Clinical trials: Treatment naïve
Multiple Sclerosis, Relapsing-Remitting, Relapsing-Remitting Multiple Sclerosis
Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)
The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) as their…
- Trial name
- IMPROVE (NCT02323269)
- Testing
- dimethyl fumarate
- Where
- 10 sites in Canada
- Volunteers
- 24 people
- Sponsor
- Biogen
HIV-1 Infection
Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ≥35 kg (MK-8591A-028)
This is a phase 2, single-group, multi-site, open-label study of an islatravir/doravirine (ISL/DOR, MK-8591A) fixed dose combination (FDC) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric…
- Trial name
- NCT04295772
- Testing
- DOR/ISL
- Where
- 17 sites in United States, Italy and 3 more
- Volunteers
- 42 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV-1 Infection
Activity of MK-8504 in Anti-retroviral-naïve, Human Immunodeficiency Virus 1 (HIV-1) Infected Participants (MK-8504-002)
This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-retroviral therapy (ART) activity of monotherapy with MK-8504 (a tenofovir pro-drug), in ART-naïve Human Immunodeficiency Virus (HIV)-1…
- Trial name
- NCT03188523
- Testing
- MK-8504
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 12 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C
Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants
This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy [i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)] to optimize treatment in treatment-naïve participants with hepatitis…
- Trial name
- NCT01318694
- Testing
- Alisporivir, Peginterferon alfa-2a, Ribavirin
- Where
- 146 sites in United States, Argentina and 19 more
- Volunteers
- 1,081 people
- Sponsor
- Debiopharm International SA
Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic
A Study of LY01008 and Bevacizumab Combined With Paclitaxel and Carboplatin for Treatment of Naïve Subjects With Metastatic or Recurrent Nonsquamous Non-small Cell Lung Cancer
This is a Randomized, Double-blind, Multicenter Phase III Study Comparing Efficacy and Safety of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Bevacizumab Combined…
- Conditions
- Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Recurrent
- Trial name
- NCT03533127
- Testing
- LY01008, Bevacizumab
- Where
- China
- Volunteers
- 648 people
- Sponsor
- Luye Pharma Group Ltd.
Diabetes Mellitus Type 2
A Study to Compare Taspoglutide and Insulin Glargine in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea Combination Therapy
This randomized, open-label, parallel arm study will compare the safety, tolerability and effect on glycemic control of taspoglutide versus insulin glargine in insulin-naïve patients with type 2 diabetes mellitus inadequately…
- Trial name
- NCT01051011
- Testing
- insulin glargine, metformin, taspoglutide
- Where
- 56 sites in China, Hong Kong and 5 more
- Volunteers
- 370 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Chronic
ACCELERATE Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC) Infection.
This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy.
- Trial name
- NCT00077636
- Testing
- Copegus, peginterferon alfa-2a [Pegasys]
- Where
- 132 sites in United States, Australia and 7 more
- Volunteers
- 1,469 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis c
Trial Comparing the Efficacy, Tolerability and Safety Between Three Arms in Treatment of HCV in Egyptian Population
A single Center, Prospective Phase IV, Open-Label, Controlled, Randomized Trial comparing the efficacy, safety, and tolerability of Quadritherapy regimen (Reiferon Retard® , Ribavirin , Nitazoxanide and Alfacalcidol (Bon-One ® )…
- Trial name
- Quadritherapy (NCT01896609)
- Testing
- Reiferon Retard in Arm 1, Bon one in Arm 3, Xerovirinc in Arm 2
- Where
- Egypt
- Volunteers
- 300 people
- Sponsor
- MinaPharm Pharmaceuticals
Glycogen Storage Disease Type II;Pompe's Disease
Study to Compare the Efficacy and Safety of Enzyme Replacement Therapies Avalglucosidase Alfa and Alglucosidase Alfa Administered Every Other Week in Patients With Late-onset Pompe Disease Who Have Not Been Previously Treated for Pompe Disease
Primary Objective: To determine the effect of avalglucosidase alfa treatment on respiratory muscle strength measured by percent (%) predicted forced vital capacity (FVC) in the upright position, as compared to alglucosidase alfa.
- Trial name
- COMET (NCT02782741)
- Testing
- Avalglucosidase alfa (GZ402666), Alglucosidase alfa (GZ419829)
- Where
- 69 sites in United States, Argentina and 23 more
- Volunteers
- 101 people
- Sponsor
- Genzyme, a Sanofi Company
Colorectal Cancer
A Study of Capecitabine (Xeloda) in Patients With Metastatic Colorectal Cancer
This study will evaluate the efficacy, safety, and pharmacoeconomics of oral capecitabine in patients with metastatic colorectal cancer.
