Clinical trials: Human
Neoplasms
BI 6727 (Volasertib) Human ADME Trial in Various Solid Tumours
Investigation of absorption, distribution, metabolism and excretion (ADME) and assessment of safety, tolerability and preliminary therapeutic effects of [14C]volasertib in patients with advanced solid tumours.
- Trial name
- NCT01145885
- Testing
- BI 6727
- Where
- Hungary
- Volunteers
- 7 people
- Sponsor
- Boehringer Ingelheim
HIV, AIDS
Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice Populations
Specific Aim: To conduct a randomized, placebo-controlled trial of extended release-naltrexone (XR-NTX) among Human Immunodeficiency Virus (HIV) infected prisoners meeting Diagnostic Statistical Manual IV (DSM-IV) criteria for…
- Conditions
- HIV, AIDS, Opioid Dependence, Drug Dependence
- Trial name
- NewHope (NCT01246401)
- Testing
- Extended-Release Naltrexone
- Where
- 3 sites in United States
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Yale University
Alzheimer's Disease
A First in Human Study of IBC-Ab002 in Persons With Early Alzheimer's Disease (AD)
This is a randomized, double-blind, placebo-controlled first-in-human, Phase 1, safety, tolerability, pharmacokinetic (PK) and preliminary exploratory activity study of escalating multiple intravenous (IV) doses of IBC-Ab002 in…
- Trial name
- NCT05551741
- Testing
- IBC-Ab002
- Where
- 10 sites in Israel, Netherlands and 1 more
- Volunteers
- 40 people
- Sponsor
- Immunobrain Checkpoint
Chronic Hepatitis C Virus
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects…
- Trial name
- ION-2 (NCT01768286)
- Testing
- LDV/SOF, RBV
- Where
- 53 sites in United States
- Volunteers
- 441 people
- Sponsor
- Gilead Sciences
Prevention of HPV Types 16- and 18-related Cervical Cancer, Cervical Intraepithelial Neoplasia (CIN) 1/2/3, and Cervical Adenocarcinoma in Situ
A Study to Evaluate the Immunogenicity, Safety and Tolerability of Quadrivalent Human Papillomavirus Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years (V501-213)
This study is designed to evaluate the immunogenicity, safety, and tolerability of Gardasil® (quadrivalent human papillomavirus [qHPV] vaccine, V501) in Chinese girls aged 9-19 years and young women aged 20-26 years.
- Trial name
- NCT03493542
- Testing
- V501
- Where
- China
- Volunteers
- 766 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Hepatitis C, Chronic
The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study
Direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) offers a cure to those with chronic HCV infection. For marginalized communities, linkage to care services often aren't enough to overcome barriers to accessing the…
- Trial name
- NOW (NCT03987503)
- Testing
- Epclusa (SOF/VEL), Standard of care, Fibroscan® 430 Mini Plus
- Where
- United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV Infections
A Safety, Tolerability, Acceptability, and Pharmacokinetic (PK) Study of Cabotegravir (CAB) in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Chinese Men
The pre-exposure prophylaxis (PrEP) is an important component in the overall strategy for prevention of HIV infection. Cabotegravir (CAB) is an integrase strand transfer inhibitor currently in development for treatment and…
- Trial name
- NCT03422172
- Testing
- Oral CAB, CAB LA
- Where
- 3 sites in China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Dengue
An Evaluation of Repeated Oral Doses of JNJ-64281802 Against DENV-3 Challenge
The investigational study drug, JNJ-64281802, is being developed for the prevention and treatment of dengue infection. This study is hypothesizing that the highest dose of the investigational study drug is superior to receiving a…
- Trial name
- NCT05048875
- Testing
- Cohort 1 - Group 1 JNJ High Dose, Cohort 1 - Group 2 JNJ Medium Dose, Cohort 1 - Group 2 JNJ Low Dose
- Where
- 2 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Influenza
A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza
This partially randomized, multi-center parallel-group study will evaluate the safety, pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in patients with influenza.
- Trial name
- NCT01050257
- Testing
- Oseltamivir IV, Oseltamivir Oral
- Where
- 96 sites in United States, Denmark and 7 more
- Volunteers
- 118 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C
Staged Phase I/II Hepatitis C Prophylactic Vaccine
A two stage, phase I/II, double-blinded, randomized, placebo-controlled study of hepatitis C virus (HCV)uninfected male and female injection drug users (IDU) aged 18 to 45.
