Clinical trials: Treatment naïve
Chronic Hepatitis B
Comparison of the Efficacy of Entecavir and Tenofovir Monotherapy for the Treatment of Nucleos(t)Ide-naïve Patients With Chronic Hepatitis B in Korea
Chronic hepatitis B virus infection is an important cause of morbidity and mortality. Tenofovir disoproxil fumarate and entecavir were licensed for the treatment of hepatitis B virus infection.
- Trial name
- NCT01776814
- Where
- South Korea
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Gachon University Gil Medical Center
Glioblastoma, Glioma
Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.
A multi-center, open-label, single-arm, phase I/II clinical study is designed to test the safety and immunogenicity of an investigational Dendritic and Glioma Cells Fusion vaccine given with IL-12 for treatment-naïve patients…
- Conditions
- Glioblastoma, Glioma, Neoplasms, Neuroepithelial, Neuroectodermal Tumors
- Trial name
- NCT04388033
- Testing
- Dendritic Cell/Tumor Fusion Vaccine, Interleukin-12, Temozolomide
- Where
- 2 sites in China
- Volunteers
- 10 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Fabry Disease
A Study of Two Fabrazyme (Agalsidase Beta) Dosing Regimens in Treatment-naïve, Male Pediatric Patients Without Severe Symptoms
The purpose of this study was to determine whether 2 alternative dosing regimens of Fabrazyme (Agalsidase beta) (1.0 mg/kg every 4 weeks or 0.5 mg/kg every 2 weeks) were effective in treatment-naïve pediatric participants without…
- Trial name
- FIELD (NCT00701415)
- Testing
- Agalsidase beta
- Where
- 12 sites in United States, Argentina and 7 more
- Volunteers
- 31 people
- Sponsor
- Genzyme, a Sanofi Company
Diabetic Macular Edema
A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.
- Trial name
- GLEAM (NCT04611152)
- Testing
- KSI-301, Aflibercept
- Where
- 75 sites in United States, Germany and 6 more
- Volunteers
- 460 people
- Sponsor
- Kodiak Sciences Inc
Hepatitis C, Chronic
A Study of Ritonavir-Boosted Danoprevir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients of Asian Origin With Chronic Hepatitis C Genotype 1 With or Without Cirrhosis
This Phase II, open-label, parallel-arm study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and Copegus…
- Trial name
- NCT01749150
- Testing
- danoprevir + ritonavir, peginterferon alfa-2a [Pegasys], ribavirin [Copegus]
- Where
- 13 sites in South Korea, Taiwan and 1 more
- Volunteers
- 61 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis C Virus (HCV)
Quality of Life Measurement in Treatment Naïve Patients With Hepatitis C Virus (HCV) Genotype 1 (GT1) Suffering From Fatigue and Receiving Ombitasvir, Paritaprevir, and Ritonavir and Dasabuvir (Viekirax®/Exviera®)
This is an observational, prospective, open-label, single-arm, multicenter, real-life study designed to observe the impact of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (Viekirax®/Exviera®, 3D regimen) on total…
- Trial name
- HEMATITE (NCT03002818)
- Where
- 5 sites in Switzerland
- Volunteers
- 41 people
- Sponsor
- AbbVie
Mucopolysaccharidosis III, Type B (MPS IIIB), Sanfilippo B
A Open Label Study in Previously Studied, SBC-103 Treatment Naïve MPS IIIB Subjects to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics/Efficacy of SBC-103 Administered Intravenously
This study evaluated the safety and tolerability of intravenous (IV) administration of SBC-103 in previously studied, SBC-103 treatment naïve patients with mucopolysaccharidosis III, type B (MPS IIIB, Sanfilippo B) who…
- Trial name
- CL01-T (NCT02618512)
- Testing
- SBC-103
- Where
- United Kingdom
- Volunteers
- 3 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hepatitis B, Chronic
A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
The purpose of this study is to determine whether ARC-520 in combination with entecavir is effective in the treatment of patients with chronic HBV Infection.
- Trial name
- NCT02065336
- Testing
- ARC-520, entecavir, chlorpheniramine
- Where
- 2 sites in Hong Kong
- Volunteers
- 58 people
- Sponsor
- Arrowhead Pharmaceuticals
Acute Myelogenous Leukemia, AML
A Study Evaluating Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Participants With Acute Myelogenous Leukemia
This study consists of two parts: A Phase 1 dose-escalation part that will evaluate the safety and pharmacokinetic profile of venetoclax in combination with low-dose cytarabine (LDAC), define the maximum tolerated dose (MTD), and…
- Trial name
- NCT02287233
- Testing
- Venetoclax, Cytarabine
- Where
- 9 sites in United States, Australia and 2 more
- Volunteers
- 94 people
- Sponsor
- AbbVie
Myelofibrosis, Myelofibrosis Due to and Following Polycythemia Vera
Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis
The goal of this clinical trial is to learn which of three different doses of Flonoltinib Maleate taken by mouth daily works best to treat adult patients with myelofibrosis in whom the most common approved therapy has failed to…
- Conditions
- Myelofibrosis, Myelofibrosis Due to and Following Polycythemia Vera, Myelofibrosis Transformation in Essential Thrombocythemia, Myelofibrosis With High Molecular Risk Mutations
- Trial name
- FM-MF-02 (NCT07750574)
- Testing
- Flonoltinib Maleate orally
- Volunteers
- 105 people
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
HIV-1 Infection
Impact of Starting a Dolutegravir-based Regimen on HIV-1 Proviral DNA Reservoir Of Treatment Naïve and Experienced Patients
This is a multi-center prospective study. The primary objective of DRONE study is to investigate the change of the size of HIV-1 DNA reservoir in blood from baseline to week 48 (W48) in participants treated by DTG-based regimen.
