Clinical trials: Treatment naïve
Anemia, Renal Insufficiency, Chronic
15141 Fixed Dose Correction / naïve and Pre Dialysis (Europe and Asia Pacific)
Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood.
- Trial name
- DIALOGUE 1 (NCT02021370)
- Testing
- BAY85-3934
- Where
- 56 sites in Australia, Bulgaria and 12 more
- Volunteers
- 121 people
- Sponsor
- Bayer
Crohn Disease
A Study of Real-World Outcomes of People With Crohn's Disease (CD)
The main aim of this study is to compare long-term remission in participants receiving vedolizumab (VDZ) and those receiving ustekinumab (UST). In this study, the study doctors will review each participant's past medical records.
- Trial name
- EVOLVE (NCT05056441)
- Where
- 31 sites in Australia, Belgium and 1 more
- Volunteers
- 623 people
- Sponsor
- Takeda
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL
This study is to determine the response to acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Trial name
- NCT02337829
- Testing
- Acalabrutinib (Arm A), Acalabrutinib (Arm B)
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Acerta Pharma BV
Hepatitis B, Chronic Hepatitis B Atypical
Safety, Tolerability, Pharmacokinetics and Antiviral Activity of IONIS-HBVRx in Treatment-Naïve Patients With Chronic HBV Infection
To examine the safety and tolerability of IONIS-HBVRx administration to treatment-naive patients with chronic hepatitis B virus infection
- Trial name
- NCT02981602
- Testing
- IONIS-HBVRx
- Where
- 7 sites in Hong Kong, South Korea
- Volunteers
- 31 people
- Sponsor
- GlaxoSmithKline
Hepatitis C Virus (HCV)
A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection
The objectives of this study are to assess the pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir adult formulation in adolescents ages 12 to 17 years and a pediatric formulation of glecaprevir and pibrentasvir in…
- Trial name
- DORA (NCT03067129)
- Testing
- Glecaprevir/Pibrentasvir Adult Formulation, Glecaprevir + Pibrentasvir Pediatric Formulation
- Where
- 38 sites in United States, Belgium and 7 more
- Volunteers
- 129 people
- Sponsor
- AbbVie
Type II Diabetes Mellitus
Safety and Efficacy Study of JTT-130 in Obese Type 2 Diabetic Patients
The purpose of this study is to evaluate the effect of JTT-130 on diabetes as well as the safety and tolerability of JTT-130 in obese Type 2 diabetic patients.
- Trial name
- NCT00929539
- Testing
- JTT-130
- Where
- 62 sites in United States, Czechia and 3 more
- Volunteers
- 496 people
- Sponsor
- Shionogi Inc.
Non-Hodgkin Lymphoma
Comparing Interleukin-2 (IL-2) Combined With Rituximab (Rituxan) to Rituximab Alone in Subjects With Non-Hodgkin's Lymphoma (NHL)
The purpose of this study is to determine whether interleukin-2 given 3 times weekly for 8 weeks in combination with rituximab is effective and safe when compared to rituximab given alone in the treatment of follicular NHL…
- Trial name
- NCT00100737
- Testing
- interleukin-2, rituximab
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Chiron Corporation
Aplastic Anemia
A Study of the Safety and Effectiveness of Eltrombopag in Combination With Immunosuppressive Therapy (IST) in Korean Pediatric Patients With Treatment Naïve Severe Aplastic Anemia
The aim of this study was to investigate the safety, tolerability, and effectiveness of eltrombopag in combination with immunosuppressive therapy (IST) in real world practice in pediatric patients with severe aplastic anemia…
- Trial name
- NCT07415083
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals
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
Chronic Hepatitis C, Hepatitis C Virus (HCV) Infection
Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in combination with pegylated interferon/ribavirin…
- Trial name
- NCT01314261
- Testing
- ABT-267, Pegylated interferon (pegIFN), Ribavirin (RBV)
- Where
- 11 sites in United States, Puerto Rico
- Volunteers
- 37 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Hepatitis C
A Phase 3 Study to Evaluate Combination Therapy With Daclatasvir and Sofosbuvir in the Treatment of HIV and Hepatitis C Virus Coinfection.
