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Generated: February 22, 2019

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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.
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
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Condition MeSH

Condition MeSH for Purinethol
Intervention Trials
Precursor Cell Lymphoblastic Leukemia-Lymphoma 10
Leukemia, Lymphoid 9
Leukemia 8
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Clinical Trial Locations for Purinethol

Trials by Country

Trials by Country for Purinethol
Location Trials
United States 7
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 4
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 6
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Clinical Trial Status

Clinical Trial Status for Purinethol
Clinical Trial Phase Trials
Completed 6
Recruiting 6
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 4
Pfizer 2
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Sponsor Type

Sponsor Type for Purinethol
Sponsor Trials
Other 12
Industry 12
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Fuji
UBS
Federal Trade Commission
Baxter
QuintilesIMS
Colorcon
Medtronic
Chubb

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