Clinical trials: Treatment naïve
Hepatitis C, Chronic
PEG-IFN Alfa-2b Plus Ribavirin for Treatment of Mexican naïve Patients With Chronic Hepatitis C Infected With Genotype 1 (Study P04511)(COMPLETED)
This study aims to evaluate the efficacy and safety of peginterferon alfa-2b plus weight-based ribavirin as initial treatment in chronic hepatitis C virus (HCV) genotype 1 patients.
- Trial name
- NCT00724620
- Testing
- Peginterferon alfa-2b (SCH 054031), Ribavirin (SCH 018908)
- Volunteers
- 103 people
- Sponsor
- Schering-Plough
Mature B-cell Malignancies
Study of Zanubrutinib in Japanese Participants With B-Cell Malignancies
This is a Phase 1/2 study of zanubrutinib in Japanese participants with mature B-cell malignancies. This study intends to assess the use of zanubrutinib as an investigational agent to develop new treatment options for Japanese…
- Trial name
- NCT04172246
- Testing
- Zanubrutinib
- Where
- 15 sites in Japan
- Volunteers
- 55 people
- Sponsor
- BeiGene
Primary Immunodeficiency Disease (PIDD)
Monitoring of 5% Treatment Naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) Patients Using the CareExchange® System: A Pilot Study Using 5% Gammaplex® IVIg in the Home Setting
The purpose of this study is to demonstrate the utility of measuring outcomes in 5% treatment naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) patients using infusion nurse and patient measured…
- Trial name
- NCT02176239
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- BriovaRx Infusion Services
Crohn Disease, Colitis, Ulcerative
A Study to Observe the Safety and Efficacy of Vedolizumab in Biologically Naive Participants With Ulcerative Colitis (UC) or Crohn´s Disease (CD)
The purpose of this non-interventional study (NIS) study is to assess further knowledge on the routine use of Entyvio in inflammatory bowel disease therapy, particularly the use in participants with CD and UC naive to biologics.
- Conditions
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
- Trial name
- CHRONOS (NCT02986724)
- Where
- Austria
- Volunteers
- 60 people
- Sponsor
- Takeda
Hepatitis C
A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3
The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver…
- Trial name
- NCT02551861
- Testing
- Daclatasvir, Sofosbuvir, Ribavirin
- Where
- 12 sites in Canada, France
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis C Infection, Hepatitis C
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as dasabuvir) and ribavirin (RBV) in…
- Conditions
- Chronic Hepatitis C Infection, Hepatitis C, Hepatitis C Virus
- Trial name
- NCT01306617
- Testing
- ABT-450, ABT-333, ribavirin
- Where
- 11 sites in United States
- Volunteers
- 50 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Hypertension
A Real-world Study of the Safety of Hypertension Medication Therapy in Japanese Patients With Naïve Hypertension
This was a non-interventional, secondary use of data, retrospective, cohort study. The data extracted in this study was used as secondary use of collected patient information in the database, Japan Medical Data Survey (JAMDAS)…
- Trial name
- NCT06683768
- Where
- United States
- Volunteers
- 40,563 people
- Sponsor
- Novartis Pharmaceuticals
Progressive Metastatic Prostate Cancer
An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants
Purpose of the study was to assess the effect of enzalutamide on time to Prostate Specific Antigen (PSA) progression as compared to placebo in chemotherapy naïve participants with progressive metastatic prostate cancer who have…
- Trial name
- NCT02294461
- Testing
- Enzalutamide
- Where
- 47 sites in China, Hong Kong and 2 more
- Volunteers
- 395 people
- Sponsor
- Astellas Pharma Inc
Advanced Prostate Cancer
Therapy Pathways in the Treatment of Hormone Naïve Prostate Cancer Patients With and Without Comorbidities Treated With Degarelix or Luteinizing-Hormone-Releasing-Hormone (LHRH) Agonists.
