Clinical trials: Human
Metastatic Breast Cancer
Corrected QT Interval Effects of Trastuzumab Emtansine (T-DM1) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer and the Safety and Tolerability of Combined T-DM1 and Pertuzumab in Patients With Early Disease Progression
This is a multicenter, open-label, single-arm Phase II study designed to evaluate the effect of T-DM1 on the duration of corrected QT (QTc) interval in patients with HER2-positive locally advanced or metastatic breast cancer and…
- Trial name
- NCT00943670
- Testing
- pertuzumab, Trastuzumab emtansine [Kadcyla]
- Volunteers
- 51 people
- Sponsor
- Genentech, Inc.
AML
Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)
Open-label, multi-dose, single-arm, multi-center, Phase 1/2 study conducted in three segments: the Single Patient Dose Escalation Segment (complete), followed by the Multi-Patient Dose Escalation Segment (complete) and the…
- Trial name
- VOYAGE (NCT02152956)
- Testing
- Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off, Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off, Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
- Where
- 43 sites in United States, France and 6 more
- Volunteers
- 244 people
- Sponsor
- MacroGenics
Cystinosis
Phase 3 Study of Cysteamine Bitartrate Delayed-release (RP103) Compared to Cystagon® in Patients With Cystinosis
Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate) which must be taken every six hours for the…
- Trial name
- NCT01000961
- Testing
- Cystagon® (Cysteamine Bitartrate), Cysteamine Bitartrate Delayed-release Capsules (RP103)
- Where
- 8 sites in United States, France and 1 more
- Volunteers
- 43 people
- Sponsor
- Amgen
Human Immunodeficiency Virus 1
A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication), safety and antiviral activity to support dose recommendations by body weight of darunavir with low-dose ritonavir (DRV/rtv), in…
- Trial name
- NCT00919854
- Testing
- Darunavir, Ritonavir
- Where
- 8 sites in Argentina, Brazil and 3 more
- Volunteers
- 27 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Hepatitis C, Chronic
Safety and Efficacy of Vaniprevir (MK-7009) With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-Experienced Hepatitis C Virus (HCV) Participants (MK-7009-009)
The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV.
- Trial name
- NCT00704405
- Testing
- Vaniprevir, Pegylated Interferon (Peg-IFN), Ribavirin (RBV)
- Volunteers
- 285 people
- Sponsor
- Merck Sharp & Dohme LLC
Infection, Human Immunodeficiency Virus I
48-Week Study Of GW433908 And Ritonavir Or GW433908 Alone, Twice Daily In Pediatric Patients With HIV Infection
This is a 48-week study to collect information on the safety and activity of an investigational medicine in patients, ages 2 to 18 years old, with HIV infection .
- Trial name
- NCT00089583
- Testing
- LEXIVA (GW433908), Ritonavir
- Where
- 39 sites in United States, Belgium and 5 more
- Volunteers
- 110 people
- Sponsor
- ViiV Healthcare
Behavior, Cardiovascular Risk Factor
The Oakland Men's Health Disparities Study
Reducing racial disparities in health outcomes is a major policy concern in the United States. Although there has been recent progress to close the gap, black men continue to experience earlier morbidity and mortality from…
- Conditions
- Behavior, Cardiovascular Risk Factor, Influenza
- Trial name
- NCT03481270
- Testing
- Concordant
- Where
- United States
- Volunteers
- 1,374 people, healthy volunteers welcome
- Sponsor
- Stanford University
Infection, Human Immunodeficiency Virus
A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers
Lamivudine (3TC) is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and children.
- Trial name
- NCT02634073
- Testing
- Lamivudine, Sorbitol
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Influenza
Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children
The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.
- Trial name
- NCT00980005
- Testing
- GSK investigational vaccine GSK1557482A, Fluzone®
- Where
- 28 sites in United States
- Volunteers
- 2,116 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infertility
Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)
This is a Phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to assess the safety and efficacy of Pergoveris® (recombinant human follicle stimulating hormone [r-hFSH]/recombinant human luteinising…
- Trial name
- ESPART (NCT02047227)
- Testing
- Pergoveris®, GONAL-f®, Recombinant human chorionic gonadotrophin (r-hCG)
- Where
- Germany
- Volunteers
- 939 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Recurrent Chronic Hepatitis C Virus, Post Liver Transplant
Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant
This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C.