A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the treatment of hepatitis C virus and HIV coinfection.
- Trial name
- NCT02032888
- Testing
- Daclatasvir, Sofosbuvir
- Where
- 37 sites in United States
- Volunteers
- 238 people
- Sponsor
- Bristol-Myers Squibb
HIV Infections
Induction-Maintenance With Atazanavir in HIV Naïve Patients (The INDUMA Study)
The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load < 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an…
- Trial name
- INDUMA (NCT00207142)
- Testing
- Atazanavir + 2 NRTIs, Atazanavir + Ritonavir + 2 NRTIs
- Where
- 27 sites in Estonia, France and 8 more
- Volunteers
- 252 people
- Sponsor
- Bristol-Myers Squibb
Pain
Clinical Usefulness and Quality of Life of OROS Hydromorphone in Patients Who Have Not Been Treated With a Strong Opioid
The primary purpose of this study is to evaluate the usefulness of hydromorphone to treat cancer pain in patients who have not been treated with a strong opioid.
- Trial name
- NCT01532895
- Testing
- Hydromorphone HCI OROS
- Where
- 11 sites in South Korea
- Volunteers
- 400 people
- Sponsor
- Janssen Korea, Ltd., Korea
Hepatitis C
Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-9669 in Subjects With Chronic Hepatitis C Virus Infection
This is a research study to evaluate the safety, tolerability and anti-viral activity of GS-9669 in patients with Hepatitis C infection.
- Trial name
- NCT01431898
- Testing
- GS-9669 tablets
- Where
- 11 sites in United States, Puerto Rico
- Volunteers
- 82 people
- Sponsor
- Gilead Sciences
Lymphocytic Leukemia, Chronic
CHAIROS Study A Study of MabThera/Rituxan (Rituximab) Maintenance Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Naive to Chemotherapy
This study will evaluate the efficacy and safety of intense combination treatment including MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients with B-cell CLL who are naive to chemotherapy.
- Trial name
- NCT02013817
- Testing
- rituximab [MabThera/Rituxan], fludarabine, cyclophosphamide
- Where
- 8 sites in Austria
- Volunteers
- 43 people
- Sponsor
- Hoffmann-La Roche
Parkinson's Disease
Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment
The purposes of the study are to determine: i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine) ii.
- Trial name
- NCT00489255
- Testing
- Tigan®
- Where
- 27 sites in United States
- Volunteers
- 117 people
- Sponsor
- Ipsen
Hepatitis C, Chronic Pain
Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve…
- Trial name
- NCT01215643
- Testing
- Alisporivir, Peginterferon alfa-2a, Ribavirin
- Where
- 73 sites in United States, Australia and 12 more
- Volunteers
- 340 people
- Sponsor
- Debiopharm International SA
HIV
Study on Long Term Outcomes of Atazanavir in Antiretroviral-naïve Human Immunodeficiency Virus (HIV) Patients in Real Life Setting
The purpose of this study is to describe long term (> 96 weeks) efficacy and safety of Atazanavir-based regimens in real life setting.
- Trial name
- REMAIN (NCT01236235)
- Where
- 53 sites in Germany, Portugal and 1 more
- Volunteers
- 525 people
- Sponsor
- Bristol-Myers Squibb
Diabetes, Diabetes Mellitus, Type 2
Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin
This trial is conducted in Asia, Europe, Oceania and South America. The aim of this clinical trial is to generate data demonstrating how to intensify diabetes treatment using BIAsp 30 (biphasic insulin aspart 30) by adding or…
- Trial name
- SIT2MIX (NCT01519674)
- Testing
- biphasic insulin aspart 30, sitagliptin, metformin
- Where
- 69 sites in Argentina, Australia and 8 more
- Volunteers
- 582 people
- Sponsor
- Novo Nordisk A/S
HIV -1 Infection, HIV Infections
Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection
The purpose of this study is: 1. To assess the antiviral activity of PRO 140 2. To assess the safety and tolerability of PRO 140 3. To generate additional PK, PD and safety data of PRO 140
- Trial name
- NCT00642707
- Testing
- PRO 140 (humanized monoclonal antibody to CCR5)
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- CytoDyn, Inc.