Clinical trials: Digestive Infection
Hepatitis B, Chronic
Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B
The REP 201 protocol is a small exploratory study assessing the antiviral effects and tolerability of REP 2139-Ca when used with a full course of pegylated interferon (48 weeks) in treatment naive patients or in patients already…
- Trial name
- NCT02726789
- Testing
- REP 2139-Ca, pegylated interferon, entecavir
- Volunteers
- 5 people
- Sponsor
- Replicor Inc.
Human Immunodeficiency Virus, Hepatitis C
Computer-based Intervention for Alcohol-using HIV/HCV+ Women
The study harnessed the multidisciplinary expertise of our research team to develop a brief, computer-based, alcohol reduction intervention tailored for HIV/HCV co-infected women and evaluate its efficacy.
- Conditions
- Human Immunodeficiency Virus, Hepatitis C, Alcohol Abuse
- Trial name
- NCT03362476
- Testing
- Computer-based alcohol reduction intervention, Brief clinician-delivered MET, Standard of care
- Where
- 2 sites in United States, Russia
- Volunteers
- 200 people
- Sponsor
- New York University
Hepatitis B
First-In-Human Study of ChAdOx1-HBV & MVA-HBV Vaccines (VTP-300) for Chronic HBV
This is an open-label study to determine the safety, tolerability and immunogenicity of ChAdOx1-HBV and MVA-HBV vaccines, with or without nivolumab, in patients with chronic HBV who are virally suppressed with oral anti-viral…
- Trial name
- NCT04778904
- Testing
- ChAdOx1-HBV, MVA-HBV, Nivolumab
- Where
- 12 sites in South Korea, Taiwan and 1 more
- Volunteers
- 55 people
- Sponsor
- Barinthus Biotherapeutics
Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation
Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients
There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered antibiotic pharmacokinetics compared with non-CF patients.
- Conditions
- Cystic Fibrosis, Cystic Fibrosis Pulmonary Exacerbation, Pseudomonas Aeruginosa Infection
- Trial name
- NCT02421120
- Testing
- Ceftolozane/Tazobactam
- Where
- 4 sites in United States
- Volunteers
- 21 people
- Sponsor
- Joseph L. Kuti, PharmD
Diphtheria, Tetanus
A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered as a Three-dose Vaccination Course at 3, 4.5 and 6 Months of Age and a Booster Dose at 18 Months of Age in Healthy Infants in Russia
The purpose of this study is to evaluate the immune response, safety and reactogenicity after receiving combined DTPa-IPV/Hib vaccine when administered as a three-dose primary vaccination course at 3, 4.5 and 6 months of age and…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT02858440
- Testing
- Infanrix-IPV/Hib
- Where
- 5 sites in Russia
- Volunteers
- 235 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV, Hepatitis C
Pioglitazone to Treat Fatty Liver in Patients With HIV and Hepatitis C Infections
This study will evaluate the effectiveness of pioglitazone in reducing liver fat content in patients with HIV and hepatitis C virus (HCV) infections.
- Conditions
- HIV, Hepatitis C, Liver Disease, Fatty Liver
- Trial name
- NCT00742326
- Testing
- Pioglitazone
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hepatitis C, Chronic Hepatitis C
Impact of Patient Support by the Medical Staff on Adherence to Therapy With PegIntron Plus Rebetol (Study P04413)
The objective of this study is to assess the impact of participant care and support on treatment adherence. PegIntron pen and Rebetol will be administered to participants with Hepatitis C Virus (HCV) in accordance with approved…
- Trial name
- @dhere (NCT00704964)
- Testing
- PegIntron, Rebetol
- Volunteers
- 746 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C
MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED)
A Study to assess the general safety and tolerability of the administration of a 3-dose prime/boost regimen of the MRKAd5 HIV-1 gag vaccine (V520) in subjects with chronic hepatitis C virus infection.
- Trial name
- NCT00857311
- Testing
- MRKAd5 HIV-1 gag vaccine (V520), Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed
- Volunteers
- 17 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
Safety and Efficacy of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 (Study P05216AM2) (COMPLETED)
This study involves treatment with boceprevir or placebo in combination with PegIntron (PEG) + Ribavirin (RBV) (weight-based dosing [WBD]) in previously untreated adult participants with chronic hepatitis C (CHC) genotype 1.