- Trial name
- NCT01687270
- Testing
- Sofosbuvir, RBV
- Where
- 12 sites in United States, France and 3 more
- Volunteers
- 40 people
- Sponsor
- Gilead Sciences
Diabetes Mellitus, Type 1
Efficacy and Safety of Inhaled Insulin Compared With Subcutaneous Human Insulin Therapy in Adults With Type 1 Diabetes
This study is being done to find out the good and bad effects of a drug that is not approved for sale and the effects if any on measures of pulmonary function in adult males and females with type 1 diabetes mellitus.
- Trial name
- NCT00137046
- Testing
- Subcutaneous Insulin, Inhaled Insulin
- Where
- 73 sites in United States, Argentina and 3 more
- Volunteers
- 582 people
- Sponsor
- Pfizer
Healthy Aging
Beta-glucan and Immune Response to Influenza Vaccine
This trial in healthy adults will determine the effects of beta-glucan, a dietary fiber supplement isolated from baker's yeast, on immune response to the influenza vaccine.
- Trial name
- M-Unity (NCT05074303)
- Testing
- Influenza Vaccine, Beta-glucan
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- University of Florida
Chronic Hepatitis C
Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study
The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in…
- Trial name
- NCT02798315
- Volunteers
- 40 people
- Sponsor
- AbbVie
Chronic Hepatitis C
Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 …
- Trial name
- NEUTRINO (NCT01641640)
- Testing
- Sofosbuvir, RBV, PEG
- Where
- 56 sites in United States, Puerto Rico
- Volunteers
- 328 people
- Sponsor
- Gilead Sciences
Hepatitis B
A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection
The purpose of this study is to assess changes in intrahepatic hepatitis B surface antigen (HBsAg) between baseline and on-treatment liver biopsy in response to JNJ-3989-based combination treatment.
- Trial name
- INSIGHT (NCT04585789)
- Testing
- JNJ-73763989, JNJ-56136379, Entecavir (ETV)
- Where
- 10 sites in United States, Belgium and 7 more
- Volunteers
- 24 people
- Sponsor
- Janssen Research & Development, LLC
Pain
Unmodulated 5 Kilohertz Currents Versus TENS: Effect on Pain Thresholds, Tactile Threshold, and Nerve Conduction
The purpose of this study is to determine whether the transcutaneous application of unmodulated 5 Kilohertz (KHz) alternating currents are effective in decreasing the thermal and mechanical experimental pain and cause changes in…
- Trial name
- NCT02320838
- Testing
- 5 KHz, TENS
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- University of Castilla-La Mancha
Influenza Virus
Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.
Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to <72 Months of Age.
- Trial name
- NCT01964989
- Testing
- Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV), Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)
- Where
- 167 sites in United States, Canada and 9 more
- Volunteers
- 10,644 people, healthy volunteers welcome
- Sponsor
- Seqirus
Diabetes Mellitus, Type 1, Type 1 Diabetes
Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings
The primary objective of this trial is to determine whether insulin glargine reduces the risk of serious hypoglycemia or improves Time in Range at 6 months when compared against standard of care human insulin (e.g.
- Trial name
- HumAn-1 (NCT05614089)
- Testing
- Insulin Glargine, NPH or premixed 70/30 (human insulin)
- Where
- 3 sites in Bangladesh, Tanzania
- Volunteers
- 400 people
- Sponsor
- Jing Luo
Embryonic Development, Embryo Morphokinetics
Embryo Culture Under Constant 5% vs Gradient 8%, 5%, 2% Oxygen Concentration
The purpose of this study is to investigate the development of human embryos in vitro under two different oxygen concentrations; a static 5% during all five days of culture or under an oxygen gradient, starting with 8% from day-0…
- Conditions
- Embryonic Development, Embryo Morphokinetics, Embryo Morphometry
- Trial name
- NCT05898178
- Testing
- Experimental intervention: 8-5-2% oxygen gradient concentration in the incubator
- Where
- Slovenia
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- University Medical Centre Maribor
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