Clinical trials: Treatment naïve
Paroxysmal Nocturnal Hemoglobinuria (PNH)
ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who had never been treated with a complement inhibitor (treatment-naïve).
- Trial name
- NCT02946463
- Testing
- Ravulizumab, Eculizumab
- Where
- 120 sites in United States, Argentina and 24 more
- Volunteers
- 272 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Tuberculosis, HIV
Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment
This will be a Phase IIIb Clinical Trial, an international multicenter, randomized, three-arm, non-comparative trial of efficacy, safety, and tolerability of the dual therapy regimen dolutegravir plus lamivudine either twice…
- Trial name
- DOVETAIL (NCT06497465)
- Testing
- Dolutegravir 50mg Tab, Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO], Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)
- Where
- 5 sites in Brazil
- Volunteers
- 150 people
- Sponsor
- Johns Hopkins University
Gastric Cancer
A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
This study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy…
- Trial name
- NCT06256328
- Testing
- ONO-4578, Oxaliplatin, Capecitabine
- Where
- 63 sites in Japan, South Korea and 1 more
- Volunteers
- 226 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Lung Non-Small Cell Squamous Carcinoma, Stage IV Lung Cancer AJCC v8
Testing the Addition of an Anti-cancer Drug, Berzosertib (M6620, VX-970), to the Usual Treatments (Carboplatin and Gemcitabine) and to Pembrolizumab for Patients With Advanced Squamous Cell Non-small Cell Lung Cancer
This phase Ib/II trial studies the best dose of carboplatin when given together with berzosertib, gemcitabine and pembrolizumab and to see how well it works in treating patients with stage IV squamous cell non-small cell lung…
- Trial name
- NCT04216316
- Testing
- Berzosertib, Biospecimen Collection, Carboplatin
- Where
- 34 sites in United States
- Volunteers
- 12 people
- Sponsor
- National Cancer Institute (NCI)
Mucopolysaccharidosis (MPS), Hunter Syndrome
A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II)
The main aim of this study is to evaluate the ability of a prophylactic immune tolerizing regimen (ITR) to prevent or reduce the development of high titer anti-idursulfase antibodies in treatment-naïve participants with Hunter…
- Trial name
- NCT05494593
- Testing
- ELAPRASE, Rituximab, Methotrexate
- Where
- 8 sites in United States
- Sponsor
- Takeda
Gastric Cancer, Gastroesophageal Junction Cancer
Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
This is a Phase 2/3, randomized, open-label study for the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer conducted in two parts.
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer, HER2-positive Gastric Cancer
- Trial name
- MAHOGANY (NCT04082364)
- Testing
- margetuximab, Retifanlimab, Tebotelimab
- Where
- 73 sites in United States, China and 7 more
- Volunteers
- 82 people
- Sponsor
- MacroGenics
Bone Demineralization
Alendronate for Prevention of AntiRetroviral Therapy-associated Bone Loss
Antiretroviral therapy (ART) initiation is associated with a significant loss of bone mineral density (BMD), characterised by increases in bone turnover, which is largely limited to the first 48 weeks of therapy.
- Trial name
- APART (NCT02322099)
- Testing
- Alendronate, calcium carbonate and colecalciferol, Tenofovir disoproxil
- Where
- 2 sites in Ireland
- Volunteers
- 53 people
- Sponsor
- University College Dublin
Non-Hodgkin's Lymphoma
A Study of Induction and Maintenance Treatment With MabThera (Rituximab) in Patients With Indolent B-Cell Nonfollicular Lymphomas
This study will evaluate the efficacy and safety of MabThera in combination chemotherapy, followed by maintenance treatment with MabThera.
- Trial name
- NCT01153971
- Testing
- rituximab
- Where
- 15 sites in Italy
- Volunteers
- 47 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis C Infection
Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection
This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2 (SS2) will be open label and enroll subjects…
- Trial name
- GIFT I (NCT02023099)
- Testing
- ABT-450/r/ABT-267
- Volunteers
- 363 people
- Sponsor
- AbbVie
Fabry Disease
Evaluation of the Long-term Safety, Pharmacodynamics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-Naïve Adult Male Patients With Fabry Disease
Primary Objective: To assess the long-term safety of GZ/SAR402671 in adult male participants with Fabry disease who previously completed study ACT13739 (NCT02489344).
