L-praziquantel Orodispersible Tablets (L-PZQ ODT) in Schistosoma Infected Children

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Brief Title

L-praziquantel Orodispersible Tablets (L-PZQ ODT) in Schistosoma Infected Children

Official Title

An Open Label, Phase III Efficacy and Safety Study of L Praziquantel Orodispersible Tablets (L-PZQ ODT) in Schistosoma Infected Children 3 Months to 6 Years of Age, Including a 2:1 Randomized, Controlled Cohort of Schistosoma Mansoni Infected Children 4 to 6 Years of Age Treated With L PZQ ODT or Commercial PZQ (Biltricide®)

Brief Summary

      The study will evaluate the safety and efficacy of L-praziquantel orodispersible (L-PZQ ODT)
      tablets in Schistosoma infected children aged 3 months to 6 years.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Numbers of Participants With Clinical Cure

Secondary Outcome

 Egg Reduction Rate

Condition

Schistosomiasis

Intervention

L-PZQ ODT

Study Arms / Comparison Groups

 Cohort 1, Treatment 1a: L-PZQ ODT
Description:  Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni will receive single oral dose of L-PZQ ODT 50 milligram/Kilogram (mg/Kg) after food-intake.

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

311

Start Date

September 2, 2019

Completion Date

August 30, 2020

Primary Completion Date

August 30, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Age of the participant is 4 to 6 years of age (Cohorts 1 and 4), 2 to 3 years of age
             (Cohorts 2 and 4) 3 to less than 24 months of age (Cohorts 3 and 4)

          -  Participants are; Schistosoma (S.) mansoni positive (Cohorts 1, 2, and 3); diagnosis
             defined as positive egg counts in stool greater than or equal to ( >=) 1 egg per 1
             occasion) according to World Health Organization (WHO) classification [1]: light (1 to
             99 eggs per gram of feces), moderate (100 to 399 eggs per gram of feces) and heavy (>=
             400 eggs per gram of feces) infections; S. haematobium positive (Cohort 4); diagnosis
             defined as positive egg counts in urine (>= 1 egg per 10 milliliter(mL) urine)
             according to WHO classification (Prevention and Control of Schistosomiasis and Soil
             Transmitted Helminthiasis. WHO Technical Report Series No. 912. WHO, Geneva,
             Switzerland, 2002).light (less than (<) 50 eggs per 10 mL of urine) and heavy (>=50
             eggs per 10 mL of urine) infections

          -  Participants have a minimum body weight of 8.0 Kilograms (Kg) in 2 to 6 years of age
             children and 5.0 Kg in 3 months to < 24 months of age infants and toddlers

          -  Parent's or guardian/legally authorized representative's ability to communicate well
             with the Investigator and his/her delegate, to understand the protocol requirements
             and restrictions, and to be willing to have their children comply with the
             requirements of the entire study, that is:

               -  To be examined by a study physician at screening and 17 to 21 days after
                  treatment

               -  To provide stool samples at screening and 17 to 21 days after treatment

               -  To provide urine samples at screening and 17 to 21 days after treatment

               -  To provide venous blood samples for laboratory assessments

               -  To be housed in the clinic for 12 to 24 hours

               -  To provide venous blood samples for pharmacokinetics (PK) assessments (for
                  participants in the PK subset)

          -  Participants have a minimum hemoglobin level of 10 gram per deciliter

        Exclusion Criteria:

          -  Participants with following medical conditions are excluded from the study; Findings
             in the clinical examination and/or laboratory safety examination on the treatment day,
             that in the opinion of the Investigator constitute a risk or a contraindication for
             the child's participation in the study or that could interfere with the study
             objectives, conduct or evaluation. This includes but is not restricted to bacterial or
             viral infections, such as dysentery, gastroenteritis, ascites, jaundice, etc.;
             Participants with seizures and/or medical history of seizures and/or other signs of
             potential central nervous system involvement; Participants with known cysticercosis,
             or with signs or symptoms (for example: subcutaneous nodules) suggestive of
             cysticercosis; Participants with an acute infection or other acute illness within the
             7 days prior to study screening; Debilitating illness such as tuberculosis,
             malnutrition, etc.

          -  Treatment with PZQ within the 4 weeks prior to the study screening

          -  Concomitant treatment (within 2 weeks prior to enrollment) with medication that might
             affect the metabolism of PZQ, such as certain anti epileptics (for example:
             carbamazepine or phenytoin), glucocorticosteroids (for example: dexamethasone),
             chloroquine, rifampicin or cimetidine (see Biltricide® Summary of Product
             Characteristics [SmPC])

          -  Treatment within the 2 weeks prior to the study screening with anti malarial
             medications

          -  For infants and toddlers being breast fed, treatment of the mothers/wet nurses with
             PZQ in the 3 days prior to PZQ ODT administration

          -  Participation in any clinical study within 4 weeks prior to administration of PZQ ODT,
             or anticipated at any time until completion of the End of study visit

          -  Participants with marked increases of the liver enzymes: alanine aminotransferase
             and/or aspartate aminotransferase above 3 times the upper limit of normal (ULN); total
             bilirubin level above 1.5 times the ULN

          -  Participants with hepatosplenic schistosomiasis

          -  Fever, defined as temperature above 37.5 degree Celsius axillary or oral mixed S.
             haematobium and S. mansoni infections
      

Gender

All

Ages

3 Months - 6 Years

Accepts Healthy Volunteers

No

Contacts

Medical Responsible, +49 6151 72 5200, [email protected]

Location Countries

Côte D'Ivoire

Location Countries

Côte D'Ivoire

Administrative Informations


NCT ID

NCT03845140

Organization ID

MS200661_0003


Responsible Party

Sponsor

Study Sponsor

Merck KGaA, Darmstadt, Germany


Study Sponsor

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


Verification Date

March 2020