Clinical trials: Gastrointestinal Infection
Hepatitis C Virus
Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients
To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than…
- Trial name
- HEPCAT (NCT01125189)
- Testing
- Daclatasvir, peg-interferon alfa-2a, ribavirin
- Where
- 64 sites in United States, Australia and 9 more
- Volunteers
- 558 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis C Genotype 1b
Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Daclatasvir in Treatment-Naїve Patients With Chronic Hepatitis C Genotype 1b
The purpose of this study is to confirm that combination of Narlaprevir, Ritonavir and Daclatasvir is safe and highly effective regimen in treatment-naїve patients with chronic hepatitis C (HCV) genotype 1b infection.
- Trial name
- NCT03485846
- Testing
- Narlaprevir, Ritonavir, Daclatasvir
- Where
- 4 sites in Russia
- Volunteers
- 105 people
- Sponsor
- R-Pharm
HIV Infection, Hepatitis C
A Study Exploring an Induction-Maintenance Kaletra-Based Therapy Versus a Sustiva-Based Regimen in Previously Non-Treated, HIV-1/HCV Co-Infected Subjects
The purpose of this study is to determine whether a simplified lopinavir/ritonavir-based therapy will continue to keep the viral load at very low levels after initial treatment with a combination of Kaletra (lopinavir/ritonavir)…
- Trial name
- NCT00121017
- Testing
- Kaletra (lopinavir/ritonavir), Sustiva (efavirenz), Truvada (emtricitabine/tenofovir disoproxil fumarate)
- Volunteers
- 200 people
- Sponsor
- Abbott
Hepatitis B Virus
Dose Ranging Study of Pegylated Interferon Lambda in Patients With Hepatitis B and Positive for the Hepatitis B e Antigen
At least 1 dose of pegIFNλ will be identified which is safe, well tolerated, and efficacious for the treatment of chronic hepatitis B virus infection (CHB) Amendment 7, Part B Sub Study: The primary purpose of this amendment is…
- Trial name
- LIRA-B (NCT01204762)
- Testing
- pegIFN, pegIFNα-2a, PegIFN lambda
- Where
- 53 sites in United States, Australia and 9 more
- Volunteers
- 197 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B
Bioequivalence of LB80380 Free Base and Maleate Salt Tablets
The study is to compare pharmacokinetics of LB80331 and LB80317, which are the metabolites of LB80380, after a single oral administration of LB80380 free base 150 mg (60 mg + 90 mg) tablet or LB80380 maleate tablet 183 mg (150 mg…
- Trial name
- NCT01427868
- Testing
- LB80380 maleate salt, LB80380 free base
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Hepatitis B
Acceptability of Hepatitis B Vaccination in General Practitioners and Paediatricians
The present study is conducted in order to assess the acceptability of Hepatitis B vaccination in French general practitioners and peadiatricians before and after reimbursement of the paediatric vaccine InfanrixHexa.
- Trial name
- PRALINE (NCT01777074)
- Testing
- Data collection
- Where
- 402 sites in France
- Volunteers
- 474 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
Safety and Efficacy Study of Clevudine Compared With Clevudine and Vaccine in Patient With HBeAg(+) Chronic HBV
A randomized, parallel, multicenter, active-controlled with 48 weeks of treatment period. Patients will be randomized to receive clevudine alone for 48 weeks or clevudine for 24 weeks followed by 24 weeks of clevudine in addition…
- Trial name
- NCT00501124
- Testing
- Clevudine, Purified hepatitis B surface antigen
- Where
- 7 sites in South Korea
- Volunteers
- 70 people
- Sponsor
- Bukwang Pharmaceutical
Abscess, Intra-Abdominal, Abdominal Abscess
A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections
The purpose of the study is to evaluate the safety and tolerability of doripenem compared with meropenem in children hospitalized with complicated intra-abdominal infections.
- Conditions
- Abscess, Intra-Abdominal, Abdominal Abscess, Abdomen, Acute, Abdominal Pain
- Trial name
- NCT01110382
- Testing
- Doripenem, Meropenem, Amoxicillin/clavulanate potassium
- Where
- 19 sites in United States, Argentina and 6 more
- Volunteers
- 41 people
- Sponsor
- Janssen Research & Development, LLC
Dysentery, Dysentery, Bacillary
Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old
The purpose of this study is to evaluate immunogenicity and safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old.