- Trial name
- NCT02489344
- Testing
- GZ/SAR402671
- Where
- 7 sites in United States, France and 3 more
- Volunteers
- 8 people
- Sponsor
- Genzyme, a Sanofi Company
Acute Myeloid Leukemia (AML), Cancer
A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
A study evaluating the effectiveness and safety of venetoclax, in combination with azacitidine or decitabine, in an outpatient setting for treatment-naïve participants with AML who are ineligible for intensive chemotherapy.
- Trial name
- NCT03941964
- Testing
- Venetoclax, Azacitidine, Decitabine
- Where
- 16 sites in United States
- Volunteers
- 60 people
- Sponsor
- AbbVie
Lung Cancer
Osimertinib Plus Bevacizumab in Untreated EGFR Exon21 L858R Mutated NSCLC
This is a prospective, multicenter, randomized, open label study to investigate the efficacy and safety of osimertinib plus bevacizumab versus osimertinib montherapy in treatment-naïve recurrent or metastatic NSCLC patients…
- Trial name
- NCT04988607
- Testing
- Osimertinib, Bevacizumab
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Guangdong Association of Clinical Trials
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus…
- Trial name
- NCT02413593
- Testing
- LDV/SOF, RBV
- Where
- 15 sites in Canada
- Volunteers
- 111 people
- Sponsor
- Gilead Sciences
Non-Small Cell Lung Cancer
Phase II Study Investigating the Combination of Encorafenib and Binimetinib in BRAF V600E Mutated Chinese Patients With Metastatic Non-Small Cell Lung Cancer
This is a phase 2, multicenter, single-arm study with a safety lead-in to investigate the efficacy, safety and pharmacokinetics of encorafenib 450 mg once daily (QD) in combination with binimetinib 45 mg twice daily (BID)…
- Trial name
- OCEANII (NCT05195632)
- Testing
- Encorafenib, Binimetinib
- Where
- 34 sites in China, Taiwan
- Volunteers
- 63 people
- Sponsor
- Pierre Fabre Medicament
Hepatitis C
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and…
- Trial name
- D-LITE (NCT01309932)
- Testing
- Pegylated Interferon Lambda (pegIFNλ), BMS-790052 (NS5A Inhibitor), Ribavirin (RBV)
- Where
- 40 sites in United States, Australia and 7 more
- Volunteers
- 165 people
- Sponsor
- Bristol-Myers Squibb
HIV Positive
Bone, Inflammation, Gut and Renal Biomarkers in Antiretroviral Naïve HIV-1 Positive Subjects
Co-morbidities, including low bone mineral density, increased visceral adiposity and chronic kidney disease (CKD) are frequent in people living with HIV, and may be driven by ongoing inflammation and immune activation.
- Trial name
- BIGGER (NCT03660722)
- Testing
- blood and urinary samples
- Where
- France
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Chronic Hepatitis B
Residual Histological Disease Across Treatment Pathways in Chronic Hepatitis B
This retrospective, two-center observational study evaluates contemporary non-biopsy treatment pathways in treatment-naïve adults with chronic hepatitis B who underwent liver biopsy in routine clinical practice.
- Trial name
- CHB-PATH (NCT07843446)
- Where
- Turkey (Türkiye)
- Volunteers
- 1,201 people
- Sponsor
- Istanbul Medeniyet University
Hepatitis C
Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination in Treatment-Naïve Hepatitis C Virus Participants (MK-5172-067)
This is a randomized, parallel-group, placebo-controlled, multi-site, multinational, double-blind followed by open label period, Phase 3 trial of 100 mg of grazoprevir (MK-5172) in combination with 50 mg of elbasvir (MK-8742)…
- Trial name
- NCT02251990
- Testing
- Grazoprevir/Elbasvir
- Volunteers
- 489 people
- Sponsor
- Merck Sharp & Dohme LLC
Psoriatic Arthritis
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).
- Trial name
- NCT06671483
- Testing
- Zasocitinib, Active Comparator
- Where
- 188 sites in United States, Belgium and 18 more
- Volunteers
- 1,088 people
- Sponsor
- Takeda
HIV-1 Infection
Safety and Efficacy of Doravirine, Tenofovir, Lamivudine (MK-1439A) in Participants Infected With Treatment-Naïve Human Immunodeficiency Virus (HIV) -1 With Transmitted Resistance (MK-1439A-030)
The primary objectives of this study are to evaluate the antiretroviral activity and the safety/tolerability of open-label doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF; MK-1439A; DELSTRIGO™) consisting of a…
- Trial name
- DRIVE BEYOND (NCT02629822)
- Testing
- Doravirine/lamivudine/tenofovir disoproxil fumarate
- Volunteers
- 10 people
- Sponsor
- Merck Sharp & Dohme LLC