Research and Clinical Trials

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Research and Clinical Trials

Dr. Sabine Hazan is a pioneer in the research and clinical trials field.  Over the last 17 years, Dr. Hazan has conducted over 50 studies on topics such as Hepatitis C, Peptic Ulcer Disease, and Coronary Heart Disease.  Here is the list of her most recent work in last 8 years.

Recent Research and Clinical Trials

1. Pozen; PPI / Aspirin study phase 4.

2. Boehringer‐ Ingelheim; Hepatitis C phase 4.

3. Salix; IBS drug phase 3.

4. Takeda; IBD drug phase 4.

5. Merk; Peptic ulcer disease phase 3

6. Glaxo; Peptic ulcer disease phase 4

7. TAP; PPI phase 4.

8. GlaxoSmith Kline; Hepatitis C phase 2.

9. Daiichi Sankyo; Coronary heart disease phase 3.

10. Novartis; Hepatitis C phase 3.

11. GSK; Herpes Labialis phase 3.

12. Centocor : psoriasis phase 4

13. Salix, Gastroparesis phase 3

14. BI. A.fib.

15. Roche Aleprevent.

16. Amgen 138, 356, 348.

17. GSK, Asthma

18. Merck, C.diff

19. Sanofi Pasteur, C.diff vaccine

20. Merck, Peds DM 21. Theravance, Gastroparesis phase 2.

22. Tranzyme, Gastroparesis phase 2.

23. Premier , Gastroparesis phase 2.

24. GSK, COPD phase 3.

25. Merck, Hepatitis c.

26. Furiex 3001, IBSD phase 3.

27. Furiex 3002, IBSD phase 3.

28. Merck, Psoriasis phase 3.

29. Astellas, Spec study.

30. Paragon, Ulcer phase 3.

31. Roche, Alecardio.

32. Roche, Aleprevent

33. Promethius, UC.

34. Targacept, Gastroparesis

35. Genentech ,Crohn’s

36. Genntech ,Ulcerative colitis

37. Acerta 003, Pancreatic Cancer

38. Alcresta, Chronic Pancreatitis

39. Summit, C.diff

40. Chiltern, Constipation

41. Abblynx, RA

42. Pfizer, RA

43. Rhythm, Gastroparesis

44. Salix, Liver Failure

45. Pfizer, Hyperlipidemia 1045,1022,1038

46. Forrest LIND62, LIND63, Constipation

47. Ironwood, Gastroparesis

48. Perrigo, NY14‐008, HSV1

49. PSI, UC

50. Hutchinson Pharma, UC

51. Legacy, crohn’s

52. Synterac, Chronic Pancreatitis

53. Acerta 004, Pancreatic Cancer

DETAILS OF TRIALS BELOW: 

Ironwood Gastroparesis ICP-112-202
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 2a Study of Oral IW-9179 Administered Once and Twice Daily for 4 Weeks to Patients With Diabetic Gastroparesis.

C.DiffVaccine H-030-014
Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection

Redhill RHB-104-01
A Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects With Moderately to Severely Active Crohn’s Disease

Ablynx Rheumatoid Arthritis C201
A Phase IIb Multicenter, Randomized, Double-blind, Placebo-Controlled Dose-Range Finding Study of ALX-0061 Administered Subcutaneously in Combination With Methotrexate, in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Ablynx Rheumatoid Arthritis C202
A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects With Moderate to Severe Rheumatoid Arthritis Who Are Intolerant to Methotrexate or for Whom Continued Methotrexate Treatment is Inappropriate

Pfizer B1481045
A 52 Week Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

Rhythm Gastro-DM
A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis

Pfizer Rheumatoid A392133
Phase 3b/4 Randomized Safety Endpoint Study Of 2 Doses Of Tofacitinib In Comparison To A Tumor Necrosis Factor (Tnf) Inhibitor In Subjects With Rheumatoid Arthritis

UC- Genentech Laurel GA29102
PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAÏVE TO TNF INHIBITORS

UC- Cottonwood GA289511
AN OPEN LABEL EXTENSION AND SAFETY MONITORING STUDY OF MODERATE TO SEVERE ULCERATIVE COLITIS PATIENTS PREVIOUSLY ENROLLED IN ETROLIZUMAB PHASE III STUDIES

