Clinical trials: Gastrointestinal Infection
Hepatitis C, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated With PEG-Intron + Ribavirin
This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin.
- Trial name
- NCT00087568
- Testing
- Ribavirin, peginterferon alfa-2a [Pegasys]
- Where
- 25 sites in United States
- Volunteers
- 57 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Chronic
Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)
This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric participants.
- Trial name
- NCT01425190
- Testing
- Boceprevir
- Volunteers
- 16 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C Virus Infection, Human Immunodeficiency Virus Infection
A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection
The primary objectives of this study are to assess the safety of ABT-450/r/ABT-267 with and without ABT-333 coadministered with and without ribavirin (RBV) for 12 and 24 weeks in HCV GT1- or 4-infected participants with HIV-1…
- Conditions
- Hepatitis C Virus Infection, Human Immunodeficiency Virus Infection, Chronic Hepatitis C, Compensated Cirrhosis and Non-cirrhotics
- Trial name
- TURQUOISE-I (NCT01939197)
- Testing
- ABT-450/r/ABT-267, ABT-333, ribavirin
- Volunteers
- 318 people
- Sponsor
- AbbVie
Hepatitis D, Chronic
SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.
This is a phase 2 trial in which participants with chronic hepatitis D virus (HDV) infection will receive VIR-2218 and/or VIR-3434 and be assessed for safety, tolerability, and efficacy
- Trial name
- NCT05461170
- Testing
- VIR-2218, VIR-3434, NRTI
- Where
- 20 sites in Bulgaria, France and 7 more
- Volunteers
- 95 people
- Sponsor
- Vir Biotechnology, Inc.
Hepatitis C, Chronic
APPROACH Study: Quality of Life and Outcomes Assessment in Participants With Chronic Hepatitis C (CHC) Treated With Pegylated Interferon (PEG-IFN) Alfa-2a and Ribavirin
This multi-center, observational study will examine the clinical use and outcomes of pegylated interferon (PEG-IFN) alfa-2a and ribavirin combination (PEGASYS RBV) in participants with chronic hepatitis C (CHC).
- Trial name
- NCT02850289
- Testing
- Pegylated interferon (PEG-INF) alfa-2a, Ribavirin
- Where
- 46 sites in Canada
- Volunteers
- 385 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Chronic
An Observational Study to Assess the Effect of Cumulative Ribavirin Dose in Participants With Chronic Hepatitis C
The purpose of this open-label, non-randomized, single-arm, multicentre observational study is to investigate the influence of the cumulative dose (total administered dose/ planned dose) of ribavirin on the sustained virologic…
- Trial name
- NCT02557646
- Testing
- Peginterferon alfa-2a, Ribavirin
- Where
- 27 sites in Hungary
- Volunteers
- 697 people
- Sponsor
- Hoffmann-La Roche
Hepatitis A
Regulatory Post-Marketing Surveillance Study for Hepatitis A Vaccine (AVAXIM 160U)
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) "Basic standard for reexamination of new drug".
- Trial name
- NCT01838070
- Where
- South Korea
- Volunteers
- 614 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B, Hepatocellular Carcinoma
Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)
Hepatitis B Vaccine [Recombinant] is a well-established vaccine which has been used extensively, worldwide since its initial licensure in 1986.
- Trial name
- NCT00322361
- Testing
- Comparator: RECOMBIVAX HB™, Comparator: Modified process Hepatitis B Vaccine
- Volunteers
- 566 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Peritonitis
Health Economic Assessment of Tygacil® in the Treatment of Secondary Peritonitis in Intensive Care Units (ICUs)
The main goals of the study are: Assessment of Tygacil's cost-effectiveness; Process cost analysis from a hospital perspective (including length of stay, treatment costs, side effect management costs, costs of monitoring, costs…
- Trial name
- NCT00481962
- Testing
- Tygacil
- Where
- Germany
- Volunteers
- 180 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hepatitis B
A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years
This study is conducted to assess safety and immunogenicity of GSK's HBsAg vaccine adjuvanted with GSK's AS37 adjuvant system in healthy, HBs naïve, adults aged 18-45 years and to differentiate GSK's AS37 adjuvant system from…
- Trial name
- NCT05561673
- Testing
- GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide, GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system, GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system
- Where
- 5 sites in Belgium, Germany and 1 more
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatocellular Carcinoma, Hepatitis B
Radomised Phase II Study of MTL-CEBPA Plus Sorafenib or Sorafenib Alone
This is a Phase II study in patients with advanced liver cancer (hepatocellular carcinoma) as a result of hepatitis B and/or C infection.