- Trial name
- NCT01436357
- Testing
- AdCh3NSmut1, MVA-NSmut
- Where
- 5 sites in United States
- Volunteers
- 548 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Hepatitis C, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3
This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3.
- Trial name
- NCT01258101
- Testing
- peginterferon alfa-2a [Pegasys], ribavirin
- Where
- 18 sites in Austria
- Volunteers
- 395 people
- Sponsor
- Hoffmann-La Roche
Respiratory Distress Syndrome in Premature Infant, Bronchopulmonary Dysplasia
Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome
Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical ventilation and infection.
- Trial name
- NCT01941745
- Testing
- Half normal saline, Low Dose rhCC10, High dose rhCC10
- Where
- 3 sites in United States
- Volunteers
- 88 people
- Sponsor
- Tufts Medical Center
Idiopathic Pulmonary Fibrosis
A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic…
- Trial name
- STARSCAPE-OLE (NCT04594707)
- Testing
- PRM-151 (Zinpentraxin Alfa)
- Where
- 248 sites in United States, Argentina and 26 more
- Volunteers
- 117 people
- Sponsor
- Hoffmann-La Roche
Infection, Human Immunodeficiency Virus
Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine
This study aims to compare the bioequivalence of two experimental fixed dose combination (FDC) tablets versus single entity products of dolutegravir (DTG) and lamivudine (3TC) in healthy adult subjects.
- Trial name
- NCT03078556
- Testing
- Dolutegravir, Lamivudine, Dolutegravir + Lamivudine FDC Formulation 1
- Where
- United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Obesity
Pharmacokinetics of Oseltamivir Carboxylate In Morbidly Obese Subjects
One in three Americans are obese. Obese subjects may or may not need higher doses of the anti-flu drug known as Tamiflu (oseltamivir).
- Trial name
- NCT01179919
- Testing
- Oseltamivir
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Manjunath Prakash Pai
Hepatitis C
A Multiple Dose Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Participants (MK-5172-010)
The goal of this study was to compare hepatic pharmacokinetics (PK) derived from liver tissue to plasma PK after administration of grazoprevir (MK-5172) to participants with chronic hepatitis C virus (HCV) infection.
- Trial name
- NCT01537900
- Testing
- Grazoprevir
- Volunteers
- 4 people
- Sponsor
- Merck Sharp & Dohme LLC
Restrictive Scar Contracture, Restrictive Hypertrophic Scar
A Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures
The primary objective of this study is to evaluate the safety of ICX-RHY-013 in the treatment of stable, restrictive scars in subjects who have suffered a burn injury.
- Conditions
- Restrictive Scar Contracture, Restrictive Hypertrophic Scar, Burn Scar Contractures, Burn Scar
- Trial name
- NCT01564407
- Testing
- ICX-RHY-013
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of Pittsburgh
Acromegaly
Single Dose Pharmacology Study of DG3173 and Octreotide in Acromegalic Patients.
The study is designed to investigate the safety, tolerability and efficacy of DG3173 in untreated acromegaly patients. Twenty patients received ascending single doses of DG3173 and one dose of octreotide, the current gold…
- Trial name
- NCT02235987
- Testing
- octreotide, DG3173
- Volunteers
- 20 people
- Sponsor
- Aspireo Pharmaceuticals Limited
Bladder Cancer, Pancreas Cancer
A Study to Determine Best Tumor Response With Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2 (HER2) Overexpressing Solid Tumors
This multicenter, non-randomized, Phase II study will assess the efficacy, safety, and pharmacokinetics of trastuzumab emtansine in participants with HER2 overexpressing locally advanced (unresectable and not treatable with…
- Conditions
- Bladder Cancer, Pancreas Cancer, Cholangiocellular Carcinoma
- Trial name
- KAMELEON (NCT02999672)
- Testing
- Trastuzumab Emtansine
- Where
- 16 sites in Italy, Netherlands and 2 more
- Volunteers
- 20 people
- Sponsor
- Hoffmann-La Roche
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