Chrons Bergamont GA29144
AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

Juniper Chrons GA29145
AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

Chronic Margarine ALD-403-CLIN-005
A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Phase 2 Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALD403 Administered Intravenously in Patients With Chronic Migraine

Pfizer B1481022
Phase 3 Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (Pf-04950615) In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects

Pfizer B1481038
Phase 3 Multi Center, Double Blind, Randomized, Placebo Controlled, Parallel Group Evaluation Of The Efficacy, Safety, And Tolerability Of Bococizumab (pf 0495061), In Reducing The Occurrence Of Major Cardiovascular Events In High Risk Subjects

Kowa- Ankle Sprain K-103-IP-3.01US
This is a randomized, double blind, placebo controlled, parallel group study to assess the efficacy and safety of K-103-IP compared with placebo patch for treatment of mild to moderate acute pain associated with ankle strain or sprain.

Ankle Sprain Diclo-13-01
Randomized, Double-Blind, Multiple-Center, Placebo-Controlled Study Comparing the Safety and Efficacy of Generic Diclofenac Epolamine to Flector® Patch in the Treatment of Acute Pain Due to Minor Ankle Sprain

Merck- Cdiff MK 3415A
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of a Single Infusion of MK-6072 (Human Monoclonal Antibody to C. Difficile Toxin B), and MK-3415A (Human Monoclonal Antibodies to C. Difficile Toxin A and B) in Patients Receiving Antibiotic Therapy for C. Difficile Infection (MODIFY II)

Quintiles- Psoriasis GP17-301
A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Adalimumab (GP2017) and Humira® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

Merck- Psoriasis MK3222-011
A 52-Week, Phase 3, Randomized, Active Comparator and Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-011)

Perrigo- Herpes NY-14-008
A Multi-Center, Double- Blin, Randomized Vehicle- Controlled, Parallel-Group Study To Compare Perrigo UK FINCO’s Acyclovir Cream, 5% With ZOVIRAX Acyclovir) Cream 5% And Both Active Treatments To A Vehicle Control In Treatment Of Recurrent Herpes Simplex Labialls

Amgen- 20120138
A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145

Amgen-20120348
A Multi-center, Randomized Study in Subject With Primary Hypercholesterolemia or Mixed Dyslipidemia to Assess Subjects’ Ability to Administer a Full Dose of AMG 145 in Home-use, Using Either a prefilled syringe or a Prefilled Autoinjector/Pen

Amgen- 20120356
A Multi-center, Randomized Study in Subject With Primary Hypercholesterolemia or Mixed Dyslipidemia to Assess Subjects’ Ability to Administer a Full Dose of AMG 145 in Home-use, Using Either a 3.5 ml Personal Injector or a Prefilled Autoinjector/Pen

Astellas 3006-CL-3004
A Phase 3b, Open-Label, Parallel Group, Randomized, Multicenter Study to Assess Regadenoson Administration Following an Inadequate Exercise Stress Test as Compared to Regadenoson Alone for Myocardial Perfusion Imaging (MPI) Using Single Photon Emission Computed Tomography (SPECT)

Clinipace
A Randomized, Blinded, Endoscopic Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects

Furiex 27018966IBS3001
A Randomized, Double-blind, Placebo-controled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome

Furiex 27018966IBS3002
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome

Asthma SAS 115359
SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects With Asthma

Merck- Hep C MK3034-040-03
A Phase 3, Safety and Efficacy Study of Boceprevir/Peginterferon Alfa-2a/Ribavirin in Chronic HCV Genotype 1 IL28B CC Subjects

Pozen- PA 32540-301
A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers

Roche- Aleprevent BC28027
A PHASE 3B STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE CARDIOVASCULAR RISK IN PATIENTS WITH STABLE CARDIOVASCULAR DISEASE AND GLUCOSE ABNORMALITIES

Theravance- Gastroparsis 0093
A Multicenter, Double-Blind, Randomized, Placebo- Controlled, Phase 2 Study to Evaluate
Velusetrag Effects on Gastric Emptying in Subjects With Diabetic or Idiopathic Gastroparesis

