Clinical trials: Chronic Infection
- Condition Chronic Infection
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Hepatitis C Virus (HCV)
A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection
The objectives of this study are to assess the pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir adult formulation in adolescents ages 12 to 17 years and a pediatric formulation of glecaprevir and pibrentasvir in…
- Trial name
- DORA (NCT03067129)
- Testing
- Glecaprevir/Pibrentasvir Adult Formulation, Glecaprevir + Pibrentasvir Pediatric Formulation
- Where
- 38 sites in United States, Belgium and 7 more
- Volunteers
- 129 people
- Sponsor
- AbbVie
Hepatitis C Virus Infection
Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection
This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase. The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm the dose of sofosbuvir/velpatasvir (SOF/VEL)…
- Trial name
- NCT03022981
- Testing
- SOF/VEL
- Where
- 27 sites in United States, Belgium and 2 more
- Volunteers
- 216 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus
Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a…
- Trial name
- PEDESTAL (NCT01598090)
- Testing
- Peginterferon Lambda-1a, Peginterferon Alfa-2a, Ribavirin
- Where
- 104 sites in United States, Austria and 13 more
- Volunteers
- 881 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B
A Phase IIIb: Long-Term Outcomes for Hepatitis B (HepB) Patients in Some Previous Entecavir (ETV) Trials
The purpose of this study is to follow patients treated in entecavir Phase III and rollover studies for safety experience and Hepatitis B virus (HBV)-related complications.
- Trial name
- NCT01337479
- Volunteers
- 1,097 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis B
A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B
This study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) with Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the…
- Trial name
- NCT00057265
- Testing
- telbivudine or lamivudine
- Where
- 11 sites in United States, South Korea and 4 more
- Sponsor
- Novartis
Cystic Fibrosis, Pseudomonas Aeruginosa
Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways
This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation…
- Trial name
- PALS (NCT01404234)
- Testing
- AZLI
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 61 people
- Sponsor
- Gilead Sciences
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
Cystic Fibrosis
A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
This is a 48-week extension study to CMA-0631-PR-0010 Core Study. Patients who have a positive culture for P. aeruginosa at visit 4 of the first 8-week core study period and/or if deemed appropriate by the Investigators will be…
- Trial name
- CT03Ext (NCT01111383)
- Testing
- tobramycin
- Where
- 20 sites in France, Poland and 1 more
- Volunteers
- 209 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Hunter Syndrome
Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment
Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter…
- Trial name
- AIM-IT (NCT02055118)
- Testing
- idursulfase-IT, No IT treatment
- Where
- 9 sites in United States, Australia and 5 more
- Volunteers
- 58 people
- Sponsor
- Shire
Refractory Bone or Joint Infections
Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections
To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.
- Trial name
- NCT02569541
- Testing
- sodium fusidate
- Where
- 19 sites in United States
- Volunteers
- 30 people
- Sponsor
- Arrevus Inc.
B-cell Acute Lymphoblastic Leukemia, Large B-cell Lymphoma
Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
This is a Phase 1/2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19-positive hematologic malignancies.
- Conditions
- B-cell Acute Lymphoblastic Leukemia, Large B-cell Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Trial name
- NCT06533579
- Testing
- Dose Level 1, VNX-101, Dose Level 2, VNX-101, Dose Level 3, VNX-101
- Where
- 11 sites in United States
- Volunteers
- 32 people
- Sponsor
- Vironexis Biotherapeutics Inc.
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection
The primary objective of the PK Lead-in Phase of the study is to evaluate the steady state pharmacokinetics (PK) and confirm the dose of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis C virus…
- Trial name
- NCT02249182
- Testing
- LDV/SOF, RBV
- Where
- 31 sites in United States, Australia and 2 more
- Volunteers
- 226 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic Hepatitis
Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection
The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection
- Trial name
- NCT03487848
- Testing
- Daclatasvir, Sofosbuvir
- Where
- 2 sites in Australia, Spain
- Volunteers
- 5 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C Virus (HCV)
Study of Oral Glecaprevir/Pibrentasvir Tablets in Participants Aged 12 Years or Older With Chronic Hepatitis C to Assess Sustained Virological Response
Hepatitis C virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged.
- Trial name
- CHOICE (NCT04577482)
- Where
- 10 sites in Russia
- Volunteers
- 42 people
- Sponsor
- AbbVie
Chronic Disease, HIV/AIDS
Observational Pharmaco-Epidemiology Research & Analysis
Greater advances are needed in two separate but related areas in healthcare: 1) the Clinical Decision Support Systems that complement the EHR use in support of routine patient care, population management and disease management…
- Conditions
- Chronic Disease, HIV/AIDS, Liver Diseases, Inflammatory Bowel Diseases
- Trial name
- OPERA (NCT03813862)
- Testing
- Non-interventional (observational only)
- Where
- United States
- Volunteers
- 2,000,000 people, healthy volunteers welcome
- Sponsor
- Epividian
Hepatitis B Virus (HBV)
Evaluation of Tenofovir Disoproxil Fumarate in Adolescents With Chronic Hepatitis B Infection
The primary purpose of the study is to evaluate the effectiveness, safety, and tolerability of tenofovir disoproxil fumarate (TDF) in adolescents (aged 12-17 years) with chronic hepatitis B virus (HBV) infection.
- Trial name
- NCT00734162
- Testing
- Tenofovir disoproxil fumarate (TDF)
- Where
- 21 sites in United States, Bulgaria and 5 more
- Volunteers
- 106 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection
The goals of this clinical study are to compare the effectiveness, safety and tolerability of study drug, tenofovir alafenamide (TAF), versus placebo in teens and children with CHB and to learn more about the dosing levels in…
- Trial name
- NCT02932150
- Testing
- TAF
- Where
- 39 sites in United States, Belgium and 6 more
- Volunteers
- 150 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic
Systematic Review of Antiretroviral Treatments for Chronic Hepatitis B (CHB)
The purpose of this study is to support the clinical value of entecavir by assessing the relationship between viral load and histological improvement.
- Trial name
- NCT01155427
- Volunteers
- 100 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis C
Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034)
This is a three-part (Part A, Part B, and Part C), open-label, multicenter study of boceprevir in pediatric participants with chronic hepatitis C (CHC) genotype 1 (GT1).
- Trial name
- NCT01590225
- Testing
- Boceprevir, Peginterferon alpha-2b, Ribavirin
- Sponsor
- Merck Sharp & Dohme LLC
COPD, Emphysema or COPD
Crossover Blinded Trial of Cell Therapy Versus Placebo in COPD
The aim of this randomized, controlled crossover designed study is to compare the outcomes of receiving autologous, adult stem cells versus placebo among participants with chronic obstructive pulmonary disease (COPD).
- Conditions
- COPD, Emphysema or COPD, Chronic Bronchitis
- Trial name
- NCT03228121
- Where
- United States
- Sponsor
- Lung Institute