Clinical trials: Gastrointestinal Infections
Hepatitis C
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules.
- Trial name
- NCT01591668
- Testing
- Single Ascending Dose Cohorts GS-9620, Multiple Ascending Dose Cohorts GS-9620
- Where
- 11 sites in United States, Puerto Rico
- Volunteers
- 51 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus
TMC435-TiDP16-C125 - Study in Healthy Volunteers to Evaluate the Potential of TMC435 to Increase the Sensitivity of the Skin Towards Exposure to Sun Light
The purpose of the study is to evaluate the potential effect of TMC435 on the sensitivity of the skin towards exposure to sunlight.
- Trial name
- NCT01124799
- Testing
- TMC435, Ciprofloxacin
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Genital Warts, Anal Cancer
Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)
This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV vaccine, V503) in 16- to 26-year old men and women.
- Conditions
- Genital Warts, Anal Cancer, Anal Intraepithelial Neoplasia
- Trial name
- NCT01651949
- Testing
- 9vHPV Vaccine
- Volunteers
- 2,520 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis C
Multiple Dose Study In Treatment Naive Subjects Infected With Hepatitis C Virus
The purpose of this study is to determine the antiviral effect following three days of dosing with BMS-824393 in chronically genotype subtype 1a and 1b Hepatitis C virus (HCV) infected subjects.
- Trial name
- NCT00971308
- Testing
- BMS-824393
- Where
- 6 sites in United States
- Volunteers
- 37 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C
Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in HCV Genotype 1 or 4 Patients Resistant to Bitherapy Alone
This study is designed to evaluate the safety of biological active dose of a new experimental drug, IL-7, in combination with standard bi-therapy in patients with Hepatitis C chronic infection identified as non responders to the…
- Trial name
- Eclipse 2 (NCT01025297)
- Testing
- Interleukin-7
- Where
- 8 sites in France, Italy and 1 more
- Volunteers
- 18 people
- Sponsor
- Cytheris SA
Diphtheria, Tetanus
DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants
The aim of this study is to evaluate the immunogenicity and safety of a novel DTaP-IPV-Hep B-PRP~T fully liquid combined hexavalent vaccine (study vaccine) administered at 2, 4, and 6 months of age compared to Sanofi Pasteur's…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b Infection
- Trial name
- NCT02094833
- Testing
- DTaP-IPV-Hep B-PRP~T combined vaccine, DTaP-IPV//PRP~T and Hepatitis B vaccine
- Where
- 16 sites in South Korea
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B
Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years old.
- Trial name
- NCT00435812
- Testing
- Engerix-B
- Where
- 18 sites in Canada, Germany
- Volunteers
- 2,428 people, healthy volunteers welcome
- Sponsor
- Dynavax Technologies Corporation
Hepatitis C, Chronic
Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)(TERMINATED)
This is a Phase IIIB randomized, controlled, multi-centre, open-label study of 24 versus 48 weeks therapy with Pegetron® (peginterferon alfa-2b + ribavirin) at standard doses in naïve Hepatitis C Virus (HCV) genotype 1 high viral…
- Trial name
- NCT00423800
- Testing
- Combination of pegylated interferon alfa-2b (PEG) and ribavirin (RBV)
- Volunteers
- 56 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis B
Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System
This study aims to develop innovative immunological read-outs and new technologies in order to further characterise the early immune response and its kinetics as well as the adaptive immune responses to adjuvanted vaccines.
- Trial name
- NCT01777295
- Testing
- Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A., EngerixTM-B
- Where
- Belgium
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis C
Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care
The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24…
- Trial name
- NCT01359644
- Testing
- PSI-7977, Daclatasvir, Ribavirin
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 350 people
- Sponsor
- Bristol-Myers Squibb
MRSA, Cystic Fibrosis
AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis
This is a multi-center, randomized phase III study to evaluate the clinical effectiveness of AeroVanc in persistent methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis (CF).
