Clinical trials: Treatment naïve
Chronic Hepatitis C Infection, Genotype 1
A Phase 1b/2a Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C
This is an open-label, randomized, safety, tolerability, dose-finding, PK/PD, and preliminary efficacy study of subcutaneous Hanferon™ in combination with ribavirin(RBV) in treatment-naïve subjects with genotype 1 hepatitis C.
- Trial name
- NCT01194037
- Testing
- recombinant variant of interferon-alpha 2b, Peginterferon alfa-2a, Ribavirin
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- HanAll BioPharma Co., Ltd.
Fabry Disease
Agalsidase Beta Long-Term Treatment Outcome for Fabry Disease Patients With IVS4 Mutation in Taiwan
This is a national, multicenter, observational, cohort study designed to assess clinical outcomes upon agalsidase beta treatment, to characterize the clinical manifestations, and to collect the natural history on male and female…
- Trial name
- NCT06052800
- Where
- 5 sites in Taiwan
- Volunteers
- 78 people
- Sponsor
- Sanofi
Hepatitis C, Chronic
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection.
This 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups.
- Trial name
- NCT00517439
- Testing
- Copegus, Pegasys, RO4588161
- Where
- 63 sites in United States, Australia and 7 more
- Volunteers
- 516 people
- Sponsor
- Hoffmann-La Roche
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, HIV Infections
Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV
The purpose of this study is to determine whether the combination of telaprevir, peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus (HCV) infection in subjects who are infected with both HCV…
- Trial name
- NCT00983853
- Testing
- peginterferon alfa-2a, ribavirin (fixed dose), ribavirin (weight-based dose)
- Where
- 16 sites in United States, France and 2 more
- Volunteers
- 62 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
NSCLC
A Survival Study for Women With Advanced Lung Cancer Who Have Not Previously Received Chemotherapy.
This is a randomized, open-label, multinational, phase III study in women with histologically- or cytologically-confirmed advanced NSCLC who are chemotherapy naïve and have PS 2.
- Trial name
- PIONEER (NCT00269828)
- Testing
- paclitaxel, paclitaxel poliglumex
- Where
- 143 sites in United States, Argentina and 9 more
- Volunteers
- 600 people
- Sponsor
- CTI BioPharma
Mucopolysaccharidosis III, Type B (MPS IIIB), Sanfilippo B
A Open Label Study in Previously Studied, SBC-103 Treatment Naïve MPS IIIB Subjects to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics/Efficacy of SBC-103 Administered Intravenously
This study evaluated the safety and tolerability of intravenous (IV) administration of SBC-103 in previously studied, SBC-103 treatment naïve patients with mucopolysaccharidosis III, type B (MPS IIIB, Sanfilippo B) who…
- Trial name
- CL01-T (NCT02618512)
- Testing
- SBC-103
- Where
- United Kingdom
- Volunteers
- 3 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
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.
Hepatitis B
Efficacy and Safety of Telbivudine in Treatment naïve Patients With Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB)
To evaluate the combination of telbivudine 600 mg orally (PO) once daily and peginterferon alpha-2a 180 ug subcutaneous (sq) injection weekly for antiviral efficacy in comparison to peginterferon alpha-2a monotherapy.
- Trial name
- NCT00412750
- Testing
- Telbivudine (LdT), peginterferon alpha-2a
- Where
- United States
- Volunteers
- 159 people
- Sponsor
- Novartis
Systemic Treatment-naïve Pancreatic Cancer
HRS-4642 Combined With Antitumor Agents for the Treatment of Perioperative Pancreatic Cancer
The study is being conducted To evaluate the efficacy of HRS-4642 in combination with gemcitabine plus nab-paclitaxel (AG) (± SHR-1316) versus standard therapy in participants, high-risk resectable/borderline resectable…
- Trial name
- NCT07900789
- Testing
- HRS -4642 + SHR-1316+ Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection, HRS -4642 + Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection, Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection
- Where
- 2 sites in China
- Volunteers
- 825 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Chronic Hepatitis, Hepatitis B
Efficacy and Safety of Clevudine Compared With Adefovir in Patients With 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, 72 weeks, and 96 weeks.
- Trial name
- QUASH2 (NCT00496158)
- Testing
- Clevudine, Adefovir
- Where
- 119 sites in United States, Argentina and 9 more
- Sponsor
- Pharmasset
Relapsed/Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20).
- Conditions
- Relapsed/Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Richter's Syndrome, Treatment-naïve High Risk Chronic Lymphocytic Leukemia
- Trial name
- EPCORE™ CLL-1 (NCT04623541)
- Testing
- Epcoritamab, rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone, Venetoclax
- Where
- 81 sites in United States, Australia and 10 more
- Volunteers
- 194 people
- Sponsor
- Genmab
Hepatitis C, Chronic
Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)
The purpose of this study is to assess the safety and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C virus (HCV) infection.
- Trial name
- NCT01371604
- Testing
- IDX184, Peginterferon alfa-2a (Peg-IFN), Ribavirin (RBV)
- Volunteers
- 68 people
- Sponsor
- Merck Sharp & Dohme 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
Hepatitis C
A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response
This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their…
- Trial name
- NCT00758043
- Testing
- telaprevir, ribavirin, peginterferon alfa-2a
- Where
- 82 sites in United States, Belgium and 2 more
- Volunteers
- 540 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Treatment-naïve Severe Aplastic Anemia
A Study of Romiplostim N01 Plus IST vs. Placebo Plus IST for Treatment-Naive Severe Aplastic Anemia
This is a randomized, double-blind, multicenter trial designed to evaluate treatment with romiplostim N01+ IST compared with placebo + IST in the participants with treatment-naïve severe aplastic anemia.
- Trial name
- NCT07345000
- Testing
- Romiplostim N01, Cyclosporine A (CsA), pALG/ rATG
- Volunteers
- 210 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Myelodysplastic Syndromes
A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve
The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at…
- Trial name
- COMMANDS (NCT03682536)
- Testing
- Luspatercept, Epoetin alfa
- Where
- 226 sites in United States, Australia and 24 more
- Volunteers
- 363 people
- Sponsor
- Celgene
Diabetic Macular Edema
A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated
This study will evaluate the efficacy and safety of OZURDEX in patients with Diabetic Macular Edema when used in a real world setting in Spain and Portugal.
- Trial name
- EYEberia (NCT03953807)
- Testing
- Dexamethasone Intravitreal Implant
- Where
- 26 sites in Portugal, Spain
- Volunteers
- 82 people
- Sponsor
- Allergan
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
Hepatitis C
Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1
This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC), each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American participants who have never received…
- Trial name
- NCT01446250
- Testing
- Alisporivir, Boceprevir, Peginterferon alfa-2a
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Debiopharm International SA