- Trial name
- SPRINT-2 (NCT00705432)
- Testing
- Peginterferon alfa-2b (PEG), Ribavirin (RBV), Boceprevir
- Volunteers
- 1,472 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, HIV
Open Label Study to Evaluate Chronic Hepatitis C Treatment in Latino Subjects With and Without HIV Co-infection
Peginterferon alfa-2a has been approved by the U.S. Food and Drug Administration (FDA) to treat adults with chronic hepatitis C virus (HCV) infection with liver disease who have not been previously treated with interferon-alpha…
- Trial name
- LATHCV (NCT01182298)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Enterocolitis, Necrotizing, Bacteremia
Antibiotic "Dysbiosis" in Preterm Infants
Prolonged antibiotic use in preterm neonates has significant consequences on the developing intestinal microbiome, metabolome and host response, predisposing the neonate to various major morbidities, including necrotizing…
- Conditions
- Enterocolitis, Necrotizing, Bacteremia, Bronchopulmonary Dysplasia, Intraventricular Hemorrhage
- Trial name
- NCT02784821
- Testing
- Antibiotic, Gastric fluid, Breast milk
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- University of Florida
Hepatitis C, Chronic
The Effects of PegIntron Plus Rebetol in Subjects With Chronic Hepatitis C Not Responding to Pegasys (Study P03833)
This is an uncontrolled, non-randomized, open-label, multinational study designed to evaluate the efficacy and safety of PegIntron plus Rebetol in subjects with chronic hepatitis C.
- Trial name
- NCT00441584
- Testing
- PegIntron (peginterferon alfa-2b), Rebetol (ribavirin)
- Volunteers
- 117 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Cryoglobulinemia
Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia
10 patients with chronic genotype 1 HCV infection and mixed cryoglobulinemia will be treated with Ledipasvir/Sofosbuvir 90mg/400 mg FDC once daily for 12 weeks (naïve subjects or non-cirrhotic treatment experienced subjects) or…
- Trial name
- NCT02825212
- Testing
- Harvoni, Epclusa
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Hepatitis C
Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual
Patients with chronic hepatitis genotype 1b, who are intolerant or ineligible to Interferon alfa therapy with or without Ribavirin, will be treated for 24 weeks with Daclatasvir (DCV) Dual regimen (= Daclatasvir + Asunaprevir)…
- Trial name
- NCT01995266
- Testing
- Asunaprevir, Daclatasvir
- Where
- 38 sites in China, South Korea and 1 more
- Volunteers
- 218 people
- Sponsor
- Bristol-Myers Squibb
Appendicitis
Wound Infection Alexis Wound Retractor
The purpose of this study is to determine whether the incidence of surgical site wound infection will be reduced in open appendectomy patients through the use of the Alexis® wound retractor.
- Trial name
- NCT00323453
- Testing
- Open appendectomy using Alexis Wound Retractor followed by standardized wound closure, Open appendectomy with standardized wound closure
- Where
- United States
- Volunteers
- 109 people
- Sponsor
- Santa Barbara Cottage Hospital
Hepatitis C, Chronic
An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease
The purpose of this study is to assess the efficacy of a 12-week regimen containing simeprevir, daclatasvir and sofosbuvir in participants with decompensated liver disease (the liver function is insufficient) due to genotype 1 or…
- Trial name
- NCT02262728
- Testing
- Simeprevir, Daclatasvir, Sofosbuvir
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Janssen Research & Development, LLC
Inflammatory Bowel Diseases, Clostridium Difficile Infection
ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI
This is a randomized controlled trial to assess the clinical and microbiological impacts of FMT in combination with Bezlotoxumab (bezlo) compared to FMT in combination with placebo in patients with both inflammatory bowel disease…
- Trial name
- ICON-2 (NCT03829475)
- Testing
- Bezlotoxumab, Fecal Microbiota Transplantation
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Brigham and Women's Hospital
Clostridium Infections, Diarrhea
PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- NCT00468728
- Testing
- PAR-101/OPT-80, Vancomycin
- Where
- 116 sites in United States, Belgium and 7 more
- Volunteers
- 535 people
- Sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Hepatitis C
Pre-Transplant Treatment to Prevent Recurrence of Hepatitis C After Liver Transplantation
The purpose of this study is to learn if pre-liver transplant treatment, using peginterferon plus ribavirin, will clear hepatitis C virus (HCV) RNA from the blood in HCV-infected recipients and reduce the risk of recurrent HCV…
- Trial name
- LADR (NCT00135798)
- Testing
- LADR Treatment
- Where
- 8 sites in United States
- Volunteers
- 79 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Japanese Encephalitis, Hepatitis A
Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children
Safety: To describe the safety profiles following vaccination. Immunogenicity: To describe the immune response after a single dose of vaccine.
- Trial name
- NCT00621764
- Testing
- Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28), Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)
- Where
- 3 sites in Thailand
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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