Clinical trials: Treatment naïve
Hepatitis C, Chronic
Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) versus treatment with peg-IFN and RBV alone in…
- Trial name
- NCT01370642
- Testing
- vaniprevir, Peg-IFN, ribavirin
- Volunteers
- 294 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
ANNAPURNA: A Study of The Combination of RO5466731, RO5190591, Ritonavir and Copegus (Ribavirin) With or Without RO5024048 in Patients With Chronic Hepatitis C Who Are Either Treatment-Naïve or Have Previously Experienced a Null Response to Interferon-Based Treatment
This randomized, open-label, multicenter study will evaluate the safety , efficacy and tolerability of the combination treatment RO5466731, RO5190591, ritonavir and Copegus (ribavirin) with or without RO5024048 in patients with…
- Trial name
- NCT01628094
- Testing
- RO5024048, RO5190591, RO5466731
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 110 people
- Sponsor
- Hoffmann-La Roche
HIV Infections
A Clinical Trial of GSK3640254 + Dolutegravir (DTG) in Human Immunodeficiency Virus-1 Infected Treatment-naive Adults
The purpose of this study was to evaluate the efficacy of GSK3640254 + DTG relative to lamivudine (3TC) + DTG in treatment-naïve adult participants living with human immunodeficiency virus (HIV)-1.
- Trial name
- DYNAMIC (NCT04900038)
- Testing
- GSK3640254, Dolutegravir, Lamivudine capsules
- Where
- 44 sites in United States, Argentina and 8 more
- Volunteers
- 85 people
- Sponsor
- ViiV Healthcare
NSCLC
A Survival Study for Women With Advanced Lung Cancer Who Have Not Previously Received Chemotherapy.
This is a randomized, open-label, multinational, phase III study in women with histologically- or cytologically-confirmed advanced NSCLC who are chemotherapy naïve and have PS 2.
- Trial name
- PIONEER (NCT00269828)
- Testing
- paclitaxel, paclitaxel poliglumex
- Where
- 143 sites in United States, Argentina and 9 more
- Volunteers
- 600 people
- Sponsor
- CTI BioPharma
Diabetes, Diabetes Mellitus, Type 2
Observational Study on Safety of Self-titration of Once Daily Levemir®
This study is conducted in Europe. The main objective of the study is to assess the safety of self-titration in type 2 diabetic patients on antidiabetic tablets who are receiving insulin for the first time.
- Trial name
- SOLVE™ (NCT00740519)
- Testing
- insulin detemir
- Where
- United Kingdom
- Volunteers
- 882 people
- Sponsor
- Novo Nordisk A/S
Hepatitis C
A Study to Evaluate the Efficacy, Safety and Tolerability of TMC435 in Combination With PegIFN Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve or Treatment-Experienced, Chronic Hepatitis C Virus Genotype-4 Infected Patients
The purpose of this study to evaluate the efficacy, safety and tolerability of TMC435 in combination with Peginterferon alfa-2a (PegINF alfa-2a) and ribavirin (RBV) in both treatment-naïve and treatment experienced, chronic…
- Trial name
- RESTORE (NCT01567735)
- Testing
- TMC435
- Where
- 8 sites in Belgium, France
- Volunteers
- 107 people
- Sponsor
- Janssen R&D Ireland
Hypophosphatasia
Phase 3 Study of ALXN1850 in Treatment-Naïve Pediatric Participants With HPP
The primary purpose of this study is to evaluate the efficacy of ALXN1850 versus placebo on radiographic outcomes in pediatric participants with HPP who have not previously been treated with asfotase alfa.
- Trial name
- MULBERRY (NCT06079359)
- Testing
- ALXN1850
- Where
- 32 sites in United States, Australia and 14 more
- Volunteers
- 30 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hepatitis C
Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1
This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC), each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American participants who have never received…
- Trial name
- NCT01446250
- Testing
- Alisporivir, Boceprevir, Peginterferon alfa-2a
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Debiopharm International SA
Hypertension
Observational Cohort Study Evaluating the Effectiveness of an Educational Program (NGAYDAUTIEN) in Combination With Perindopril and Amlodipine Single-Pill Combination in Hypertensive Patients naïve of Antihypertensive Treatments.
