Clinical trials: Treatment naïve
Chronic Hepatitis C, CHC
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Subjects With Genotype 1 Chronic Hepatitis C Chronic Hepatitis C
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C
- Conditions
- Chronic Hepatitis C, CHC, HCV, Hepatitis C
- Trial name
- NCT01842451
- Testing
- VX-135, Daclatasvir
- Where
- 2 sites in New Zealand
- Volunteers
- 23 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
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
Non-Hodgkin Lymphoma
Comparing Interleukin-2 (IL-2) Combined With Rituximab (Rituxan) to Rituximab Alone in Subjects With Non-Hodgkin's Lymphoma (NHL)
The purpose of this study is to determine whether interleukin-2 given 3 times weekly for 8 weeks in combination with rituximab is effective and safe when compared to rituximab given alone in the treatment of follicular NHL…
- Trial name
- NCT00100737
- Testing
- interleukin-2, rituximab
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Chiron Corporation
Hepatitis C Virus
Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients
Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for…
- Trial name
- NCT01188772
- Testing
- Sofosbuvir, PEG, RBV
- Where
- 23 sites in United States, Puerto Rico
- Volunteers
- 147 people
- Sponsor
- Gilead Sciences
Non-Small Cell Lung Cancer, Lung Cancer, Non-Small Cell
Pazopanib As Pre-Surgical Therapy In Treatment-Naive Subjects With Non-Small Cell Lung Cancer
This is a phase 2 open-label, multicenter, non-randomized study to evaluate the safety and efficacy of oral pazopanib as neoadjuvant treatment for patients with stage 1A, 1B, IIA or IIB (to T2) resectable Non-Small Cell Lung…
- Trial name
- NCT00367679
- Testing
- Pazopanib
- Where
- 12 sites in United States, Israel and 1 more
- Volunteers
- 35 people
- Sponsor
- GlaxoSmithKline
Prostatic Neoplasms
Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms
To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs…
- Trial name
- ERA 223 (NCT02043678)
- Testing
- Radium-223 dichloride (Xofigo, BAY88-8223), Abiraterone, Prednisone/Prednisolone
- Where
- 163 sites in United States, Australia and 17 more
- Volunteers
- 806 people
- Sponsor
- Bayer
Multiple Sclerosis
Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy Volunteers
This study will look at differences in bioanalytical measures among different groups of MS patients and Healthy Volunteers, when administered interferon beta-1a.
- Trial name
- NCT00913666
- Testing
- Interferon beta-1a (Avonex)
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Biogen
Glioma, Glioblastoma
Study of VAL-083 in Patients With MGMT Unmethylated, Bevacizumab-naive Glioblastoma in the Adjuvant or Recurrent Setting
The purpose of this phase 2, two arm, biomarker-driven study is to determine if treatment of O-6-methylguanine-DNA methyltransferase (MGMT) unmethylated glioblastoma with VAL-083 improves overall survival (OS), compared to…
- Conditions
- Glioma, Glioblastoma, Glioblastoma Multiforme, GBM
- Trial name
- NCT02717962
- Testing
- VAL-083, Dianhydrogalactitol
- Where
- United States
- Volunteers
- 118 people
- Sponsor
- Kintara Therapeutics, Inc.
Carcinoma, Non-Small-Cell Lung
KEYMAKER-U01 Substudy 2: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Treatment-naïve Participants With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Positive Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01B/KEYMAKER-U01B)
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) in combination with MK-4830 in treatment-naïve participants with advanced squamous or non-squamous NSCLC that is PD-L1 positive.
- Trial name
- NCT04165083
- Testing
- Pembrolizumab, MK-4830, MK-0482
- Where
- 39 sites in United States, Hungary and 5 more
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
Rheumatoid Diseases, Rheumatoid Arthritis
Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Rheumatoid Diseases Who Are Naïve To Biologics Or Switched From Remicade
To assess persistence of CT-P13 in patients with Rheumatoid Diseases (Rheumatoid arthritis [RA], ankylosing spondylitis [AS], and psoriatic arthritis [PsA]) who are naïve to biologics or are switching from stable Remicade to…
- Conditions
- Rheumatoid Diseases, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
- Trial name
- PERSIST (NCT02605642)
- Testing
- CT-P13
- Where
- 38 sites in Bulgaria, Canada and 5 more
- Volunteers
- 351 people
- Sponsor
- Pfizer
HIV-1
Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018)
To establish a new treatment option for treatment-naïve participants with HIV-1, the efficacy and safety of doravirine will be determined relative to a protease inhibitor (PI).
