NCT01437020 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Addy M, Nandy A
Ten years of kala-azar in west Bengal, Part I. Did post-kala-azar dermal leishmaniasis initiate the outbreak in 24-Parganas? Bull World Health Organ. 1992;70(3):341-6.
Bern C, Hightower AW, Chowdhury R, Ali M, Amann J, Wagatsuma Y, Haque R, Kurkjian K, Vaz LE, Begum M, Akter T, Cetre-Sossah CB, Ahluwalia IB, Dotson E, Secor WE, Breiman RF, Maguire JH
Risk factors for kala-azar in Bangladesh. Emerg Infect Dis. 2005 May;11(5):655-62.
Desjeux P
Leishmaniasis. Public health aspects and control. Clin Dermatol. 1996 Sep-Oct;14(5):417-23. Review.

A Phase I/II Clinical Trial To Assess the Safety and Biologic Activity of the Anti-IL-10 Monoclonal Antibody, SCH708980, in Combination With AmBisome(Registered Trademark), Versus That of Placebo in Combination With Ambisome(Registered Trademark), in Subjects With Visceral Leishmaniasis (VL)

Details for clinical trial NCT01437020

Clinical trial NCT01437020 - References