Clinical trials: Therapy Failure
Hepatitis C
Efficacy and Safety of Combination Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Sofosbuvir + Pegylated Interferon + Ribavirin in Hepatitis C Virus Genotype 1, 4 or 6 Infection (MK-5172-077)
This is a study comparing grazoprevir (MK-5172) plus elbasvir (MK-8742) treatment with sofosbuvir (SOF) plus Pegylated Interferon plus Ribavirin (RBV) [PR] treatment in treatment-naïve and prior PR treatment failure participants…
- Trial name
- NCT02358044
- Testing
- Sofosbuvir, PegIntron, Ribavirin
- Volunteers
- 257 people
- Sponsor
- Merck Sharp & Dohme LLC
Lead Insulation Failure
Therapy Coil Electrogram Collection Study
This is a prospective, non-randomized, multicenter, post market release study which will collect electrograms (EGMs) from patients at risk of a suspected insulation failure to the high voltage portion of the defibrillator lead…
- Trial name
- TEC (NCT02314598)
- Testing
- No treatment
- Where
- 2 sites in Slovakia
- Volunteers
- 46 people
- Sponsor
- Medtronic BRC
Chronic Renal Failure, Chronic Kidney Disease
A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC) Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb) levels and study drug dose requirements in patients…
- Trial name
- AiME - 13 (NCT01473420)
- Testing
- Epoetin Hospira, Epogen Amgen
- Where
- 73 sites in United States
- Volunteers
- 320 people
- Sponsor
- Pfizer
Heart Failure
Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads
The QP ExCELs study is designed to confirm safety and efficacy of the BIOTRONIK Sentus OTW QP left ventricular leads to satisfy FDA requirements for regulatory approval of the leads in the US.
- Trial name
- QP ExCELs (NCT02290028)
- Testing
- Sentus QP left ventricular lead
- Where
- 119 sites in United States, Australia and 9 more
- Volunteers
- 2,226 people
- Sponsor
- Biotronik SE & Co. KG
Respiratory Insufficiency, Sleep Disordered Breathing
Adjustment of Mask Pressure, for Bilevel Positive Airways Pressure Therapy, by Automated Algorithm
The aim of the study is to test the hypothesis that an automated algorithm for desired mask pressure improves breathing pattern and sleep quality in patients with hypercapnic ventilatory failure.
- Trial name
- NCT01403584
- Testing
- AutoVPAP with addition of AutoEPAP, AutoVPAP with EPAP manually selected
- Where
- Germany
- Volunteers
- 21 people
- Sponsor
- ResMed
Chronic Heart Failure
Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure
The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- ADVANCE (NCT00751972)
- Testing
- HeartWare® VAS
- Where
- 35 sites in United States
- Volunteers
- 140 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Chronic Kidney Disease, End Stage Renal Disease
TARGTEPO Treatment for Anemia in Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD)
The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment.
- Trial name
- NCT02117427
- Testing
- MDGN201 TARGTEPO
- Where
- 5 sites in Israel
- Volunteers
- 11 people
- Sponsor
- Aevi Genomic Medicine, LLC, a Cerecor company
Heart Failure
The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients
This is a phase IV, prospective, randomized, double-blind, double-dummy, parallel-group study. The study assessed the effects of 6 weeks of stable sacubitril/valsartan therapy, as compared with valsartan therapy, on the…
- Trial name
- TurkuPET (NCT03300427)
- Testing
- sacubitril/valsatran, valsartan
- Where
- Finland
- Volunteers
- 55 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure, Congestive, Myocardial Infarction
IMPROVE HF: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting
The purpose of this study is to characterize current management of patients with either heart failure or prior myocardial infarction and left ventricular dysfunction and to assess the effect of education, specific clinical…
- Conditions
- Heart Failure, Congestive, Myocardial Infarction, Ventricular Dysfunction, Left
- Trial name
- IMPROVE-HF (NCT00303979)
- Where
- 144 sites in United States
- Volunteers
- 34,810 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Moderate to Severe Rheumatoid Arthritis
Evaluating Etanercept Use in Patients With Moderate to Severe Rheumatoid Arthritis Who Have Lost Response to Adalimumab
To evaluate the efficacy of etanercept in adults with moderate-to-severe rheumatoid arthritis (RA) who did not respond to or lost a satisfactory response to adalimumab when used as their first biologic agent.
- Trial name
- ROCkIES (NCT01927757)
- Testing
- Etanercept, Methotrexate
- Where
- 45 sites in United States, Canada and 1 more
- Volunteers
- 90 people
- Sponsor
- Amgen
Growth Hormone Deficiency, Endocrine System Diseases
A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency
A 38-week dosing trial of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus placebo-control.
