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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR PURINETHOL

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Clinical Trials for Purinethol

Trial ID Title Status Sponsor Phase Summary
NCT00287170 Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's Disease Completed Teva GTC Phase 1/Phase 2 The study is being undertaken to evaluate whether delayed-release medications, designed to begin to open in the lower intestinal tract, the main site of Crohn's Disease, are more effective than standard systemically delivered drugs to promote remission or response in CD patients. It is hypothesized that the delayed-release medications will go right to the injured tissue and heal the disease more quickly. The delayed-release test drugs are 6-mercaptopurine (at a dose of 40 mg daily) or calcitriol (at a dose of 5 mcg three times a week) versus Purinethol (6-MP at a dose of 1-2 mg/kg body weight daily). Calcitriol is a synthetically manufactured replica of a natural substance in the body that is derived from Vitamin D. There is much medical evidence that shows that lack of Vitamin D can be a possible risk factor in developing autoimmune disorders, including Crohn's Disease. Moreover, calcitriol has been shown in animal models to improve the symptoms of Crohn's Disease.
NCT00548431 NOPHO ALL-2008 Pilot Study on Consolidation Therapy for Children and Adolescents With Acute Lymphoblastic Leukemia Completed Rigshospitalet, Denmark Phase 2 The present pharmacokinetic (PK)-pharmacodynamic (PD) study will explore the toxicity and antileukemic response during the initial 3 months of individualised therapy of children and young adults with acute lymphoblastic leukemia (ALL). The investigators will on an individual toxicity-titrated basis attempt to increase the dose intensity of the 6-mercaptopurine used in the two-months post-remission treatment phase of lower risk childhood ALL. This will be performed together with continuous PEG-ASP (every 2nd week) and interspersed HD-MTX (5 g/m^2) every 3rd week. Thus, the trial will also test the feasibility of this particular drug combination.
NCT00602134 Bioequivalence Study of 6-Mercaptopurine Under Fasting Conditions Completed Roxane Laboratories N/A The objective of this study was to assess the bioequivalence of a potential generic 6-mercaptopurine 50 mg tablet formulation compared with GlaxoSmithKline Purinethol® (mercaptopurine) 50-mg scored tablets following a single 50 mg oral dose administered in the fasted state.
NCT00648336 Fasting Study of Mercaptopurine 50 mg and Purinethol® Tablets 50 mg Completed Mylan Pharmaceuticals Phase 1 The objective of this study was to investigate the bioequivalence of Mylan's mercaptopurine 50 mg tablets to Gate's Purinethol® 50 mg tablets following a single, oral 50 mg (1 x 50 mg) dose administered under fasting conditions.
NCT00774982 Pilot Comparative Bioavailability Study of 6Mercaptopurine (Delayed Release vs. Purinethol) in Crohns Disease Patients Completed Teva GTC Phase 1 The study is being conducted to evaluate the pharmacokinetic parameters (Cmax, Tmax and AUC) of the new delayed release, lowered dose, 40 mg 6MP test formulation as compared to standard 6MP (100 mg Purinethol) in 12 patients with Crohn's Disease. The study is being undertaken to prove that the new test formulation is indeed delayed-release and targeted to the ileum, and that the levels of 6MP in the blood following local absorption are lower than that seen following standard Purinethol dosing. This should result in lower, safer mercaptopurine dosing, allowing for uninterrupted treatment with fewer side effects.
NCT01094613 Multicenter Clinical Efficacy and Safety Study of Delayed Release 6MP in Crohn's Disease Terminated Teva GTC Phase 1/Phase 2 The study is designed to evaluate the clinical efficacy and safety of daily treatment for 12 weeks of oral administration of a delayed release, locally delivered 6MP (mercaptopurine) drug (80 mg), as compared to standard Purinethol (at a dose of 1-1.5 mg/kg/body weight), in alleviating the clinical, immunological and mucosal signs and symptoms of moderately active Crohn's Disease
NCT01371630 Study of the Combination of Inotuzumab Ozogamycin (CMC-544) With Low-intensity Chemotherapy in Patients With Acute Lymphoblastic Leukemia (ALL) Recruiting Pfizer Phase 1/Phase 2 The goal of the Phase I part of this clinical research study is to test 2 dose levels of the drug inotuzumab ozogamycin to find the highest tolerable dose that can be given in combination with chemotherapy. The goal of Phase II is to learn if inotuzumab ozogamycin given in combination with chemotherapy can help to control ALL. The safety of the study drugs will also be studied. Inotuzumab ozogamycin is designed to attach to a protein that is often found in leukemia cells. This may cause the cancer cells to die. Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to die. Hyper-CVAD includes a combination of cyclophosphamide, vincristine, dexamethasone, methotrexate, Ara-C (cytarabine), and Neulasta (pegfilgrastim). The maintenance therapy used in this study is called POMP, which includes a combination of mercaptopurine, methotrexate, vincristine, and prednisone. These chemotherapy drugs are designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Purinethol

Condition Name

Condition Name for Purinethol
Intervention Trials
Acute Lymphoblastic Leukemia 5
Crohn's Disease 3
Leukemia 3
Untreated Adult Acute Lymphoblastic Leukemia 1
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Condition MeSH

Condition MeSH for Purinethol
Intervention Trials
Precursor Cell Lymphoblastic Leukemia-Lymphoma 9
Leukemia, Lymphoid 8
Leukemia 7
Crohn Disease 5
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Clinical Trial Locations for Purinethol

Trials by Country

Trials by Country for Purinethol
Location Trials
United States 6
Israel 4
Denmark 2
South Africa 1
Netherlands 1
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Trials by US State

Trials by US State for Purinethol
Location Trials
Texas 3
Pennsylvania 1
North Dakota 1
Arizona 1
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Clinical Trial Progress for Purinethol

Clinical Trial Phase

Clinical Trial Phase for Purinethol
Clinical Trial Phase Trials
Phase 4 1
Phase 3 3
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Purinethol
Clinical Trial Phase Trials
Completed 6
Recruiting 5
Not yet recruiting 2
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Clinical Trial Sponsors for Purinethol

Sponsor Name

Sponsor Name for Purinethol
Sponsor Trials
Teva GTC 4
M.D. Anderson Cancer Center 3
Mylan Pharmaceuticals 1
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Sponsor Type

Sponsor Type for Purinethol
Sponsor Trials
Other 11
Industry 11
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Queensland Health
Chinese Patent Office
Cipla
Healthtrust
Baxter
Harvard Business School
Dow

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