Salix RNLC2131
A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications in Subjects With Early Decompensated Liver Cirrhosis

Chiltren SP 304203-04
A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

HMPL-004-04
A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects With Mild to Moderate Ulcerative Colitis With Clinical Remission or Response From Induction Therapy. (NATRUL-4)

HMPL-004-03
A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis

BAY 59-7939/16416
Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary Embolism

Summit- C.Diff
A Phase II, Randomized, Double-Blind, Active-Controlled Clinical Study To Investigate the Efficacy and Safetly of SMT19969 (200 mg BID) for 10 Days Compared with Vancomycin (125 mg QID) for 10 days for the Treatment of Clostridium diffcile- Associated Diarrhoea (CDAD)

Merck- Peds DM MK-0431AXR 289
A Phase III Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safetly and Efficacy of MK-0431AXR (a Fixed-Dose Combination Tabletof Sitagliptin and Extended-Release Metformin) in Pediatric Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Metformin Monotherapy

TOPSTONE CHF- AR 06.009
Randomized, Open-Label, Daily Dose, 2-sequence, 2-way Crossover Pharmacodynamic and Pharmacokinetic Study of BiDil XR Capsules and Commercial BiDil Tablets in Self-identified Black Patients, Who Are Slow Acetylators, With Heart Failure

Seres Therapeutics
A Randomized, Double-Blinded, Placebo-Controlled, Parallel Group Study of SER-109 to Prevent Recurrent Clostridium difficle Infection (SERES-004)

PSI- UC 4083-002
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy and Long-term Extension Therapy) of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis

Pancreatic Cancer ACE- ST-003/ ACE 004
A Phase 2 Proof-of-Concept Study of ACP-169 Alone and in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Pancreatic Cancer

Cancer- ACE-ST-006
A Phase 2 Proof-of-Concept Study of the Combination of ACP-196 and Pembrolizumab in Subjects with Advanced Head And Neck Squamous Cell Carcinoma
A Phase 2, Randomized, Proof-of-Concept Study of Nab-Paclitaxel/Gemcitabine Alone and in Combination with ACP-196 in Subjects with Previously Untreated Metastatic Pancreatic Cancer

Chronic Pancreatitis
NI03-001 – A Phase 1, Single Dose PK and Safety Study with NI-03 Followed by a Phase 2, Randomized, Double-Blind, Parallel-Group Dose-Ranging Study to Evaluate the Safety and Efficacy of NI-03 When Compared to Placebo in Subjects with Chronic Pancreatitis

Targacept- Gastroparesis Phase 1 TC 6499-12CLP-005
Gastroparesis, also referred to as delayed gastric emptying, is a debilitating, chronic disorder that slows or stops the passage of food from the stomach to the small intestine. The purpose of this study is to test whether TC-6499 is safe and effective at reducing gastric emptying time in diabetic subjects with gastroparesis.

TRANZYME- Gastroparesis Phase II TPZ 102-CL-G004
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Efficacy and Safety of TZP-102 Given Orally Three Times a Day for the Treatment of Symptoms Associated With Diabetic Gastroparesis

Forrest- LIN-MD-62
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 6 to 17 Years, Who Fulfil Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)

Forrest- LIN-MD-63
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 7 to 17 Years, With Irritable Bowel Syndrome With Constipation (IBS-C) (ie, Fulfil Rome III Criteria foe Child/Adolescent IBS and Fulfil Modified Rome III Criteria for Child/Adolescent Functional Constipation)

COPD- HZC113782
A Clinical Outcomes Study to Compare the effect of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg with placebo on Survival in Subjects with moderate Chronic Obstructive Pulmonary Disease (COPD) and a history of or at increased risk for cardiovascular disease

Alcresta ALCT-460-0000135
A Randomized, Double-Blind Crossover Study to Evaluate Safety, Tolerability, and Rate and Extent of Absorption of Long-Chain Polyunsaturated Fatty Acids After Exposure to ALCT-460 in Pancreatic Insufficient Subjects

Boehringer Ingelheim 1160.129
GLORIA-AF: Global Registry on Long-Term Oral Anti-thrombotic Treatment In Patients With Atrial Fibrillation (Phase II/III)