- Trial name
- NCT02567331
- Testing
- Capecitabine
- Where
- 5 sites in Bulgaria
- Volunteers
- 28 people
- Sponsor
- Hoffmann-La Roche
HIV-1
A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care
The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of care in newly diagnosed human…
- Trial name
- NCT03227861
- Testing
- DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
- Where
- 16 sites in United States
- Volunteers
- 109 people
- Sponsor
- Janssen Scientific Affairs, LLC
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS-2-US-c)
This is an open-label extension study of another study protocol, MCS-2-US-a. Subjects who have completed the 12-week treatment and procedures under the protocol MCS-2-US-a will be eligible for this study.
- Trial name
- MCS-2-US-c (NCT01002222)
- Testing
- MCS-2
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Health Ever Bio-Tech Co., Ltd.
Diabetes Mellitus, Type 2
Efficacy and Safety Study of Linagliptin (5 mg Administered Orally Once Daily) Over 24 Weeks, in Drug naïve or Previously Treated Type 2 Diabetic Patients With Insufficient Glycaemic Control
In this randomised, double-blind, parallel group trial, the safety and efficacy of 5 mg of Linagliptin administered orally once daily will be compared with a placebo after 24 weeks of treatment in monotherapy in patients with…
- Trial name
- NCT01214239
- Testing
- Linagliptin
- Where
- 19 sites in China, Malaysia and 1 more
- Volunteers
- 300 people
- Sponsor
- Boehringer Ingelheim
Relapsed/Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20).
- Conditions
- Relapsed/Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Richter's Syndrome, Treatment-naïve High Risk Chronic Lymphocytic Leukemia
- Trial name
- EPCORE™ CLL-1 (NCT04623541)
- Testing
- Epcoritamab, rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone, Venetoclax
- Where
- 81 sites in United States, Australia and 10 more
- Volunteers
- 194 people
- Sponsor
- Genmab
Chronic HCV Infection
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants…
- Trial name
- NCT02021656
- Testing
- LDV/SOF
- Where
- 45 sites in China, South Korea and 1 more
- Volunteers
- 384 people
- Sponsor
- Gilead Sciences
Glioblastoma, Gliosarcoma
ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme
This phase II clinical trial studies how well ERC1671 plus Granulocyte-macrophage colony-stimulating factor (GM-CSF) plus Cyclophosphamide with Bevacizumab works compared to Placebo Injection plus Placebo Pill with Bevacizumab in…
- Trial name
- NCT01903330
- Testing
- ERC1671, GM-CSF, Cyclophosphamide
- Where
- 3 sites in United States
- Volunteers
- 84 people
- Sponsor
- Epitopoietic Research Corporation
Small Cell Lung Cancer
Phase Ib/II Study of M3814 With Etoposide and Cisplatin in Small Cell Lung Cancer (SCLC) Extensive Disease (ED)
M3814 is an investigational drug under evaluation for treatment of lung cancer. The purpose of the study was to assess the Safety and Efficacy of M3814 in combination with chemotherapy with SCLC ED.
- Trial name
- NCT03116971
- Testing
- M3814, Cisplatin, Etoposide
- Where
- 80 sites in United States, Belgium and 11 more
- Volunteers
- 2 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Colorectal Cancer
An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Efficacy and Safety Study of mFOLFOX6 + Bevacizumab Versus mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy-naïve Unresectable Advanced or Recurrent Colorectal Cancer
The purpose of this study is to investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable…
- Trial name
- NCT02394834
- Testing
- oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab, oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab
- Where
- 151 sites in Japan
- Volunteers
- 757 people
- Sponsor
- Takeda
HIV-1 Infection
Renal Effect of Stribild or Other Tenofovir DF-containing Regimens Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naive HIV-1 Infected Adults
The primary objective of this study is to assess glomerular function before and during administration of stribild (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) or a regimen containing TDF…
- Trial name
- NCT02246998
- Testing
- STB, TVD, ATR
- Where
- 20 sites in Belgium, France and 3 more
- Volunteers
- 72 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
Grazoprevir (MK-5172) Administered With Peginterferon and Ribavirin in Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-003)
This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered in combination with peginterferon alfa-2b (Peg-IFN) and ribavirin (RBV) in treatment-naïve (TN) participants…
- Trial name
- NCT01353911
- Testing
- Grazoprevir, Boceprevir, Peg-interferon alfa-2b
- Volunteers
- 368 people
- Sponsor
- Merck Sharp & Dohme LLC