Clinical trials: Treatment naïve
Acute Myelogenous Leukemia
Study of MLN4924 Plus Azacitidine in Treatment-naive Participants With Acute Myelogenous Leukemia (AML) Who Are 60 Years or Older
The purpose of this study is to establish the maximum tolerated dose (MTD), and to assess the safety and tolerability of MLN4924 (pevonedistat) in combination with azacitidine in treatment naive participants with AML who were 60…
- Trial name
- NCT01814826
- Testing
- MLN4924, Azacitidine
- Where
- 8 sites in United States
- Volunteers
- 64 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
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-1-infection
A Real-world Study of Lamivudine and Dotiravir Sodium Tablets in the Treatment-naïve HIV-1 Infected Patients
Actual update to the US Department of Health and Human Services treatment guidelines for HIV-1 infection and European AIDS Clinical Society guidelines indicate Dovato(Dolutegravir/lamivudine) as an initial treatment in HIV-naÏve…
- Trial name
- NCT05332470
- Testing
- Lamivudine and Dotiravir Sodium Tablets
- Volunteers
- 200 people
- Sponsor
- Peking Union Medical College Hospital
Hepatitis C Infection
A Multiple Ascending Dose Phase I Study of SB 9200 in Treatment Naïve Adults With Chronic Hepatitis C Infection
The purpose of this study is to compare the safety and tolerability of ascending doses of SB 9200 given for up to 14 days to subjects with chronic Hepatitis C infection.
- Trial name
- NCT01803308
- Testing
- SB9200
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 37 people
- Sponsor
- Syneos Health
Hepatitis C, Chronic
A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis
This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve…
- Trial name
- NCT01483742
- Testing
- RO5024048, danoprevir, peginterferon alfa-2a [Pegasys]
- Where
- 27 sites in United States, Australia and 5 more
- Volunteers
- 43 people
- Sponsor
- Hoffmann-La Roche
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency
This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment…
- Trial name
- NCT02616562
- Testing
- somapacitan, Norditropin® FlexPro® pen
- Where
- 89 sites in United States, Austria and 12 more
- Volunteers
- 76 people
- Sponsor
- Novo Nordisk A/S
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
Hepatitis C, Chronic
A Study of RO5024048 in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C, Genotype 1 or 4
This 6-arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SOC), versus SOC in treatment-naive patients…
- Trial name
- NCT00869661
- Testing
- Copegus, Pegasys, RO5024048
- Where
- 66 sites in United States, Australia and 8 more
- Volunteers
- 413 people
- Sponsor
- Hoffmann-La Roche
HIV Infection
MK-4646 Multiple Dose Trial in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-4646-003)
This study will examine if at least one dose level of MK-4646 can lower HIV-1 viral load in a person's blood by a certain amount.
- Trial name
- NCT07042945
- Testing
- MK-4646
- Where
- 2 sites in Moldova, Romania
- Volunteers
- 15 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.
This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic…
- Trial name
- NCT00107653
- Testing
- Ribavirin, Peginterferon alfa-2a
- Where
- 60 sites in United States, Puerto Rico
- Volunteers
- 569 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C Virus Infection
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis
The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12 weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus (HCV) genotype 1 infected men and women…
- Trial name
- NCT02114177
- Testing
- Simeprevir, Sofosbuvir
- Where
- 40 sites in United States, Canada
- Volunteers
- 310 people
- Sponsor
- Janssen Infectious Diseases BVBA
Primary Immunodeficiency
An Open-label, Multicenter Study to Assess the Pharmacokinetics (PK), Safety, and Tolerability of Subcutaneous IgPro20 in Immunoglobulin (IG) Treatment-naïve Participants With Primary Immunodeficiency (PID)
This is an open-label, multicenter, phase 4 study in IG treatment-naïve participants with PID, conducted in the United States (US), to assess the PK, safety, and tolerability of IgPro20.
- Trial name
- NCT07076446
- Testing
- IgPro
- Where
- 8 sites in United States
- Volunteers
- 8 people
- Sponsor
- CSL Behring
Hepatitis C
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV) infection.
- Trial name
- NCT01910636
- Testing
- Sofosbuvir, RBV
- Where
- 19 sites in Japan
- Volunteers
- 153 people
- Sponsor
- Gilead Sciences
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
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
Pancreatic Cancer, Adenocarcinoma of the Pancreas
Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma
The purpose of this study is to determine if combination treatment with cemiplimab, motixafortide, gemcitabine, and nab-paclitaxel is effective in decreasing the size of the tumor(s), if it will prolong life in patients, and if…
- Conditions
- Pancreatic Cancer, Adenocarcinoma of the Pancreas, Adenocarcinoma
- Trial name
- NCT04543071
- Testing
- Motixafortide, Cemiplimab, Gemcitabine
- Where
- 5 sites in United States
- Volunteers
- 118 people
- Sponsor
- Columbia University
Diabetes Mellitus, Type 2
A Study of Insulin Peglispro (LY2605541) in Participants With Type 2 Diabetes Mellitus
The main purpose of this study is to compare the efficacy and safety of a new basal insulin, insulin peglispro, to insulin glargine in participants with type 2 diabetes mellitus (T2DM).
- Trial name
- NCT02106364
- Testing
- Insulin Peglispro, Insulin Glargine
- Where
- 10 sites in United States
- Sponsor
- Eli Lilly and Company
Diabetes, Diabetes Mellitus, Type 2
Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes
This trial is conducted in Africa, Asia, Europe, Oceania and South America. This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and…
- Trial name
- NCT00469092
- Testing
- biphasic insulin aspart, insulin glargine, metformin
- Where
- 69 sites in Argentina, Austria and 13 more
- Volunteers
- 480 people
- Sponsor
- Novo Nordisk A/S
Hepatitis C
Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074)
This is a study of grazoprevir (MK-5172) + elbasvir (MK-8742) and sofosbuvir (SOF) in treatment-naive participants with chronic hepatitis C (HCV) genotype (GT) 1 or GT3.
- Trial name
- NCT02133131
- Testing
- Grazoprevir/Elbasvir FDC, Sofosbuvir
- Volunteers
- 143 people
- Sponsor
- Merck Sharp & Dohme LLC
Neuroendocrine Tumors
Targeted Alpha-emitter Therapy of PRRT Naïve and Previous PRRT Neuroendocrine Tumor Patients
Multicenter Phase 2 study of 212Pb-DOTAMTATE enrolling adult subjects with positive somatostatin positive neuroendocrine tumors with either no prior history of peptide receptor radionuclide therapy (PRRT naive) or prior history…
- Trial name
- ALPHAMEDIX02 (NCT05153772)
- Testing
- AlphaMedix
- Where
- 4 sites in United States
- Volunteers
- 69 people
- Sponsor
- Orano Med LLC