The primary objective is to assess the change of systolic blood pressure from baseline after a 6-month follow up for hypertensive patients initiating Viacoram® plus an educational program (NGAYDAUTIEN) in comparison to…
- Trial name
- EDUHYPER (NCT06704815)
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Servier Affaires Médicales
Hepatocellular Carinoma
A Phase 2a Study of Modified Vaccinia Virus to Treat Sorafenib-naïve Advanced Liver Cancer
This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with sorafenib, and the safe administration of JX-594 in…
- Trial name
- FLASH (NCT01636284)
- Testing
- JX-594 recombinant vaccina GM-CSF
- Where
- 5 sites in United States, South Korea and 1 more
- Volunteers
- 16 people
- Sponsor
- Jennerex Biotherapeutics
Psoriatic Arthritis
Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis
Psoriatic arthritis (PsA) is a long-term inflammatory disease that affects the joints and skin. The purpose of this study is to check how safe zasocitinib is, how well it is tolerated and how well it works in adults with PsA over…
- Trial name
- NCT07286058
- Testing
- Zasocitinib
- Where
- 78 sites in United States, Australia and 14 more
- Volunteers
- 1,182 people
- Sponsor
- Takeda
Hepatitis C, Chronic
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.
This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC…
- Trial name
- NCT00377182
- Testing
- Copegus, PEGASYS, RO5024048 1500mg
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 107 people
- Sponsor
- Hoffmann-La Roche
HIV Infections
ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression.
This 2 arm study will assess the immunological benefits of adding Fuzeon to an antiretroviral regimen in HIV-infected, Fuzeon-naive patients with a CD4 cell count <250 cells/mm3 and an HIV RNA viral load <400 copies/mL.
- Trial name
- NCT00461266
- Testing
- enfuvirtide [Fuzeon], Antiretroviral therapy
- Where
- 7 sites in Australia
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis C
A Phase 2a, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
The purpose of the study is to determine the safety, pharmacokinetics and efficacy of orally administered VX-135 with ribavirin in treatment naive subjects with chronic hepatitis C infection.
- Trial name
- NCT01790100
- Testing
- VX-135, Ribavirin
- Where
- Moldova
- Volunteers
- 20 people
- Sponsor
- Alios Biopharma Inc.
Diabetes Mellitus, Type 2
Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients
The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period.
- Trial name
- EASIE (NCT00751114)
- Testing
- Insulin Glargine, Sitagliptin, Metformin
- Where
- 17 sites in United States, Austria and 15 more
- Volunteers
- 515 people
- Sponsor
- Sanofi
Non-Small Cell Lung Cancer
LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer
A single-arm, open-label, two-stage multicenter, phase II study. Patients were pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd was continued until the patient experienced unacceptable toxicity that…
- Trial name
- NCT01685138
- Testing
- LDK378
- Where
- 51 sites in United States, Australia and 16 more
- Volunteers
- 124 people
- Sponsor
- Novartis Pharmaceuticals
Non-small Cell Lung Cancer
Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042)
In this study, participants with programmed cell death ligand 1 (PD-L1)-positive non-small cell lung cancer (NSCLC) will be randomized to receive single agent pembrolizumab for up to 35 treatments or standard of care (SOC)…
- Trial name
- NCT02220894
- Testing
- pembrolizumab, carboplatin, paclitaxel
- Volunteers
- 1,274 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
A Randomised Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir (TPV) Plus 100 mg or 200 mg Ritonavir (RTV) p.o. BID in Comparison to 400 mg Lopinavir (LPV) Plus 100 mg RTV p.o. BID in Combination With Standard Background Regimen in ARV Therapy naïve Patients.
Evaluation of safety and efficacy of Tipranavir (TPV) boosted with Ritonavir (RTV) versus an active control arm (Lopinavir / RTV) in antiretroviral (ARV) therapy naïve HIV-1 infected patients
- Trial name
- NCT00144105
- Testing
- TPV500mg/RTV200mgBID, TPV500mg/RTV100mgBID, LPV400mg/RTV100mgBID
- Where
- 81 sites in Argentina, Australia and 13 more
- Volunteers
- 562 people
- Sponsor
- Boehringer Ingelheim
Paroxysmal Nocturnal Hemoglobinuria, PNH
Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adults Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
The primary objective of this study is to evaluate the efficacy of ravulizumab in adult participants with PNH.
- Trial name
- NCT06578949
- Testing
- Ravulizumab
- Where
- 8 sites in China
- Volunteers
- 18 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
HIV-1, HIV Infection
DOR/ISL in Pediatric Participants With HIV-1, <18 Years of Age and ≥ 35 kg
This is a phase 2 study of the pharmacokinetics, safety, and efficacy of oral doravirine/islatravir (100 mg/0.25 mg) [MK-8591A] in pediatric participants with human immunodeficiency virus type 1 (HIV-1) infection who are…
- Trial name
- NCT07862569
- Testing
- DOR/ISL
- Volunteers
- 45 people
- Sponsor
- Merck Sharp & Dohme LLC