Clinical trials: Human
Hepatitis B, Polio
Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series.
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis
- Trial name
- NCT00315055
- Testing
- DTaP-IPV-HB-PRP~T vaccine, DTaP-IPV//PRP~T combined, Hepatitis B vaccine
- Where
- Turkey (Türkiye)
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis C, HIV Infections
Coaching for HCV and HIV
The objective of this study is to determine the feasibility and acceptability of a peer recovery coach (PRC) intervention to improve linkage to hepatitis C (HCV) and/or human immunodeficiency virus (HIV) care, treatment…
- Conditions
- Hepatitis C, HIV Infections, Opioid-use Disorder
- Trial name
- NCT04314414
- Testing
- PRC brief motivational interview intervention, Phone contact
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Boston Medical Center
Hepatitis C
Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)
A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus…
- Trial name
- NCT00704184
- Testing
- Comparator: Vaniprevir, Comparator: Pegylated-Interferon (Peg-IFN), Comparator: Ribavirin
- Volunteers
- 95 people
- Sponsor
- Merck Sharp & Dohme LLC
Multiple Myeloma
First in Human Dose Escalation of M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone
The purpose of this study was to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and early efficacy signs of M3258 as a single agent and co-administered with dexamethasone in participants with Relapsed…
- Trial name
- NCT04075721
- Testing
- M3258, M3258 20 mg
- Where
- 7 sites in United States, France
- Volunteers
- 10 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Solid Tumors
A Study of RO7172508 in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors
This study was to determine the maximum-tolerated dose (MTD) and/or the optimal biological dose (OBD) as well as the optimal schedule for intravenous (IV) and subcutaneous (SC) administrations of RO7172508 as monotherapy, with or…
- Trial name
- NCT03539484
- Testing
- RO7172508, Obinutuzumab, Tocilizumab
- Where
- 6 sites in Belgium, Canada and 2 more
- Volunteers
- 26 people
- Sponsor
- Hoffmann-La Roche
HIV
A Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRCHIVMAB0115-00-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults
Background: HIV causes AIDS, a serious disease that can lead to fatal infections. HIV infection can be controlled but not cured, nor is there a vaccine to prevent it.
- Trial name
- NCT05627258
- Testing
- VRC-HIVMAB0115-00-AB
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hepatitis C
Study of CTS-1027 in Combination With Pegylated Interferon and Ribavirin in Hepatitis C Virus (HCV) Null-Responders
The purpose of this study is to determine if the combination treatment of CTS-1027, pegylated interferon and ribavirin can improve the response rates in HCV patients who did not previously respond to pegylated interferon and…
- Trial name
- CTS-1027-04 (NCT01051921)
- Testing
- CTS-1027, Pegylated interferon, Ribavirin
- Where
- 15 sites in United States, Puerto Rico
- Volunteers
- 67 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Hepatitis C, Chronic
A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection
The purpose of this study is to evaluate the pharmacokinetic interactions between simeprevir and ledipasvir in a treatment regimen consisting of simeprevir (SMV), sofosbuvir (SOF), and ledipasvir (LDV) in treatment-naive…
- Trial name
- NCT02421211
- Testing
- Simeprevir (SMV), Ledipasvir (LDV), Sofosbuvir (SOF)
- Where
- 4 sites in Belgium
- Volunteers
- 41 people
- Sponsor
- Janssen Sciences Ireland UC
Healthy Volunteers
A Combined SAD and MAD Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088
This is the first study of single and multiple doses of IFB-088 in human subjects. The current study is designed to assess in the first part, the safety, tolerability, plasma and urine pharmacokinetics (PK) of single oral doses…
- Trial name
- NCT03610334
- Testing
- IFB-088 (2.5-60.0mg) oral capsule, IFB-088 (15.0-50.0mg) oral capsule
- Where
- 2 sites in France
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- InFlectis BioScience
Hepatitis C Virus, HIV
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and…
- Trial name
- NCT02073656
- Testing
- LDV/SOF, RBV
- Where
- 41 sites in United States, Canada and 2 more
- Volunteers
- 335 people
- Sponsor
- Gilead Sciences
Graft Rejection
A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection
The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1 Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated Rejection (AMR).
