hepatitis B in Africa - Sero-survey in Senegal
Chronic infection with hepatitis B virus (HBV) is a leading cause of death in adults in sub-Saharan Africa (SSA). Prior to the introduction of the hepatitis B vaccine, main modes of transmission in SSA were perinatal transmission…
- Trial name
- NeoVac2S (NCT03829735)
- Testing
- Human biological samples
- Volunteers
- healthy volunteers welcome
- Sponsor
- Institut Pasteur
Chronic Hepatitis C Virus, Hepatitis C Virus
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus Infection
The purpose of this phase 3 study is to evaluate the efficacy and safety of ABT-493/ABT-530 in comparison to sofosbuvir plus ribavirin for 12 weeks in Hepatitis C Virus (HCV) Genotype 2 (GT2) infected participants.
- Trial name
- CERTAIN-2 (NCT02723084)
- Testing
- ABT-493/ABT-530, sofosbuvir (SOF), ribavirin (RBV)
- Volunteers
- 136 people
- Sponsor
- AbbVie
Hepatitis B, Poliomyelitis
Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination Course
The study will compare the immunogenicity and the reactogenicity of INFANRIX™ HEXA and HEXAVAC™ vaccines in a 3, 5 and 11 - 12 month vaccination schedule.
- Conditions
- Hepatitis B, Poliomyelitis, Diphtheria, Acellular Pertussis
- Trial name
- NCT01457547
- Testing
- DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA), DTPa-HBV-IPV-Hib vaccine (HEXAVAC™)
- Where
- 9 sites in Finland, Italy and 1 more
- Volunteers
- 494 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Epstein-Barr Virus Associated Lymphoma, EBV-Positive DLBCL, NOS
An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas
A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas
- Conditions
- Epstein-Barr Virus Associated Lymphoma, EBV-Positive DLBCL, NOS, EBV-Related Non-Hodgkin Lymphoma, EBV Related PTCL, NOS
- Trial name
- NAVAL-1 (NCT05011058)
- Testing
- Nanatinostat in combination with valganciclovir
- Where
- 62 sites in United States, Australia and 12 more
- Volunteers
- 102 people
- Sponsor
- Viracta Therapeutics, Inc.
Hepatitis C, Chronic
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.
This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC…
- Trial name
- NCT00377182
- Testing
- Copegus, PEGASYS, RO5024048 1500mg
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 107 people
- Sponsor
- Hoffmann-La Roche
HCV Infection
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
multicenter prospective study to evaluate the clinical performance, usability and contrived result interpretation of the INSTI® HCV Antibody Test (INSTI HCV) with fingerstick (FS) whole blood specimens from participants with…
- Trial name
- NCT07904416
- Testing
- INSTI HCV Antibody Test
- Volunteers
- 388 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Hepatitis C Virus Infection
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and SOF/VEL FDC and ribavirin (RBV) for 12 weeks in participants with…
- Trial name
- NCT02781558
- Testing
- SOF/VEL, RBV
- Where
- 28 sites in Spain
- Volunteers
- 204 people
- Sponsor
- Gilead Sciences
Diphtheria, Tetanus
Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722) and booster vaccination in Study A3L27 (NCT01444781).
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01983540
- Testing
- DTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccine, DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccine, Infanrix hexa + Prevenar + Rotarix vaccine
- Where
- 2 sites in Colombia, Costa Rica
- Volunteers
- 558 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis C
Virology Follow up Study in Subjects Previously Treated With Telaprevir
Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time.
- Trial name
- NCT00916474
- Testing
- telaprevir
- Where
- 41 sites in United States, Canada and 3 more
- Volunteers
- 408 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Hepatitis B, Chronic
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues
This observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) analogues.
- Trial name
- NCT01794234
- Where
- 9 sites in Poland
- Volunteers
- 44 people
- Sponsor
- Hoffmann-La Roche
Cystic Fibrosis
A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
This is a 48-week extension study to CMA-0631-PR-0010 Core Study. Patients who have a positive culture for P. aeruginosa at visit 4 of the first 8-week core study period and/or if deemed appropriate by the Investigators will be…
- Trial name
- CT03Ext (NCT01111383)
- Testing
- tobramycin
- Where
- 20 sites in France, Poland and 1 more
- Volunteers
- 209 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Hepatitis C, Chronic
A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment
The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants…
- Trial name
- NCT00703118
- Testing
- Telaprevir, Peg-IFN-alfa-2a, Ribavirin
- Where
- 91 sites in United States, Australia and 14 more
- Volunteers
- 663 people
- Sponsor
- Tibotec BVBA
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection
The primary objective of the PK Lead-in Phase of the study is to evaluate the steady state pharmacokinetics (PK) and confirm the dose of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis C virus…
- Trial name
- NCT02249182
- Testing
- LDV/SOF, RBV
- Where
- 31 sites in United States, Australia and 2 more
- Volunteers
- 226 people
- Sponsor
- Gilead Sciences
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