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Virus Diseases clinical trials

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NCT ID: NCT02313844 Withdrawn - BK Virus Infection Clinical Trials

Most Closely Human Leukocyte Antigen (HLA)-Matched BK Virus-specific T Lymphocytes (Viralym-B)

Start date: March 1, 2018
Phase: Phase 1
Study type: Interventional

Patients enrolled on this study will have received a stem cell transplant. After a transplant, while the immune system grows back the patient is at risk for infection. Some viruses can stay in the body for life, and if the immune system is weakened (like after a transplant), they can cause life-threatening infections. BK virus (BKV) is a virus that can cause serious life-threatening infections in patients who have weak immune systems. It affects the urinary tract, and can cause frequent urination, blood in the urine, and severe pain. Investigators want to see if they can use a kind of white blood cell called T cells to treat BKV infections that occur after a transplant. Investigators have observed in other studies that treatment with specially trained T cells has been successful when the cells are made from the transplant donor. However as it takes 1-2 months to make the cells, that approach is not practical when a patient already has an infection. Investigators have now generated BKV-specific T cells from the blood of healthy donors and created a bank of these cells. Investigators have previously successfully used frozen virus-specific T cell lines generated from healthy donors to treat virus infections after bone marrow transplant, and have now improved the production method and customized the bank of lines to specifically and exclusively target BKV. In this study, investigators want to find out if the banked BKV-specific T cells derived from healthy donors are safe and can help to treat BK virus infection. The BKV-specific T cells (Viralym-B) are an investigational product not approved by the Food and Drug Administration (FDA).

NCT ID: NCT02311387 Completed - Clinical trials for Lassa Virus Infection

Seroprevalence and Incidence of Lassa Fever in the Rural Commune of Sibirila, District of Bougouni, Mali

Start date: December 5, 2014
Phase:
Study type: Observational

Background: - Lassa fever is very similar to other diseases that cause fever, such as malaria and yellow fever. People get Lassa fever from mice. A person can get Lassa fever from mice urine and droppings. When a group of researchers tested the mice in Soromba, Mali, they found that many were infected with Lassa fever. Lassa fever may also be passed through body fluids (like blood or semen) of people infected with Lassa fever. Researchers want to study this disease to help the government better protect the health of people in Sibirila. Objectives: - To find out how many people in Sibirila have ever had Lassa fever. Also, to measure how many people get the disease every year. Eligibility: - People age 6 months and older who are residents of Soromba, Bamba, or Banzana with no plans to relocate within 1 year. Design: - Households will be randomly selected to participate in the study. - Participants will have up to 20 drops of blood collected from the finger or heel. - Participants will be asked about their age. They will be asked if they have ever had a fever and if they have ever seen mice in or around their home. - Researchers will come back in 1 year and take another drop of blood from the participant. Participants will be asked the same questions. - If a participant has a fever at any time during the year, he or she should go to the health center. Researchers will collect a few drops of blood to test for Lassa fever. ...

NCT ID: NCT02309918 Completed - Acute Hepatitis C Clinical Trials

HepNet Acute HCV IV - LDV/SOF FDC in Acute Genotype 1 Hepatitis C Virus Infection

Start date: November 2014
Phase: Phase 2
Study type: Interventional

This is an open-label, single arm, multicenter, pilot-study to compare the efficacy and safety of LDV/SOF fixed dose combination (FDC) in subjects with acute genotype 1 HCV infection. A total of 20 subjects will be assigned to receive LDV/SOF FDC tablet (LDV 90 mg/SOF 400 mg/) once daily for 6 weeks.Patients will be followed up for 24 weeks.

NCT ID: NCT02309320 Completed - Clinical trials for Respiratory Syncytial Virus Infection

A Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171

Start date: December 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of the study is to investigate the safety and tolerability of ALX-0171. The secondary objectives are to evaluate the clinical effect of ALX-0171 and to explore the pharmacodynamics (PD) and the systemic pharmacokinetics (PK) of ALX-0171.

NCT ID: NCT02307591 Withdrawn - Ebola Virus Disease Clinical Trials

Clinical Study to Assess Efficacy and Safety of Amiodarone in Treating Patients With Ebola. Virus Disease (EVD) in Sierra Leone. EASE (EMERGENCY Amiodarone Study Against Ebola)

EASE
Start date: December 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of amiodarone in the treatment of patients afflicted with Ebola virus disease.

NCT ID: NCT02301936 Completed - Clinical trials for Hepatitis C Virus Infection

Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Adults With Sickle Cell Disease

Start date: March 2, 2015
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle cell disease (SCD).

NCT ID: NCT02300103 Completed - Clinical trials for Hepatitis C Virus Infection

Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study

Start date: December 1, 2014
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead sponsored study and did not achieve sustained virologic response (SVR).

NCT ID: NCT02297594 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Safety, Tolerability and PK Study of AK0529 in Healthy Human

Start date: October 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and PK of single and multiple ascending dose of AK0529 when administered orally in healthy subjects

NCT ID: NCT02296983 Active, not recruiting - Ebola Virus Disease Clinical Trials

A Study to Find Out if the New Ebola Vaccine is Safe and Stimulates Immunity That Might Protect Adults in Kilifi, Kenya.

Start date: December 2014
Phase: Phase 1
Study type: Interventional

Previous Ebola outbreaks have been limited to individual countries and contained by infection control activities. The current outbreak in West Africa is international, and air travel has resulted in a number of infected travellers crossing national borders. There are currently no specific treatments generally available for Ebola and the mortality is high, particularly in countries with limited intensive care facilities. There is currently no vaccine and the personal protection required by healthcare workers treating patients is cumbersome and requires full compliance to be protective. There is now a consortium (VEBCON collaboration) of four clinical centres (in Kenya, Gabon, Switzerland and Germany), WHO and New Link Genetics (the vaccine manufacturer) under which this study will be conducted. The investigators are conducting this trial, a Phase I, open-label, dose escalation trial, designed to establish safety, tolerability and immunogenicity of two doses of VSVΔG-ZEBOV, an Ebola Virus Vaccine Candidate for the first time in sub-Saharan African populations. The investigators plan to vaccinate 40 volunteers in Kenya. The trial will be conducted at the KEMRI-CGMR Coast site where healthcare workers (both clinical and laboratory) will be the primary target population as they are likely to be the recipients of a protective vaccine. The investigators will vaccinate a cohort of 20 volunteers at a low dose and then vaccinate a further cohort of 20 volunteers at full dose. Each volunteer will receive one dose of the vaccine. The investigators will follow them up for a period of one year looking to their safety and immunogenicity endpoints.

NCT ID: NCT02295501 Terminated - Clinical trials for Acute Ebola Virus Disease

A Prospective, Open Label, Phase 1 Safety Study of Passive Immune Therapy During Acute Ebola Virus Disease Using Transfusion of INTERCEPT Plasma Prepared From Volunteer Donors Who Have Recovered From Ebola Virus Disease

Start date: December 2014
Phase: Phase 1
Study type: Interventional

The objective of this Phase 1 safety study is to provide access to the potential therapeutic benefit of EBOV convalescent plasma containing antibodies to EBOV. The risk of exposure to plasma from donors who may be infected with other transfusion-transmitted pathogens, not detectable by current licensed donor testing procedures, will be mitigated by using pathogen inactivation to minimize the risk of the TTI from these donors, who would otherwise be deferred and ineligible for blood donation.