Clinical trials: Treatment naïve
Chronic Hepatitis C Infection
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil
The purpose of this study is to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with 3…
- Trial name
- NCT02442271
- Testing
- ombitasvir/paritaprevir/ritonavir and dasabuvir, ribavirin
- Volunteers
- 222 people
- Sponsor
- AbbVie
Diabetes, Diabetes Mellitus, Type 2
Observational Study on Safety of Self-titration of Once Daily Levemir®
This study is conducted in Europe. The main objective of the study is to assess the safety of self-titration in type 2 diabetic patients on antidiabetic tablets who are receiving insulin for the first time.
- Trial name
- SOLVE™ (NCT00740519)
- Testing
- insulin detemir
- Where
- United Kingdom
- Volunteers
- 882 people
- Sponsor
- Novo Nordisk A/S
Pancreatic Neoplasms
A Randomized Phase 2 Study of ARQ 197 Versus Gemcitabine in Treatment-Naïve Patients With Unresectable Locally Advanced or Metastatic Pancreatic Adenocarcinoma
This is a multi-center, open-label randomized phase 2 study designed to assess the progression free survival (PFS) of patients with untreatment and unresectable pancreatic cancer following treatment with either ARQ 197 or…
- Trial name
- NCT00558207
- Testing
- ARQ 197, gemcitabine
- Where
- 6 sites in Poland
- Volunteers
- 43 people
- Sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
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
Type 2 Diabetes Mellitus
Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic Patients
Primary: Effect on HbA1c over 6 months in drug-naive patients with type 2 diabetes Secondary: Effect on glucose, insulin, C-peptide, insulin resistance, body weight, HDL-cholesterol, triglycerides, blood pressure - Safety…
- Trial name
- SERENADE (NCT00257257)
- Testing
- Rimonabant (SR141716)
- Where
- 7 sites in United States, Argentina and 5 more
- Volunteers
- 281 people
- Sponsor
- Sanofi
Myelodysplastic Syndromes
A Study to Evaluate Luspatercept Treatment Patterns and Outcomes in Erythropoiesis-Stimulating Agents-Naïve Patients With Lower-Risk Myelodysplastic Syndromes in the United States
The purpose of this study is to understand real-world effectiveness of luspatercept treatment among erythropoiesis-stimulating agents -naïve patients with lower-risk- myelodysplastic syndromes in the United States
- Trial name
- NCT06851065
- Testing
- Luspatercept, Erythropoiesis-stimulating agents
- Where
- United States
- Volunteers
- 418 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis C
An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants
The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of…
- Trial name
- NCT00528528
- Testing
- Telaprevir, Peg-IFN-alfa-2a, Peg-IFN-alfa-2b
- Where
- 24 sites in Austria, Belgium and 4 more
- Volunteers
- 166 people
- Sponsor
- Tibotec BVBA
HIV
TMC114-C211: Trial of an Investigational Protease Inhibitor TMC114 With Ritonavir ("TMC114/r") in HIV-1 Infected Patients Who Have Never Been Treated With Antiretroviral Medications.
The purpose of this study is to compare the efficacy, safety and tolerability of TMC114/r versus Kaletra (a combination pill of lopinavir and ritonavir, ("lpv/rtv") in HIV-1 infected patients who have never been treated with…
- Trial name
- NCT00258557
- Testing
- LPV/RTV, TMC-114/RTV
- Where
- 89 sites in United States, Argentina and 23 more
- Volunteers
- 692 people
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Type 2 Diabetes Mellitus
A Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey
Primary Objective: To assess the mean change in HbA1c (glycated haemoglobin). Secondary Objectives: To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of: Targeted HbA1c; Targeted fasting self…
- Trial name
- EASE (NCT02954692)
- Testing
- INSULIN GLARGINE (U300), metformin, sulfonylurea
- Where
- Turkey (Türkiye)
- Volunteers
- 112 people
- Sponsor
- Sanofi
Melanoma
A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma
The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.
- Trial name
- NCT06054555
- Testing
- ABP 206, Nivolumab
- Where
- 180 sites in United States, Argentina and 29 more
- Volunteers
- 633 people
- Sponsor
- Amgen
Multiple Myeloma
Study of Tecemotide (L-BLP25) in Subjects With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy
Tecemotide (L-BLP25) is believed to induce a Mucinous glycoprotein 1 (MUC1)-specific T-cell response after vaccination. The primary purpose of this study is to ascertain whether vaccination with tecemotide (L-BLP25) induces a…
- Trial name
- NCT01094548
- Testing
- Tecemotide (L-BLP25), Single low dose cyclophosphamide, Multiple low dose cyclophosphamide
- Where
- Germany
- Volunteers
- 34 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
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.
HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients
Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer
To compare the efficacy and safety of PERT-IJS (Proposed biosimilar Pertuzumab) plus trastuzumab and chemotherapy (carboplatin and docetaxel) versus EU-Perjeta plus trastuzumab and chemotherapy (carboplatin and docetaxel) in…
- Trial name
- NCT06038539
- Testing
- PERT-IJS plus trastuzumab, carboplatin and docetaxel, Perjeta plus trastuzumab, carboplatin and docetaxel
- Where
- India
- Volunteers
- 55 people
- Sponsor
- Biocon Biologics UK Ltd
Tumor, Colorectal Cancer
NKTR-102 in Combination With Cetuximab in Patients With Refractory Solid Tumors (Phase 2a) and Metastatic or Locally Advanced Colorectal Cancer (Phase 2b)
Study 07-PIR-02 is a Phase 2 study designed to evaluate the safety and efficacy of NKTR-102 (PEG-irinotecan) for the treatment of patients with colorectal cancer (CRC).
- Trial name
- NCT00598975
- Testing
- NKTR-102 100 mg/m2, NKTR-102 125 mg/m2, Cetuximab
- Where
- 4 sites in United States
- Volunteers
- 18 people
- Sponsor
- Nektar Therapeutics
HIV-1, HIV Infection
DOR/ISL in Pediatric Participants With HIV-1, <18 Years of Age and ≥ 35 kg
This is a phase 2 study of the pharmacokinetics, safety, and efficacy of oral doravirine/islatravir (100 mg/0.25 mg) [MK-8591A] in pediatric participants with human immunodeficiency virus type 1 (HIV-1) infection who are…
- Trial name
- NCT07862569
- Testing
- DOR/ISL
- Volunteers
- 45 people
- Sponsor
- Merck Sharp & Dohme LLC
Higher Risk Myelodysplastic Syndromes
Bexmarilimab + Azacitidine Versus Placebo + Azacitidine in Participants With Treatment-naïve Higher-risk Myelodysplastic Syndromes
This Phase IIb study (BEXERA) will evaluate the safety and efficacy of bexmarilimab (FP-1305), an antibody targeting Clever-1, given in combination with azacitidine compared with azacitidine plus placebo in adults with…
- Trial name
- BEXERA (NCT07672769)
- Testing
- bexmarilimab (1mg/kg), azacitidine, bexmarilimab (3mg/kg)
- Where
- 35 sites in United States, Czechia and 5 more
- Volunteers
- 90 people
- Sponsor
- Faron Pharmaceuticals Ltd
Type 2 Diabetes
A Trial Comparing Efficacy and Safety of GZR101 and IDegAsp in Insulin Naïve or Insulin Treated Subjects with T2DM
This trial is conducted in China. The aim of the trial is to compare the efficacy and safety of GZR101 and insulin degludec/insulin aspart in insulin naïve or insulin treated subjects with type 2 diabetes.
- Trial name
- NCT06199505
- Testing
- GZR101, insulin degledec/insulin aspart
- Where
- China
- Volunteers
- 153 people
- Sponsor
- Gan and Lee Pharmaceuticals, USA
Chronic Hepatitis C
A Study of Debio 025 (Alisporivir) Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients
The purpose of this study is to compare several Debio 025 (alisporivir)/peg-IFNα2a/ribavirin triple therapies with the current standard of care (SOC) in treatment naïve chronic hepatitis C genotype 1 patients.
- Trial name
- NCT00854802
- Testing
- Debio 025, Peg-IFNα2a, Ribavirin
- Where
- 40 sites in Belgium, France and 5 more
- Volunteers
- 290 people
- Sponsor
- Debiopharm International SA
Chronic Hepatitis C Infection
A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).
- Trial name
- NCT01225380
- Testing
- GS-9190, GS-9256, Pegasys®
- Where
- 114 sites in United States, Austria and 9 more
- Volunteers
- 324 people
- Sponsor
- Gilead Sciences
Arthritis, Psoriatic
Remicade Study in Psoriatic Arthritis Patients Of Methotrexate-Naïve Disease (RESPOND) (Study P04422)
This study is undertaken to compare the efficacy and onset of action of infliximab plus methotrexate (IFX + MTX) versus methotrexate alone (MTX) in methotrexate naïve active psoriatic arthritis patients.
- Trial name
- NCT00367237
- Testing
- Infliximab + methotrexate (IFX + MTX), Methotrexate (MTX)
- Volunteers
- 115 people
- Sponsor
- Merck Sharp & Dohme LLC