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

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Brief Title

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

Official Title

Open-label, Dose-finding, 2-parts, Efficacy Phase II Study With Three Formulations (Racemate Raziquantel Commercial Oral Tablets, New Oral Disintegrating Tablets of Racemate Praziquantel and L-praziquantel) in Schistosomiasis (S. Mansoni) Infected Children Aged 2-6 Years (Part 1), Followed by an Assessment of Efficacy and Safety With the Selected Formulation and Dosage in S. Mansoni Infected Infants Aged 3-24 Months (Part 2)

Brief Summary

      The Phase II study consisted 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 2 investigated efficacy and safety with the selected formulation and dosage in S.
      mansoni infected children aged between 3 months - 2 years.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of Participants With Clinical Cure Determined by Kato-Katz Method

Secondary Outcome

 Egg Reduction Rate (Percent)

Condition

Schistosomiasis

Intervention

Biltricide (racemate praziquantel) oral tablets

Study Arms / Comparison Groups

 Part 1, Cohort 1: Biltricide (racemate praziquantel) 20 mg/kg
Description:  Participants received Biltricide (600 mg tablet) administered orally at a dose of 20 milligram per kilogram (mg/kg), three times a day on treatment Day 1.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

444

Start Date

June 12, 2016

Completion Date

November 17, 2018

Primary Completion Date

October 30, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Male and female children aged 2 to 6 years (Part 1) and 3 to 24 months (Part 2)

          -  S. mansoni positive diagnosis defined as positive egg counts in stool (greater than
             [>]1 egg/1 occasion) according to World Health Organization (WHO) classification :
             light (1-99 eggs per gram of faeces), moderate (100-399 eggs per gram of faeces) and
             heavy (greater than or equal to [>=]400 eggs per gram of faeces) infections

          -  Minimum weight of 8.0 kg in 2- to 6-year-old children and of 4.0 kg in 3- to 24-month
             infants

             • Parents/legal representative ability to communicate well with the Investigator, to
             understand the protocol requirements and restrictions, and willing their children to
             comply with the requirements of the entire trial, i.e.

          -  To be examined by a study physician at screening and 14-21 days after treatment

          -  To provide stool and urine samples at screening, 24 hours and 8 days after treatment,
             as well as 14-21 days after treatment

          -  To provide finger prick blood samples for Pharmacokinetics (PK) studies and blood
             samples for safety assessments

        Exclusion Criteria:

          -  Treatment in the 4 weeks prior to study screening with Praziquantel (PZQ) , other
             anti-helminthic, antimalarial or anti-retroviral compounds or any other medication
             that might affect the PK of PZQ such as certain antiepileptics (e.g., carbamazepine or
             phenytoin), glucocorticosteroids (e.g., dexamethasone), chloroquine, rifampicin or
             cimetidine

          -  For children being breast fed, treatment of the mothers/wet nurses with PZQ in the 3
             days prior to administration of Investigational medicinal product

          -  Previous history of adverse reactions associated with PZQ treatment

          -  Marked increases of the liver transaminases (alanine aminotransferase and/or aspartate
             aminotransferase) above 3x Upper Limit of Normal (ULN)

          -  History of acute or severe chronic disease including hepato-splenic schistosomiasis

          -  Fever defined as temperature above 38.0 degree centigrade

          -  Debilitating illnesses such as tuberculosis, malnutrition, etc. as well as a medical
             history of seizures

          -  Mixed S. haematobium and S. mansoni infections

          -  Findings in the clinical examination of schistosome-infected children participating in
             the study as performed by the study clinician on the treatment day, that in the
             opinion of the Investigator constitutes a risk or a contraindication for the
             participation of the subject in the study or that could interfere with the study
             objectives, conduct or evaluation

          -  Unlikelihood to comply with the protocol requirements, instructions and trial-related
             restrictions, e.g., uncooperative attitude, inability to return for follow-up visits,
             and improbability of completing the trial
      

Gender

All

Ages

3 Months - 6 Years

Accepts Healthy Volunteers

No

Contacts

Medical Responsible, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT02806232

Organization ID

200661-0005


Responsible Party

Sponsor

Study Sponsor

Merck KGaA, Darmstadt, Germany


Study Sponsor

Medical Responsible, Study Director, Merck KGaA, Darmstadt, Germany


Verification Date

October 2019