Clinical trials: Patient Safety
Hepatitis C, Chronic
Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059)
The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks) versus standard 48 week treatment in previously untreated adult participants with chronic hepatitis C (CHC) genotype 4 infection who…
- Trial name
- START 4 (NCT01606800)
- Testing
- PEG-IFN alfa-2b, ribavirin
- Volunteers
- 45 people
- Sponsor
- Merck Sharp & Dohme LLC
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
Study to Assess an Enteric Microgranule Formulation of Adrulipase in Patients With Cystic Fibrosis
Some cystic fibrosis patients are unable to digest food and absorb nutrition appropriately as they have a condition known as exocrine pancreatic insufficiency (EPI).
- Trial name
- SPAN (NCT05719311)
- Testing
- adrulipase
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Entero Therapeutics
Amyloidosis, Familial, Transthyretin Amyloidosis
Patisiran in Patients With Hereditary Transthyretin-mediated Amyloidosis (hATTR Amyloidosis) Disease Progression Post-Liver Transplant
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of patisiran in participants with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) with disease progression after liver…
- Trial name
- NCT03862807
- Testing
- Patisiran
- Where
- 9 sites in France, Germany and 5 more
- Volunteers
- 24 people
- Sponsor
- Alnylam Pharmaceuticals
Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy
Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy
Study to evaluate the Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(radiculo)neuropathy
- Trial name
- CIDP (NCT02638207)
- Testing
- NewGam
- Where
- 26 sites in Bulgaria, Canada and 7 more
- Volunteers
- 142 people
- Sponsor
- Octapharma
Alpha 1-Antitrypsin Deficiency
Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT)
The purpose of AROAAT2001 (SEQUOIA) is to evaluate the safety, efficacy and tolerability of multiple doses of the investigational product, Fazirsiran Injection, administered subcutaneously to participants with alpha-1 antitrypsin…
- Trial name
- SEQUOIA (NCT03945292)
- Testing
- Fazisiran Injection
- Where
- 21 sites in United States, Germany and 4 more
- Volunteers
- 40 people
- Sponsor
- Arrowhead Pharmaceuticals
Gaucher Disease, Type 1
A Study of Eliglustat Tartrate (Genz-112638) in Patients With Gaucher Disease Who Have Reached Therapeutic Goals With Enzyme Replacement Therapy (ENCORE)
This Phase 3 study was designed to confirm the efficacy and safety of eliglustat tartrate (Genz-112638) in participants with Gaucher disease type 1 who had reached therapeutic goals with enzyme replacement therapy (ERT).
- Trial name
- ENCORE (NCT00943111)
- Testing
- Eliglustat tartrate, Imiglucerase
- Where
- 34 sites in United States, Argentina and 10 more
- Volunteers
- 160 people
- Sponsor
- Genzyme, a Sanofi Company
AMN, AMN Gene Mutation
A Study to Evaluate Administration of SBT101 Gene Therapy in Adult Patients With Adrenomyeloneuropathy (AMN)
This is a Phase 1/2 randomized, blinded, dose-escalation study to evaluate the safety and efficacy of intrathecal (IT) administration of SBT101, a recombinant adeno-associated virus serotype 9 (AAV9) containing a functional copy…
- Conditions
- AMN, AMN Gene Mutation, X-ALD
- Trial name
- PROPEL (NCT05394064)
- Testing
- SBT101 Treatment
- Where
- 2 sites in United States, Netherlands
- Volunteers
- 9 people
- Sponsor
- SwanBio Therapeutics, Inc.
Chronic Thromboembolic Pulmonary Hypertension
A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment
Selexipag is available in many countries for the treatment of pulmonary arterial hypertension (PAH). Due to the similarities between PAH and chronic thromboembolic pulmonary hypertension (CTEPH) and the observed efficacy of other…
- Trial name
- SELECT (NCT03689244)
- Testing
- Selexipag
- Where
- 162 sites in United States, Argentina and 29 more
- Volunteers
- 128 people
- Sponsor
- Actelion
Uveitis
A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis
The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear…
- Trial name
- NCT04088409
- Testing
- Baricitinib, Adalimumab
- Where
- 20 sites in France, Germany and 3 more
- Volunteers
- 30 people
- Sponsor
- Eli Lilly and Company
Paroxysmal Nocturnal Hemoglobinuria
Pozelimab and Cemdisiran Combination Therapy in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Who Switch From Eculizumab Therapy
The primary objective of the study is to evaluate the safety and tolerability of pozelimab and cemdisiran combination therapy in participants with PNH who switch from eculizumab therapy The secondary objectives of the study are…
- Trial name
- NCT04888507
- Testing
- Pozelimab, Cemdisiran
- Where
- United Kingdom
- Volunteers
- 6 people
- Sponsor
- Regeneron Pharmaceuticals
Acute Non-cardioembolic Ischemic Stroke
Study to Gather Information About Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following a Recent Non Cardioembolic Ischemic Stroke Which Occurs When a Blood Clot Has Formed Somewhere in the Human Body (But Not in the Heart) Travelled to the Brain.