- Conditions
- Growth Hormone Deficiency, Endocrine System Diseases, Hormone Deficiency
- Trial name
- foresiGHt (NCT04615273)
- Testing
- Lonapegsomatropin, Somatropin
- Where
- 113 sites in United States, Armenia and 22 more
- Volunteers
- 264 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Chronic Kidney Failure, Secondary Hyperparathyroidism
Paricalcitol Oral Therapy in Predialysis CKD Patients. The Greek Experience
The purpose of this study is to obtain data on the use of Zemplar (paricalcitol) capsules in real-life clinical practice in predialysis patients with chronic kidney disease (CKD) and secondary hyperparathyroidism.
- Trial name
- PROTECT (NCT01083186)
- Where
- 24 sites in Greece
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- AbbVie (prior sponsor, Abbott)
Myelodysplastic Syndromes
Trial of Volasertib With or Without Azacitidine in Patients With Myelodysplastic Syndromes
The objectives of this trial are to evaluate the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics and preliminary efficacy of volasertib in two dosing schedules of intravenous volasertib as monotherapy or in…
- Trial name
- NCT02721875
- Testing
- Volasertib, Azacitidine
- Where
- Japan
- Volunteers
- 1 people
- Sponsor
- Boehringer Ingelheim
Hepatitis B, Chronic
Tenofovir Disoproxil Fumarate (TDF) 300mg 3 Years RD Therapy Chinese Chronic Hepatitis B (CHN) CHB Multiple Nucleos(t)Ide Analogues (NAs) Failure Points Pts PH4 PMS Study
This is a phase IV, single-arm, open-label, multi-centre study to assess the efficacy of TDF in Chronic hepatitis B (CHB) subjects following failure of multiple Nucleos(t)ide analogues (NAs).
- Trial name
- NCT02195518
- Testing
- Tenofovir disoproxil fumarate
- Where
- 12 sites in China
- Volunteers
- 213 people
- Sponsor
- GlaxoSmithKline
Anemia, Kidney Diseases
DELFT (Dynepo Evaluation of Long-Term Follow-Up Treatment)
This is a post-authorisation safety study to assess the incidence and severity of all pre-defined cardiovascular events in patients treated with DYNEPO, as well as to detect \& describe less common adverse drug reactions, and to…
- Conditions
- Anemia, Kidney Diseases, Renal Failure, Chronic, Kidney Failure, Chronic
- Trial name
- DELFT (NCT00664066)
- Testing
- DYNEPO (epoetin delta)
- Where
- 2 sites in Germany
- Volunteers
- 3 people
- Sponsor
- Shire
Nonsmall Cell Lung Cancer, NSCLC
Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Standard of Care Therapies for Treatment of Stage 4 Non-small Cell Lung Cancer (NSCLC) Following Platinum Failure (LUNAR)
The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of TTFields, using the NovoTTF-200T device, concurrent with standard therapies for stage 4 NSCLC patients, following…
- Trial name
- NCT02973789
- Testing
- NovoTTF-200T, Immune checkpoint inhibitors or docetaxel
- Where
- 124 sites in United States, Austria and 16 more
- Volunteers
- 291 people
- Sponsor
- NovoCure GmbH
Kidney Failure, Chronic
Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Zemplar® (Paricalcitol Injection) in the Treatment of Patients Suffering From End-stage Renal Disease and Severe Over-reactivity of the Parathyroid Glands
This observational study will evaluate the clinical benefit of Zemplar (paricalcitol injection) in daily routine practice in end-stage renal disease patients with severe over-reactivity of parathyroid glands.
- Trial name
- NCT01273597
- Where
- 11 sites in Hungary
- Volunteers
- 60 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Kidney Failure
Quantitative Mass Transfer of SFP-iron From Dialysate to Blood in CKD-HD Patients
The purpose of this study is to determine the quantity of iron derived from SFP that is transferred from the dialysate to patients during a single dialysis session.
- Trial name
- NCT01894906
- Testing
- Soluble Ferric Pyrophosphate
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Rockwell Medical Technologies, Inc.
Schizophrenia
15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated
The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 15 months, in patients diagnosed with schizophrenia who have been…
- Trial name
- NCT01157351
- Testing
- paliperidone, risperidone, haloperidole
- Where
- 56 sites in United States, Puerto Rico
- Volunteers
- 450 people
- Sponsor
- Janssen Scientific Affairs, LLC
Cardiac Edema
A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive Heart Failure)
To investigate the plasma drug level, efficacy, and safety of 7-day repeated oral administration of OPC-41061 at 15 mg/day (treatment period 1) and subsequent 7-day repeated administration of OPC-41061 at 15 mg/day or 30 mg/day…
- Trial name
- NCT00544869
- Testing
- OPC-41061 （Tolvaptan)
- Where
- 6 sites in Japan
- Volunteers
- 52 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.