- Trial name
- NCT03181932
- Testing
- Vancomycin inhalation powder
- Where
- 71 sites in United States, Canada
- Volunteers
- 188 people
- Sponsor
- Savara Inc.
Hepatitis C Virus
Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India
This study will evaluate the safety and efficacy of sofosbuvir (SOF)-based regimens administered as per the approved prescribing information in adults with chronic hepatitis C virus (HCV) infection treated in routine clinical…
- Trial name
- NCT02592057
- Testing
- SOF
- Where
- 26 sites in India
- Volunteers
- 532 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus
Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus
The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to…
- Trial name
- NCT01628692
- Testing
- Daclatasvir, Simeprevir, Ribavirin
- Where
- 26 sites in United States, Argentina and 4 more
- Volunteers
- 230 people
- Sponsor
- Bristol-Myers Squibb
Non-alcoholic Steatohepatitis, Chronic Liver Disease
Eltrombopag To Reduce The Need For Platelet Transfusion In Subjects With Chronic Liver Disease And Thrombocytopenia Undergoing Elective Invasive Procedures
The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive…
- Conditions
- Non-alcoholic Steatohepatitis, Chronic Liver Disease, HCV, NASH - Nonalcoholic Steatohepatitis
- Trial name
- ELEVATE (NCT00678587)
- Testing
- Eltrombopag
- Where
- 107 sites in United States, Argentina and 11 more
- Volunteers
- 292 people
- Sponsor
- GlaxoSmithKline
Hepatitis B Virus
A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting
A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan.
- Trial name
- NCT03083821
- Testing
- Baraclude
- Where
- Japan
- Volunteers
- 6 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C, Chronic
Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs
The purposes of this Phase 1/2 study are to examine the safety, tolerability, and antiviral activity of ISIS 14803, when given in combination with peginterferon alfa and ribavirin, to patients who either failed to have at least a…
- Trial name
- NCT00062816
- Testing
- ISIS 14803, peginterferon alfa, ribavirin
- Where
- 25 sites in United States
- Volunteers
- 22 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Hepatitis C, Hepatitis
Merimepodib (MMPD) in Triple Combination for the Treatment of Chronic Hepatitis C
This trial is designed to test whether or not the addition of merimepodib (MMPD) to the standard therapy of pegylated interferon and ribavirin will result in a positive treatment response for people who have not previously…
- Trial name
- NCT00088504
- Testing
- Merimepodib, PEG-Interferon-alpha 2a (Pegasys®), Ribavirin (Copegus®)
- Where
- 67 sites in United States
- Volunteers
- 315 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Growth, Tolerance
Human Milk Oligosaccharides (HMOs) Post-market Study on Infants
Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT).
- Conditions
- Growth, Tolerance, Adverse Event, Disorder of Intestine
- Trial name
- NEHMO (NCT04055363)
- Testing
- HMO-supplemented infant formula
- Where
- 6 sites in Spain
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
HCV Infection
Safety, Tolerability and PK Study of Single Doses of ABT-450 With and Without Ritonavir to Treat Hepatitis C Virus (HCV) Genotype 1
The purpose of this study is to determine the pharmacokinetic and safety profiles of an experimental HCV protease inhibitor with and without ritonavir in healthy volunteers.
- Trial name
- NCT00850044
- Testing
- ABT-450, ritonavir
- Where
- United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- AbbVie
Virus Diseases, Hepatitis B
Study of the Immunogenicity and Safety of a Challenge Dose of HBVAXPRO in Healthy Children Vaccinated 10 Years Ago With 3 Doses of HEXAVAC or INFANRIX HEXA
To evaluate the immune response to Hepatitis B virus in children who have been primed with HEXAVAC or INFANRIX HEXA 10 years ago.
- Trial name
- NCT02012998
- Testing
- HBVAXPRO 5µg
- Where
- 10 sites in Italy
- Volunteers
- 751 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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