The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of antiplatelet therapy in patients following a recent non…
- Trial name
- PACIFIC-STROKE (NCT04304508)
- Testing
- BAY2433334
- Where
- 197 sites in United States, Australia and 21 more
- Volunteers
- 1,808 people
- Sponsor
- Bayer
Diabetes Mellitus, Type 2
Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Japanese Patients With Type 2 Diabetes Mellitus
Two independent study parts (i.e. Part A and Part B) are included in this trial. Part A will evaluate empagliflozin 10 mg + linagliptin and Part B will evaluate empagliflozin 25 mg + linagliptin.
- Trial name
- NCT02489968
- Testing
- empagliflozin 10 mg + linagliptin 5 mg, empagliflozin 10 mg, empagliflozin 25 mg + linagliptin 5 mg
- Where
- 83 sites in Japan
- Volunteers
- 880 people
- Sponsor
- Boehringer Ingelheim
Alzheimer Disease
A Preliminary Study of 18F-AV-45 in Alzheimer's Disease and Healthy Elderly Volunteers
A preliminary study to test how florbetapir F 18 (18F-AV-45) acts in the brains and bodies of healthy elderly people and patients with Alzheimer's Disease (AD) by using a positron emission tomography (PET) scanner.
- Trial name
- NCT01565291
- Testing
- florbetapir F 18
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Avid Radiopharmaceuticals
Alcoholic Hepatitis
A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis
This is a research trial testing DUR-928 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928 in patients with moderate and severe…
- Trial name
- AH (NCT03432260)
- Testing
- DUR-928 30 mg, DUR-928 90 mg, DUR-928 150 mg
- Where
- 7 sites in United States
- Volunteers
- 19 people
- Sponsor
- Durect
Rheumatoid Arthritis
A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.
This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with active rheumatoid arthritis who currently…
- Trial name
- NCT00773461
- Testing
- tocilizumab [RoActemra/Actemra]
- Where
- 9 sites in China
- Volunteers
- 209 people
- Sponsor
- Hoffmann-La Roche
Advanced Colorectal Carcinoma
A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions
A Phase 1 dose escalation study to evaluate APR003 in patients with advanced colorectal cancer (CRC) with malignant liver lesions
- Trial name
- NCT04645797
- Testing
- APR003
- Where
- 4 sites in United States
- Volunteers
- 11 people
- Sponsor
- Apros Therapeutics, Inc
Hypertension
Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg After 1 Week of Treatment Withdrawal
This study was specifically designed to provide additional information on the mechanism of action of direct renin inhibition postulating the higher-level RAS cascade inhibition.
- Trial name
- ASSERTIVE (NCT00865020)
- Testing
- Aliskiren, Telmisartan
- Where
- 16 sites in Brazil, Canada and 14 more
- Volunteers
- 822 people
- Sponsor
- Novartis
Inoperable Locally Advanced or Metastatic Biliary Tract Cancer
Selumetinib (AZD6244, ARRY-142886) J-BTC Phase 1 Study
The objective of this study is to investigate the safety and tolerability of oral dose of selumetinib in combination with chemotherapies (cisplatin and gemcitabine) in Japanese patients with advanced biliary tract cancer (BTC).
- Trial name
- NCT01949870
- Testing
- Cisplatin, Gemcitabine, Selumetinib
- Where
- 2 sites in Japan
- Volunteers
- 6 people
- Sponsor
- AstraZeneca
Epilepsy
Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Participants With Partial Onset Seizures With or Without Secondary Generalization
This is a multi-center, open-label, single-arm, phase 4 study to evaluate the efficacy of perampanel added to monotherapy for partial onset seizures with or without secondarily generalized seizures (total seizures).
- Trial name
- NCT02726074
- Testing
- Perampanel
- Where
- 6 sites in South Korea
- Volunteers
- 106 people
- Sponsor
- Eisai Korea Inc.
Hemophilia B
A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B.
- Trial name
- NCT01496274
- Testing
- rIX-FP
- Where
- 30 sites in United States, Austria and 8 more
- Volunteers
- 63 people
- Sponsor
- CSL Behring
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