- Trial name
- NCT01147302
- Testing
- C1 Esterase Inhibitor (Human)
- Where
- 5 sites in United States, Germany
- Volunteers
- 18 people
- Sponsor
- Shire
Chronic Hepatitis C Infection
Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)
The purpose of this study is to study the effects of valacyclovir on patients who have hepatitis C and antibodies to herpes simplex type-2. Herpes simplex type 2 is a virus which causes genital herpes.
- Trial name
- NCT01453075
- Testing
- Valacyclovir
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Influenza
Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine
To provide Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2007-2008 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study.
- Trial name
- NCT00561002
- Testing
- 2007-2008 Influenza Virus Vaccine
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Rheumatoid Arthritis
First in Human Study of a Monoclonal Antibody (SOL-116) Targeting BSSL (Bile Salt-Stimulated Lipase), Single and Multiple Dose Parts
This is a randomized, double-blind, placebo-controlled, first-in-human phase I study. It consists of a single ascending dose part in healthy subjects (Part 1) and in patients with rheumatoid arthritis (Part 2) as well as a…
- Trial name
- NCT05576012
- Testing
- SOL-116
- Where
- 2 sites in Netherlands
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Lipum AB
Influenza, Multiple Myeloma
Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients
The investigators' hypothesis is that the administration of Fluzone® High-Dose with booster to all patients with monoclonal gammopathies (irrespective of age) will lead to seroconversion rates exceeding 50% and more importantly…
- Conditions
- Influenza, Multiple Myeloma, Waldenstrom's Macroglobulinemia, Plasma Cell Disorders
- Trial name
- SHIVERING 2 (NCT02566265)
- Testing
- Fluzone High Dose Vaccine
- Where
- United States
- Volunteers
- 122 people
- Sponsor
- Yale University
Analgesia, Obstetrical, Coagulation Defect; Postpartum
IV Ketorolac on Platelet Function Post-Cesarean Delivery
Cesarean delivery has become the most common surgical procedure in the US. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to improve the quality of post-cesarean analgesia and markedly reduce opioid consumption.
- Conditions
- Analgesia, Obstetrical, Coagulation Defect; Postpartum, Nonsteroidals (NSAIDs)Toxicity, Postpartum Hemorrhage
- Trial name
- KetoPltAgg (NCT03805607)
- Testing
- Ketorolac Tromethamine 30 MG/ML
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Hemophilia A
A Study of Recombinant AAV2/6 Human Factor 8 Gene Therapy SB-525 (PF-07055480) in Subjects With Severe Hemophilia A
The purpose of the study is to evaluate the safety, tolerability and time-course profile of FVIII activity after dosing with SB-525 (PF-07055480)
- Trial name
- NCT03061201
- Testing
- SB-525 (PF-07055480)
- Where
- 22 sites in United States
- Volunteers
- 13 people
- Sponsor
- Pfizer
Breast Cancer
Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment
The purpose of this multi-centre, randomised, double-blind, parallel-group study is to compare efficacy and safety between anastrozole and tamoxifen in pre- and post-operative administration under goserelin acetate treatment for…
- Trial name
- NCT00605267
- Testing
- Tamoxifen, Anastrazole (Arimidex), Goserelin acetate (Zoladex)
- Where
- 4 sites in Japan
- Volunteers
- 197 people
- Sponsor
- AstraZeneca
Sex, Cigarette Smoking
Mapping Brain Glutamate in Humans: Sex Differences in Cigarette Smokers
The proposed study evaluated sex differences in glutamate (Glu), with a focus on the dorsal anterior cingulate cortex (dACC), anterior insula, and thalamus, as well as how it is influenced by sex (males vs.
- Trial name
- NCT05279053
- Testing
- Abstinence and Smoking
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
Hepatitis B
Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With Engerix™-B Vaccine.
This study will evaluate the immune response of healthy subjects who received neonatal vaccination course with GSK Biologicals' Engerix™-B vaccine, approximately 20 years ago.
- Trial name
- NCT00774995
- Testing
- EngerixTM-B
- Where
- Thailand
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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