Clinical trials: Treatment naïve
Chronic Hepatitis C Virus Infection
Phase I/IIa Dose Ranging CHRONVAC-C® Study in Chronic HCV Patients
The purpose of this study is to evaluate if the DNA vaccine CHRONVAC-C® intended for future treatment of Hepatitis C infections is safe and tolerated when administered to HCV infected individuals with a low viral load.
- Trial name
- NCT00563173
- Testing
- CHRONVAC-C®
- Where
- 2 sites in Sweden
- Volunteers
- 12 people
- Sponsor
- Tripep AB
Severe Aplastic Anemia (SAA)
Combination of Eltrombopag With Immunosuppressive Therapy in East-Asian Patients With Severe Aplastic Anemia
This study was designed to evaluate the efficacy and safety of eltrombopag when added to r-ATG and CsA in treatment naive East-Asian adult and pediatric patients with severe aplastic anemia (SAA).
- Trial name
- REACTS (NCT04328727)
- Testing
- eltrombopag, rabbit anti-thymocyte globulin (r-ATG), cyclosporine A (CsA)
- Where
- 12 sites in China, Japan and 2 more
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
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.
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.
Primary Immunodeficiency
A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency
The purpose of the study is to determine whether biweekly (every 2 weeks) administration of Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) produces a steady-state area under the…
- Trial name
- NCT04566692
- Testing
- IGSC 20%
- Where
- 12 sites in United States
- Volunteers
- 33 people
- Sponsor
- Grifols Therapeutics LLC
Hepatitis C
Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.
- Trial name
- NCT00780416
- Testing
- MP-424, Ribavirin, Peginterferon Alfa-2b
- Where
- Japan
- Volunteers
- 189 people
- Sponsor
- Tanabe Pharma Corporation
Diabetes Mellitus, Type 2
Lantus Versus Levemir Treat-To-Target
Primary objective: To demonstrate the non-inferiority of insulin glargine in comparison to insulin detemir in term of percentage of patients who reach the target of HbA1c < 7% at the end of the treatment period and do not…
- Trial name
- L2T3 (NCT00405418)
- Testing
- Insulin glargine, Insulin Detemir
- Where
- 20 sites in Australia, Brazil and 18 more
- Volunteers
- 973 people
- Sponsor
- Sanofi
Hepatitis C, Chronic
This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C
The objective of this trial is to investigate tolerability, safety, pharmacokinetics and antiviral activity of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks in Japanese treatment-naive patients with…
- Trial name
- NCT01528735
- Testing
- BI 207127 NA, peginterferon, Ribavirin
- Where
- 5 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Boehringer Ingelheim
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.
HIV Infections
Pharmacokinetics, Pharmacodynamics, And Safety Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus
To investigate the relationship between the pharmacokinetics and pharmacodynamics of UK-427,857 and its antiviral effects in patients with human immunodeficiency virus (HIV).
- Trial name
- NCT00643643
- Testing
- Maraviroc (UK-427,857)
- Where
- 6 sites in Germany, Netherlands and 1 more
- Volunteers
- 41 people
- Sponsor
- ViiV Healthcare
HIV
Open-Label Study Comparing Efficacy and Safety of ATV/RTV+3TC With ATV/RTV+TDF/FTC in HIV-Infected, Treatment Naïve Subjects, Followed by Treatment With ATV/RTV+3TC
The primary objective of this study in antiretroviral (ARV)-naïve Human immunodeficiency virus 1 (HIV-1) ribonucleic acid infected subjects is to compare the response rate at Week 48 of a daily regimen of Atazanavir (ATV)/…
- Trial name
- NCT01620944
- Testing
- Atazanavir, Ritonavir, Lamivudine
- Volunteers
- 3 people
- Sponsor
- Bristol-Myers Squibb
Diabetes, Diabetes Mellitus, Type 2
A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients
This trial is conducted globally. The aim of this trial is to compare stepwise insulin intensification of biphasic insulin aspart (BIAsp) 30 and basal-bolus therapy with insulin glargine and insulin aspart in insulin naïve type 2…
- Trial name
- NCT02453685
- Testing
- biphasic insulin aspart 30, insulin glargine, insulin aspart
- Where
- 41 sites in Australia, Bulgaria and 7 more
- Volunteers
- 335 people
- Sponsor
- Novo Nordisk A/S
Metastatic Non Small Cell Lung Cancer
Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer…
- Trial name
- TROPION-Lung08 (NCT05215340)
- Testing
- Datopotamab Deruxtecan, Pembrolizumab
- Where
- 234 sites in United States, Argentina and 26 more
- Volunteers
- 740 people
- Sponsor
- Daiichi Sankyo
Diabetes Mellitus, Type 2
Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure
Primary objective: To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) < 7% at the end of the comparative period (24 weeks) in Type 2…
- Trial name
- EAGLE (NCT01117350)
- Testing
- Insulin glargine, Liraglutide, Metformin
- Where
- 136 sites in United States, Austria and 15 more
- Volunteers
- 978 people
- Sponsor
- Sanofi
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
Diabetes Mellitus Type 2
A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea.
This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared to insulin glargine in patients with insulin-naive type 2 diabetes mellitus inadequately controlled with metformin and sulphonylurea…
- Trial name
- NCT00755287
- Testing
- insulin glargine, metformin, taspoglutide
- Where
- 210 sites in United States, Australia and 25 more
- Volunteers
- 1,072 people
- Sponsor
- Hoffmann-La Roche
Hypertension
Effectiveness of a Valsartan Based Versus an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy
The population for this current study will include stage 1 and stage 2 hypertensive patients who are newly diagnosed or didn't have treatment during the last 3 months and patients who are currently treated but uncontrolled on…
- Trial name
- NCT00304226
- Testing
- valsartan, amlodipine
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 1,288 people, healthy volunteers welcome
- Sponsor
- Novartis
Growth Hormone Disorder, Growth Hormone Deficiency in Children
Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone
This study is conducted in Europe. The purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Genetic Disorder, Turner Syndrome
- Trial name
- NCT01327924
- Testing
- Norditropin NordiFlex®
- Where
- France
- Volunteers
- 77 people
- Sponsor
- Novo Nordisk A/S
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
Infection, Human Immunodeficiency Virus I, HIV Infection
GW873140 In Combination With Kaletra In HIV Infected Subjects
This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Kaletra in HIV infected, untreated subjects.
- Trial name
- NCT00102778
- Testing
- GW873140, Kaletra (lopinavir/ritonavir)
- Where
- 70 sites in United States, Canada and 8 more
- Volunteers
- 175 people
- Sponsor
- ViiV Healthcare