- Conditions
- Hepatocellular Carcinoma, Hepatitis B, Hepatitis C
- Trial name
- OUTREACH2 (NCT04710641)
- Testing
- MTL-CEBPA, Sorafenib
- Where
- 2 sites in United States, Singapore
- Volunteers
- 8 people
- Sponsor
- Mina Alpha Limited
Diphtheria, Pertussis
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to protection against all…
- Conditions
- Diphtheria, Pertussis, Tetanus, Hepatitis B
- Trial name
- NCT01917357
- Testing
- Quinvaxem in Uniject, Quinvaxem in single dose vials
- Where
- Philippines
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Chronic Hepatitis B
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection
This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-4334 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis…
- Trial name
- NCT06384131
- Testing
- ABI-4334
- Where
- 2 sites in Moldova, New Zealand
- Volunteers
- 20 people
- Sponsor
- Assembly Biosciences
HIV Infection, Hepatitis C Infection
Evaluation of HCV Care and Treatment for HIV-HCV Co-infected Patients in Decentralised Areas in Vietnam
With the advent of direct acting antiviral (DAA) treatment in 2013, HCV elimination has become feasible. Still, achieving HCV elimination in resource-limited countries appears to be arduous as several challenges need to be…
- Trial name
- MOVIDA-Hep2 (NCT05506475)
- Testing
- Blood samples
- Where
- 2 sites in Vietnam
- Volunteers
- 400 people
- Sponsor
- Institut Pasteur
Hepatitis B Vaccines
Lot-to-lot Consistency of Sci-B-Vac™ in Adults
A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults
- Trial name
- NCT03408730
- Testing
- Hepatitis B Vaccination
- Where
- 26 sites in United States, Belgium and 4 more
- Volunteers
- 2,838 people, healthy volunteers welcome
- Sponsor
- VBI Vaccines Inc.
Hepatitis C, Chronic, Hepatitis C
Patient Compliance During PegIntron and Rebetol Combination Therapy in Chronic Hepatitis C (Study P04690)
Participants will receive PegIntron injection pen (Peginterferon alfa-2b) and Rebetol (Ribavirin) combination therapy as their usual medical treatment.
- Trial name
- NCT00725205
- Testing
- PegIntron (Peginterferon alfa-2b), Rebetol (Ribavirin)
- Volunteers
- 294 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Acellular Pertussis, Tetanus
Immunogenicity and Safety of a DTPa-HBV-IPV/Hib Vaccine Given at 2, 3 and 4 Months of Age
The purpose of this study is to show that the immunogenicity of newly formulated DTPa-HBV-IPV/Hib vaccine is as good as the immunogenicity of the currently licensed formulation of the vaccine.
- Conditions
- Acellular Pertussis, Tetanus, Diphtheria, Hepatitis B
- Trial name
- NCT00376779
- Testing
- Infanrix hexa Vaccine
- Where
- 6 sites in Finland
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis C, Chronic
Evaluate the Efficacy and Safety of TG-2349 in Subjects With Hepatitis C Infection
A Phase 2, Multicenter, Randomized, Open-label, Dose-ranging Study to Evaluate the Efficacy and Safety of TG-2349 in Combination with Peg-interferon and Ribavirin in Treatment Naïve East Asian Subjects with Chronic Hepatitis C…
- Trial name
- NCT02340962
- Testing
- TG-2349, Ribavirin, Interferon Alfa-2a
- Where
- Taiwan
- Volunteers
- 25 people
- Sponsor
- TaiGen Biotechnology Co., Ltd.
Hepatitis C
Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 1)
The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.
- Trial name
- NCT01343888
- Testing
- PegIFN/RBV, BI 201335
- Where
- 98 sites in Austria, Belgium and 9 more
- Volunteers
- 656 people
- Sponsor
- Boehringer Ingelheim
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