The purpose of this study is to detect factors influencing decision making for treatment pathways of hormone-naïve prostate cancer patients with and without comorbidities receiving medicinal androgen deprivation therapy…
- Trial name
- ProComD (NCT02234089)
- Testing
- Degarelix, LHRH agonist (Leuprorelinacetat, Goserelinacetat, Buserelinacetat, Triptorelinacetat)
- Where
- Germany
- Volunteers
- 461 people
- Sponsor
- Ferring Pharmaceuticals
Metastatic Urothelial Carcinoma, Urothelial Carcinoma
N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer
This phase Ib trial will investigate the effect of N-803 in combination with pembrolizumab and enfortumab vedotin in treating participants with urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced)…
- Conditions
- Metastatic Urothelial Carcinoma, Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Urothelial Cancer
- Trial name
- NCT07217496
- Testing
- Nogapendekin Alfa Inbakicept (NAI), enfortumab vedotin (EV), Pembrolizumab
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- ImmunityBio, Inc.
Hepatitis C
Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)
To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in…
- Trial name
- NCT00984620
- Testing
- BI 201335, Pegylated Interferon-alpha (IFN), Ribavirin (RBV)
- Where
- 28 sites in United States, Austria and 4 more
- Volunteers
- 160 people
- Sponsor
- Boehringer Ingelheim
Relapse Remitting Multiple Sclerosis
Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
This study evaluates the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes.
- Trial name
- AGNOS (NCT05084638)
- Testing
- Ofatumumab
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Chronic HCV Infection
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants…
- Trial name
- NCT02021656
- Testing
- LDV/SOF
- Where
- 45 sites in China, South Korea and 1 more
- Volunteers
- 384 people
- Sponsor
- Gilead Sciences
Adenocarcinoma of the Prostate
First in Man Clinical Study to Evaluate Safety and Tolerability of an Oncolytic Adenovirus in Prostate Cancer Patients.
This open label, dose escalating study is a phase I/IIa first in man study designed to evaluate the safety and tolerability of intratumoral administration of a novel oncolytic adenovirus (ORCA-010) in treating diagnosed treatment…
- Trial name
- NCT04097002
- Testing
- ORCA-010
- Where
- 5 sites in Canada
- Volunteers
- 24 people
- Sponsor
- Orca Therapeutics B.V.
Diabetes Mellitus Type 2
A Study of Aleglitazar in Monotherapy in Patients With Type 2 Diabetes Mellitus Who Are Drug-Naïve to Anti-Hyperglycemic Therapy
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety and tolerability of aleglitazar monotherapy in patients with Type 2 diabetes mellitus who are drug-naïve to…
- Trial name
- NCT01871428
- Testing
- aleglitazar
- Where
- 7 sites in China, Hong Kong and 1 more
- Volunteers
- 13 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C
Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients
Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100 mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B status (CC or CT/TT).
- Trial name
- NCT01054729
- Testing
- Sofosbuvir, PEG, RBV
- Where
- 7 sites in United States, Puerto Rico
- Volunteers
- 64 people
- Sponsor
- Gilead Sciences
Systemic Lupus Erythematosus
A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus
The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as add-on therapy to an anti-malarial, with or without…
- Trial name
- SUNFLOWER (NCT07430306)
- Testing
- Anifrolumab
- Where
- 107 sites in United States, Canada and 7 more
- Volunteers
- 245 people
- Sponsor
- AstraZeneca
Primary Immunodeficiency Diseases (PID)
A Study of TAK-664 in People With Primary Immunodeficiency Diseases Who Have Not Yet Been Treated With Immunoglobulins
Primary immunodeficiency disease (or PIDD) is a group of conditions in which the immune system does not work properly. Some people with PIDD do not make enough antibodies.
- Trial name
- NCT07794735
- Testing
- TAK-664
- Volunteers
- 9 people
- Sponsor
- Takeda
Type 1 Diabetes
Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy
Primary Outcomes: Average decrease in A1c from baseline to end of Study Phase (52 weeks) for subjects in the "722 Group" is greater than that for subjects in the "Control (MDI) Group".
- Trial name
- STAR3 (NCT00417989)
- Testing
- MiniMed Paradigm REAL-Time System
- Where
- 30 sites in United States, Canada
- Volunteers
- 485 people
- Sponsor
- Medtronic MiniMed, Inc.
Chronic Hepatitis C Virus
VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C
The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.
- Trial name
- NCT01581138
- Testing
- VX-222, telaprevir, ribavirin
- Where
- 18 sites in United States
- Volunteers
- 64 people
- Sponsor
- Vertex Pharmaceuticals Incorporated