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

NCT02806232 | Completed Phase 2 Results DMC

• 1 other identifier: 200661-0005
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

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.

Conditions

Schistosomiasis

Keywords

Praziquantel ODT formulation; Biltricide

Outcome Measures

Primary Outcomes (1)

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

  Clinical cure was defined as zero egg counts at 14-21 days post treatment as determined by the Kato-Katz method. Number of participants with clinical cure were reported.

  14-21 days post treatment

Secondary Outcomes (2)

• Egg Reduction Rate (Percent)

  Baseline, 14-21 days post treatment

• Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test

  Day 2, Day 8 and 14-21 days post treatment

Study Arms (9)

Part 1, Cohort 1: Biltricide (racemate praziquantel) 20 mg/kg

EXPERIMENTAL

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.

Drug: Biltricide (racemate praziquantel) oral tablets

Part 1, Cohort 2: Biltricide (racemate praziquantel) 40 mg/kg

EXPERIMENTAL

Participants received Biltricide (600 mg tablet) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.

Drug: Biltricide (racemate praziquantel) oral tablets

Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg

EXPERIMENTAL

Participants received Racemate Praziquantel oral dispersible tablet (ODT) (150 mg) administered orally at a dose of 40 mg/kg as a single dose on treatment Day 1.

Drug: Racemate Praziquantel ODT

Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg

EXPERIMENTAL

Participants received Racemate Praziquantel ODT (150 mg) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.

Drug: Racemate Praziquantel ODT

Part 1, Cohort 5: Levo Praziquantel 30 mg/kg

EXPERIMENTAL

Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 30 mg/kg as a single dose on treatment Day 1.

Drug: Levo Praziquantel ODT

Part 1, Cohort 6: Levo Praziquantel 45 mg/kg

EXPERIMENTAL

Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 45 mg/kg as a single dose on treatment Day 1.

Drug: Levo Praziquantel ODT

Part 1, Cohort 7: Levo Praziquantel 60 mg/kg

EXPERIMENTAL

Participants received Levo Praziquantel ODT (150 mg tablet) administered orally at a dose of 60 mg/kg as a single dose on treatment Day 1.

Drug: Levo Praziquantel ODT

Part 2, Cohort 8: Levo Praziquantel 50 mg/kg

EXPERIMENTAL

Participants aged 13-24 months months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.

Drug: Levo Praziquantel ODT

Part 2, Cohort 9: Levo Praziquantel 50 mg/kg

EXPERIMENTAL

Participants aged 3 to 12 months received Levo Praziquantel ODT (150 mg) administered orally at a dose of 50 mg/kg as a single dose on treatment day 1.

Drug: Levo Praziquantel ODT

Interventions

Biltricide (racemate praziquantel) oral tablets DRUG

Biltricide (600 mg tablet) was administered to participants at a dose of 20 mg/kg in Part 1, Cohort 1 and at a dose of 40mg/kg in Part 1, Cohort 2.

Part 1, Cohort 1: Biltricide (racemate praziquantel) 20 mg/kg; Part 1, Cohort 2: Biltricide (racemate praziquantel) 40 mg/kg

Racemate Praziquantel ODT DRUG

Racemate Praziquantel (PZQ) (150) mg was administered at a dose of 40 mg/kg in Part 1, Cohort 3 and at a dose of 60 mg/kg in Part 1, Cohort 4.

Part 1, Cohort 3: Racemate Praziquantel 40 mg/kg; Part 1, Cohort 4: Racemate Praziquantel 60 mg/kg

Levo Praziquantel ODT DRUG

Levo PZQ (150 mg) was administered at a dose of 30 mg/kg in Part 1 Cohort 5, 45 mg/kg Part 1 Cohort 6, 60 mg/kg Part 1 Cohort 7, 50 mg/kg Part 2 Cohort 8, and 50 mg/kg Part 2 Cohort 9.

Part 1, Cohort 5: Levo Praziquantel 30 mg/kg; Part 1, Cohort 6: Levo Praziquantel 45 mg/kg; Part 1, Cohort 7: Levo Praziquantel 60 mg/kg; Part 2, Cohort 8: Levo Praziquantel 50 mg/kg; Part 2, Cohort 9: Levo Praziquantel 50 mg/kg

Eligibility Criteria

• Age: 3 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Please Contact the Communication Center

Darmstadt, Germany

Location

MeSH Terms

Conditions

Schistosomiasis

Interventions

Praziquantel

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Communication Center
• Organization: Merck KGaA, Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 20, 2016
• Study Start: June 12, 2016
• Primary Completion: October 30, 2018
• Study Completion: November 17, 2018
• Last Updated: November 20, 2019
• Results First Posted: November 20, 2019

Record last verified: 2019-10

Locations

DE (1)