- Trial name
- NCT04865497
- Testing
- S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine, Haemophilus b Conjugate Vaccine
- Where
- China
- Volunteers
- 1,050 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Infections, Intestinal
GSK2251052 in the Treatment of Complicated Intra-abdominal Infections
This study is being conducted to evaluate the safety, efficacy and pharmacokinetics/pharmacodynamics of GSK2251052 in subjects with complicated intra abdominal infections.
- Trial name
- NCT01381562
- Testing
- Drug: GSK2251052, Meropenem
- Where
- 31 sites in United States, Canada and 5 more
- Volunteers
- 15 people
- Sponsor
- GlaxoSmithKline
B-cell Acute Lymphoblastic Leukemia, Lymphoma
Autologous CAR-T/TCR-T Cell Immunotherapy for Malignancies
This is a single arm, open-label, uni-center, phase I-II study to evaluate the safety and effectiveness of CAR-T/TCR-T cell immunotherapy in treating with different malignancies patients.
- Conditions
- B-cell Acute Lymphoblastic Leukemia, Lymphoma, Myeloid Leukemia, Multiple Myeloma
- Trial name
- NCT03638206
- Testing
- CAR-T cell immunotherapy
- Where
- China
- Volunteers
- 73 people
- Sponsor
- Shenzhen BinDeBio Ltd.
Hepatitis C Virus
A Study in Healthy Female Participants Investigating the Effect of TMC435 on the Pharmacokinetics of the Synthetic Hormones of the Oral Contraceptive Ovysmen
The purpose of this study is to investigate the effect of steady-state concentrations of TMC435 (administered once a day) on the steady-state pharmacokinetics of ethinylestradiol and norethindrone (administered once a day) and on…
- Trial name
- NCT01486004
- Testing
- TMC435, Ovysmen
- Where
- Belgium
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Hepatitis C
Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy
An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan
- Trial name
- NCT03071133
- Where
- Japan
- Volunteers
- 344 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C Virus Infection
Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with…
- Trial name
- POLARIS-3 (NCT02639338)
- Testing
- SOF/VEL/VOX, SOF/VEL
- Where
- 70 sites in United States, Australia and 6 more
- Volunteers
- 220 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Study to Evaluate the Non-inferiority of Cavir in HBeAg(+)Chronic Hepatitis B Patients Treated With Baraclude
Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.
- Trial name
- NCT02523547
- Testing
- Cavir, Baraclude
- Where
- South Korea
- Volunteers
- 134 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Hepatitis B, Chronic
Study of Safety and Tolerability of DCR HBVS
DCR-HBVS will be evaluated for safety and efficacy in healthy volunteers and chronic hepatitis B patients.
- Trial name
- NCT03772249
- Testing
- DCR-HBVS
- Where
- 9 sites in Australia, Hong Kong and 3 more
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Hepatitis B, Chronic
Suboptimal Responders to Adefovir Switching to Entecavir
Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir
- Trial name
- NCT00718887
- Testing
- Entecavir, Adefovir/Entecavir
- Where
- 8 sites in China
- Volunteers
- 228 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C, Chronic
A Phase 1 Study of PPI-668 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) Genotype 1
PPI-668 is an antiviral agent (a hepatitis C NS5A inhibitor) that is being developed as a potential treatment for hepatitis C virus infection.
- Trial name
- NCT01448200
- Testing
- PPI-668
- Where
- 7 sites in United States, Australia and 1 more
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Presidio Pharmaceuticals, Inc.
Hepatitis C, Chronic
A Phase 1a/1b Study of PPI-383 in Healthy Adults and Hepatitis C Patients
PPI-383 is an antiviral agent (an inhibitor of the hepatitis C virus NS5B polymerase) that is being developed as a potential treatment for hepatitis C virus infection.
- Trial name
- NCT01928147
- Testing
- PPI-383
- Where
- 6 sites in Mauritius, United Kingdom
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Presidio Pharmaceuticals, Inc.
Chronic Hepatitis C
A Drug-Drug Interaction Study Evaluating the Combination of IDX320 and IDX184 in Healthy Participants (MK-6844-002)
This study is designed to evaluate the potential for a pharmacokinetic (PK) drug-drug interaction between IDX320 and IDX184 and to assess the safety and tolerability when the two drugs are administered in combination in healthy…
- Trial name
- NCT01157104
- Testing
- IDX320, IDX184
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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