Clinical Trial: An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Open-label, Dose-finding, 2-parts, Efficacy Phase II Study With Three Formulations (Racemate Praziquantel Commercial Oral Tablets, New Oral Disintegrating Tablets of Racemate Praziquantel and L-praziq

Brief Summary: The Phase II study consisting of two parts, part 1 is open label, randomized, controlled and exploratory dose finding in children aged between 2 and 6 years infected with S. mansoni. Part 2a investigates efficacy and safety in children 3 months to 2 years in an age-de-escalating design and part 2b is optional and investigates the efficacy of L-PZQ in S. hematobium.

Detailed Summary:
Sponsor: Merck KGaA

Current Primary Outcome: Number of Subjects with Clinical Cure [ Time Frame: 14 to 21 days post treatment ]

Clinical cure is defined as no parasite eggs in the stools 14-21 days after treatment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Egg Reduction Rate [ Time Frame: Baseline, 14-21 days post treatment ]
    Egg reduction rate will be calculated as mean egg count per gram of stool before and after 14-21 days after treatment.
  • Number of subjects with Cure [ Time Frame: 14- 21 days post treatment ]
    Cure defined as no evidence of parasite as measured with Point-of-Care Circulating Cathodic Antigen (POC-CCA) test.


Original Secondary Outcome: Same as current

Information By: Merck KGaA

Dates:
Date Received: June 16, 2016
Date Started: June 2016
Date Completion: July 2017
Last Updated: January 3, 2017
Last Verified: January 2017