Clinical trials: Treatment naïve
Pancreatic Neoplasms
A Randomized Phase 2 Study of ARQ 197 Versus Gemcitabine in Treatment-Naïve Patients With Unresectable Locally Advanced or Metastatic Pancreatic Adenocarcinoma
This is a multi-center, open-label randomized phase 2 study designed to assess the progression free survival (PFS) of patients with untreatment and unresectable pancreatic cancer following treatment with either ARQ 197 or…
- Trial name
- NCT00558207
- Testing
- ARQ 197, gemcitabine
- Where
- 6 sites in Poland
- Volunteers
- 43 people
- Sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Infection, Human Immunodeficiency Virus, HIV Infections
Open-label Study of Dolutegravir (DTG) or Efavirenz (EFV) for Human Immunodeficiency Virus (HIV) - Tuberculosis (TB) Co-infection
HIV/Tuberculosis (TB) co-infection have profound effects on the host's immune system. TB is the most common cause of death in patients with HIV worldwide.
- Trial name
- NCT02178592
- Testing
- DTG 50 mg, EFV 600 mg
- Where
- 28 sites in Argentina, Brazil and 5 more
- Volunteers
- 113 people
- Sponsor
- ViiV Healthcare
Hepatitis C, HIV
Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.
This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics, and pharmacokinetics…
- Trial name
- NCT01565889
- Testing
- SOF, EFV/FTC/TDF, EFV
- Where
- Puerto Rico
- Volunteers
- 52 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis C
GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype
This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon…
- Trial name
- NCT01384383
- Testing
- GS-5885, GS-9451, RBV
- Where
- 55 sites in United States, Australia and 2 more
- Volunteers
- 248 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus
Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia
The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3
- Trial name
- MAGNITUDE (NCT01741545)
- Testing
- Pegylated-Interferon-lambda, Ribavirin, Daclatasvir
- Where
- 32 sites in United States, Australia and 6 more
- Volunteers
- 71 people
- Sponsor
- Bristol-Myers Squibb
Carcinoma, Non-Small-Cell Lung
KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in…
- Trial name
- NCT04165070
- Testing
- Pembrolizumab, Carboplatin, Paclitaxel
- Where
- 47 sites in United States, Canada and 8 more
- Volunteers
- 450 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB
A Phase 2 Study to Evaluate Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203)
This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of telacebec (Q203).
- Trial name
- NCT03563599
- Testing
- Telacebec (Q203), Rifafour e-275
- Where
- 2 sites in South Africa
- Volunteers
- 60 people
- Sponsor
- Qurient Co., Ltd.
Spasticity Related to Any Cause Except Cerebral Palsy
A Study to Assess Treatment Outcomes of abobotulinumtoxinA and onabotulinumtoxinA Treatments in Real Life Practice in Toxin-naïve Adult Patients With Limb Spasticity.
The aim of the study is to describe treatment outcomes of abobotulinumtoxinA (aboBoNT-A) and onabotulinumtoxinA (onaBoNT-A) treatments, after one injection of either treatment, in toxin-naïve adult patients with upper and/or…
- Trial name
- NCT04396704
- Where
- United Kingdom
- Volunteers
- 114 people
- Sponsor
- Ipsen
Liposarcoma, Dedifferentiated
Brightline-4: A Study to Test How Well Brigimadlin is Tolerated by People With a Type of Cancer Called Dedifferentiated Liposarcoma
This study is open to adults with a type of cancer called dedifferentiated liposarcoma (DDLPS). They can join the study if their tumours are positive for MDM2.
- Trial name
- NCT06058793
- Testing
- Brigimadlin
- Where
- 56 sites in United States, Argentina and 5 more
- Volunteers
- 138 people
- Sponsor
- Boehringer Ingelheim
Adenocarcinoma of the Prostate
Study With IMC-A12 (Cixutumumab) in Patients Who Have Not Previously Been Treated With Chemotherapy With Metastatic Prostate Cancer
This single arm, multicenter, open-label, Phase II study will enroll chemotherapy-naive participants with metastatic, histologically-confirmed adenocarcinoma of the prostate (stage M1 D2).