- Trial name
- DRIVE-FORWARD (NCT02275780)
- Testing
- Doravirine, Darunavir, Ritonavir
- Volunteers
- 769 people
- Sponsor
- Merck Sharp & Dohme LLC
Rheumatoid Arthritis
A Safety & Efficacy Study of Treatment With AP1189 in Rheumatoid Arthritis Patients naïve to DMARD Treatment
The study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of 12 weeks daily treatment with 100 mg AP1189 in RA patients who are to start up-titration with methotrexate…
- Trial name
- EXPAND (NCT05516979)
- Testing
- 100 mg AP1189
- Where
- Moldova
- Volunteers
- 127 people
- Sponsor
- SynAct Pharma Aps
Small Cell Lung Cancer
Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)
Researchers are looking for new ways to treat Limited-Stage Small Cell Lung Cancer (LS-SCLC), a type of lung cancer that has not spread from the lung to other parts of the body.
- Trial name
- NCT04624204
- Testing
- Pembrolizumab 200 mg, Pembrolizumab 400 mg, Olaparib 300 mg BID
- Where
- 187 sites in United States, Australia and 23 more
- Volunteers
- 672 people
- Sponsor
- Merck Sharp & Dohme LLC
Acromegaly
Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients
Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly.
- Trial name
- NCT00128232
- Testing
- Octreotide LAR
- Volunteers
- 100 people
- Sponsor
- Novartis
Hepatitis C, Chronic
An Observational Study of Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) on Predictive Values of RVR on Sustained Virological Response in Different Stages of Liver Fibrosis in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1
This observational study will evaluate the predictive value of rapid virological response (RVR) and early virological response (EVR) on sustained virological response (SVR) by stage of liver fibrosis in treatment-naïve patients…
- Trial name
- NCT01750216
- Where
- 14 sites in Poland
- Volunteers
- 196 people
- Sponsor
- Hoffmann-La Roche
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
Non-Hodgkin's Lymphoma
A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
This study will evaluate the efficacy and safety of brief induction therapy with a chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with MabThera or no further therapy.
- Trial name
- NCT01144364
- Testing
- rituximab [Mabthera/Rituxan]
- Where
- 45 sites in Italy
- Volunteers
- 234 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Liver Disease
Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
This study will explore the relationship of different DEB025 doses in combination with RBV to pharmacokinetic, pharmacodynamic (i.e.
- Trial name
- NCT01970904
- Testing
- Alisporivir, Ribavirin, Peg-IFNα2a
- Where
- 25 sites in Germany, Poland and 2 more
- Volunteers
- 147 people
- Sponsor
- Debiopharm International SA
Neoplasm Metastasis, Advanced Tumors
Platform Trial Evaluating Safety and Efficacy of Ezabenlimab Anti- PD-1 Based Combination Therapies in PD-(L)1 naïve and PD- (L)1 Pretreated Patient Populations With Advanced/Metastatic Solid Tumours
This is a study in adults with various types of advanced cancer. The purpose of the study is to test a medicine called BI 754091 in combination with several other cancer medicines. BI 754091 is an immunotherapy.
- Conditions
- Neoplasm Metastasis, Advanced Tumors, Metastatic Solid Tumors
- Trial name
- NCT03697304
- Testing
- Ezabenlimab, BI 754111, BI 836880
- Where
- 17 sites in United States, Canada and 1 more
- Volunteers
- 211 people
- Sponsor
- Boehringer Ingelheim
Pain
Clinical Usefulness and Quality of Life of OROS Hydromorphone in Patients Who Have Not Been Treated With a Strong Opioid
The primary purpose of this study is to evaluate the usefulness of hydromorphone to treat cancer pain in patients who have not been treated with a strong opioid.
- Trial name
- NCT01532895
- Testing
- Hydromorphone HCI OROS
- Where
- 11 sites in South Korea
- Volunteers
- 400 people
- Sponsor
- Janssen Korea, Ltd., Korea