- Trial name
- DRONE (NCT02370979)
- Testing
- Blood samples
- Where
- 4 sites in France
- Volunteers
- 202 people
- Sponsor
- University Hospital, Strasbourg, France
Diabetes, Diabetes Mellitus, Type 2
Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin
This trial is conducted in Asia, Europe, Oceania and South America. The aim of this clinical trial is to generate data demonstrating how to intensify diabetes treatment using BIAsp 30 (biphasic insulin aspart 30) by adding or…
- Trial name
- SIT2MIX (NCT01519674)
- Testing
- biphasic insulin aspart 30, sitagliptin, metformin
- Where
- 69 sites in Argentina, Australia and 8 more
- Volunteers
- 582 people
- Sponsor
- Novo Nordisk A/S
Metastatic Urothelial Carcinoma, Urothelial Carcinoma
N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer
This phase Ib trial will investigate the effect of N-803 in combination with pembrolizumab and enfortumab vedotin in treating participants with urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced)…
- Conditions
- Metastatic Urothelial Carcinoma, Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Urothelial Cancer
- Trial name
- NCT07217496
- Testing
- Nogapendekin Alfa Inbakicept (NAI), enfortumab vedotin (EV), Pembrolizumab
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- ImmunityBio, Inc.
Extensive Small Cell Lung Cancer
A Phase II Clinical Study of Cadonilimab in Treatment-naïve or Relapsed Extensive Small Cell Lung Cancer
Small cell lung cancer (SCLC) accounts for 15% of lung cancer cases and is an aggressive cancer characterized by rapid growth, early metastasis, and a poor prognosis.
- Trial name
- NCT06406673
- Testing
- Cadonilimab+EC/ET+RT, Cadonilimab+vorolanib
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Henan Cancer Hospital
Non-Small Cell Lung Cancer
Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study was to see how well three investigational drugs worked together in preventing progression of the disease.
- Trial name
- NCT00356122
- Testing
- Docetaxel, Oxaliplatin, Bevacizumab
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Sanofi
Hepatitis C
Observational Study of Patients With Chronic Hepatitis C Virus (HCV) Infected With HCV Genotype 1 Low Virus Load (LVL 1) and Effect of PegIntron Plus Rebetol Treatment (Study P04793 Part 2)
The purpose of this observational study was to provide summary data from participants who relapsed at the end of the follow-up phase after 24 weeks of treatment with standard care PegIntron plus ribavirin in Part 1 of the study…
- Trial name
- NCT01054742
- Testing
- Standard of Care PegIntron, Standard of Care Ribavirin
- Volunteers
- 2 people
- Sponsor
- Merck Sharp & Dohme LLC
Myelodysplastic Syndrome
Birinapant With 5-azacitidine in MDS Subjects Who Are Naïve, Have Relapsed or Are Refractory to 5-azacitidine Therapy
This is a dose escalation followed by dose expansion study of TL32711 in combination with 5-Azacitidine in subjects with Myelodysplastic syndrome who are naïve, have relapsed or have failed prior 5-azacitidine therapy.
- Trial name
- NCT01828346
- Testing
- Birinapant, 5-Azacitidine
- Where
- 7 sites in United States
- Volunteers
- 21 people
- Sponsor
- TetraLogic Pharmaceuticals
Acquired Immunodeficiency Syndrome, HIV Infections
Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naive and…
- Trial name
- NCT01440569
- Testing
- COBI, DRV, NRTIs
- Where
- 49 sites in United States, Puerto Rico
- Volunteers
- 314 people
- Sponsor
- Gilead Sciences
Carcinoma, Renal Cell
Patient Preference Study of Pazopanib Versus Sunitinib in Advanced or Metastatic Kidney Cancer
This is a randomised, double-blind, cross-over study of pazopanib versus sunitinib in patients with locally advanced or metastatic renal cell carcinoma (mRCC) who have received no prior systemic therapy for advanced or metastatic…
- Trial name
- PISCES (NCT01064310)
- Testing
- pazopanib, sunitinib
- Where
- 51 sites in Finland, France and 3 more
- Volunteers
- 169 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis B, Chronic
A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects
This is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled study evaluating the safety, efficacy, and pharmacokinetics (PK) of AL-3778 in combination with Peg-IFN in subjects with Hepatitis B e antigen (HBeAg)…
- Trial name
- NCT03125213
- Testing
- AL-3778, Peginterferon Alfa-2A
- Sponsor
- Alios Biopharma Inc.