- Trial name
- NCT00520481
- Testing
- IMC-A12 (Cixutumumab)
- Where
- 3 sites in United States
- Volunteers
- 41 people
- Sponsor
- Eli Lilly and Company
High-risk Localized Prostate Cancer
A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
Researchers are looking for a better way to treat men who have high-risk localized prostate cancer, which refers to a type of prostate cancer that is still confined to the prostate gland but has certain characteristics that make…
- Trial name
- CHINANEO (NCT07450599)
- Testing
- Darolutamide, ADT
- Where
- 23 sites in China
- Volunteers
- 250 people
- Sponsor
- Bayer
Essential Thrombocythemia
Anagre Cap. in Patients With High-Risk Essential Thrombocythemia
This study is to evaluate the efficacy and safety according to incremental dosing for 8 weeks and duration of administration for 1 year in patients with high-risk essential thrombocythemia.
- Trial name
- NCT03232177
- Testing
- Anagre Cap.
- Where
- 21 sites in South Korea
- Volunteers
- 70 people
- Sponsor
- Yuhan Corporation
Diabetes, Diabetes Mellitus, Type 2
Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment
This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood glucose lowering effect and the safety profile of repaglinide given alone compared to gliclazide given alone in Chinese subjects with…
- Trial name
- NCT01022762
- Testing
- repaglinide, gliclazide
- Where
- China
- Volunteers
- 440 people
- Sponsor
- Novo Nordisk A/S
Metastatic Colorectal Cancer
Trial of FOLF(HA)Iri Versus FOLFIRI in mCRC
Trial design: Phase III, FOLFIRI versus FOLF(HA)iri (the FOLFIRI regimen with "Hyaluronic acid-Irinotecan" or "HA-Irinotecan") regimen. Patients with mCRC (metastatic colorectal cancer), 2nd/3rd line irinotecan naïve.
- Trial name
- FOLF(HA)iri (NCT01290783)
- Testing
- Irintoecan, HA-Irinotecan solution for Infusion
- Where
- 5 sites in Australia
- Volunteers
- 390 people
- Sponsor
- Alchemia Oncology
HIV Infections
Study of Lopinavir, Ritonavir, Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects
The purpose of this study is to compare the safety, tolerability and antiviral activity between once-daily (QD) and twice-daily (BID) dosing of lopinavir/ritonavir and to further characterize the pharmacokinetics of once-daily…
- Trial name
- NCT00043966
- Testing
- Lopinavir/ritonavir, Tenofovir DF, Emtricitabine
- Where
- 52 sites in United States, Australia and 5 more
- Volunteers
- 200 people
- Sponsor
- Abbott
Chronic Hepatitis, Hepatitis B
Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus
The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks and 96 weeks.
- Trial name
- QUASH 1 (NCT00496002)
- Testing
- Clevudine, Adefovir
- Where
- 134 sites in United States, Argentina and 10 more
- Sponsor
- Pharmasset
Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV-MF)
Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis
This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF) The study will be conducted in 2 stages.
- Conditions
- Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV-MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF)
- Trial name
- NCT04878003
- Testing
- KRT-232, TL-895
- Where
- 29 sites in United States, Belarus and 7 more
- Volunteers
- 52 people
- Sponsor
- Kartos Therapeutics, Inc.
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
HIV-1 Infection
Efficacy, Safety, and Tolerability of Cenicriviroc (CVC) in Combination With Truvada or Sustiva Plus Truvada in HIV 1-infected, Antiretroviral Treatment-naïve, Adult Patients Infected With Only CCR5-tropic Virus
This is a randomized, double-blind, double-dummy, 48-week, comparative study. Approximately 150 HIV-infected, treatment-naïve patients with CCR5-tropic virus will be stratified by HIV-1 RNA: ≥100,000 copies/mL versus <100,000…
- Trial name
- NCT01338883
- Testing
- Cenicriviroc 100 mg, Cenicriviroc 200 mg + Truvada, Sustiva + Truvada
- Where
- 48 sites in United States, Puerto Rico
- Volunteers
- 143 people
- Sponsor
- Tobira Therapeutics, Inc.