- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03845140
L-PZQ ODT in Schistosoma Infected Children
September 8, 2023 updated by: Merck KGaA, Darmstadt, Germany
An Open Label, Phase III Efficacy and Safety Study of 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®)
The study would evaluate the safety and efficacy of L-praziquantel orodispersible (L-PZQ ODT) tablets in Schistosoma infected children aged 3 months to 6 years.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
288
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Abidjan, Côte D'Ivoire, 22BP770
- Universitè de Cocody
-
-
-
-
-
Kisumu, Kenya, 40100
- Kemri Kisumu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 months to 6 years (Child)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1a: 4 to 6 years L-PZQ ODT 50 mg/kg
Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams [mg]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.
|
Participants received single oral dose of L-PZQ ODT 50 mg/Kg on Day 1.
|
Active Comparator: Cohort 1b: 4 to 6 years Biltricide® 40 mg/kg
Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.
|
Participants received single oral dose of Biltricide® 40 mg/kg on Day 1.
|
Experimental: Cohort 2: 2 to 3 years L-PZQ ODT 50 mg/kg
Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.
|
Participants received single oral dose of L-PZQ ODT 50 mg/Kg on Day 1.
|
Experimental: Cohort 3: 3 to 24 months L-PZQ ODT 50 mg/kg
Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.
|
Participants received single oral dose of L-PZQ ODT 50 mg/Kg on Day 1.
|
Experimental: Cohort 4a: 3 months to 6 years L-PZQ ODT 50 mg/kg
Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.
|
Participants received single oral dose of L-PZQ ODT 50 mg/Kg on Day 1.
|
Experimental: Cohort 4b: 3 months to 6 years L-PZQ ODT 60 mg/kg
Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
|
Participant received single oral dose of L-PZQ ODT 60 mg/kg on Day 1.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cohort 1a and Cohort 1b: Number of Participants With Clinical Cure Determined by Kato-Katz Method
Time Frame: at Week 3
|
Clinical cure was defined as no parasite egg in the stool at Week 3 as determined by the Kato-Katz method.
Number of participants with clinical cure were reported.
|
at Week 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cohort 2 and Cohort 3: Number of Participants With Clinical Cure Determined by Kato-Katz Method
Time Frame: at Week 3
|
Clinical cure was defined as no parasite egg in the stool at Week 3 as determined by the Kato-Katz method.
Number of participants with clinical cure were reported.
|
at Week 3
|
Cohort 4a and Cohort 4b: Number of Participants With Clinical Cure Determined by Urine Filtration Technique
Time Frame: Week 3 and Week 5
|
Clinical cure was defined as no parasite egg in the urine samples at follow up as determined by the urine filtration technique.
Number of participants with clinical cure were reported.
|
Week 3 and Week 5
|
Cohort 1a, Cohort 1b, Cohort 2 and Cohort 3: Egg Reduction Rate (Percent [%]) Determined by Kato-Katz Method
Time Frame: Pre-treatment, Week 3 post-treatment
|
Percentage of reduction in group mean egg count was calculated as relative difference between the post-treatment arithmetic mean egg count and pre-treatment arithmetic mean egg count at baseline count, (pre-treatment mean egg count minus post-treatment mean egg count divided by pre-treatment mean egg count) *100.
Egg counts were determined by the Kato-Katz method.
|
Pre-treatment, Week 3 post-treatment
|
Cohort 4a and Cohort 4b: Egg Reduction Rate (Percent [%]) Determined by Urine Filtration Technique
Time Frame: Pre-treatment, Weeks 3 and 5 post-treatment
|
Percentage of reduction in group mean egg count was calculated as relative difference between the post-treatment arithmetic mean egg count and pre-treatment arithmetic mean egg count at baseline count, (pre-treatment mean egg count minus post-treatment mean egg count divided by pre-treatment mean egg count) *100.
Egg counts were determined by the urine filtration technique.
|
Pre-treatment, Weeks 3 and 5 post-treatment
|
Cohort 1a, Cohort 1b, Cohort 2, and Cohort 3: Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test
Time Frame: at Week 3
|
Clinical cure is defined as absence of test line in the POC-CCA test cassette (that is no Schistosoma antigens detected).
Number of participants with clinical cure were reported.
|
at Week 3
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs
Time Frame: up to Day 40
|
Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment.
Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect.
TEAEs: TEAEs were defined as those events with onset dates/time occurring after study intervention administration or events that worsen after study intervention administration.
TEAEs included serious TEAEs and non-serious TEAEs.
Treatment-related TEAEs: reasonably related to the study intervention.
|
up to Day 40
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale
Time Frame: up to Day 40
|
Severity of TEAEs were graded using Qualitative Toxicity Scale, as follows: Mild: Participant is aware of the event or symptom, but the event or symptom is easily tolerated; Moderate: Participant experiences sufficient discomfort to interfere with or reduce his or her usual level of activity; Severe: Significant impairment of functioning: the participant is unable to carry out his or her usual activities.
Number of participants with TEAEs by severity were reported.
|
up to Day 40
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin
Time Frame: Baseline, Day 1
|
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.
Change from baseline in hematology parameter: erythrocytes mean corpuscular hemoglobin at Day 1 were reported.
|
Baseline, Day 1
|
Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin
Time Frame: Baseline, Day 1
|
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin.
Change from baseline in hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin at Day 1 were reported.
|
Baseline, Day 1
|
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume
Time Frame: Baseline, Day 1
|
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes mean corpuscular volume.
Change from baseline in hematology parameter: erythrocytes mean corpuscular volume at Day 1 were reported.
|
Baseline, Day 1
|
Change From Baseline in Hematology Parameter: Erythrocytes
Time Frame: Baseline, Day 1
|
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes.
Change from baseline in hematology parameter: erythrocytes at Day 1 were reported.
|
Baseline, Day 1
|
Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes
Time Frame: Baseline, Day 1
|
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: hematocrit, lymphocytes/leukocytes, mixed cells/leukocytes, neutrophils/leukocytes.
Change from baseline in hematology parameters: hematocrit, lymphocytes/leukocytes, mixed cells/leukocytes, neutrophils/leukocytes at Day 1 were reported.
|
Baseline, Day 1
|
Change From Baseline in Hematology Parameters: Leukocytes and Platelets
Time Frame: Baseline, Day 1
|
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: leukocytes and platelets.
Change from baseline in hematology parameters: leukocytes and platelets at Day 1 were reported.
|
Baseline, Day 1
|
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase
Time Frame: Baseline, Day 1
|
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: Alanine Aminotransferase and Aspartate Aminotransferase.
Change from baseline in chemistry parameters: Alanine Aminotransferase and Aspartate Aminotransferase at Day 1 were reported.
|
Baseline, Day 1
|
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin
Time Frame: Baseline, Day 1
|
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: bilirubin, creatinine and direct bilirubin.
Change from baseline in chemistry parameters: bilirubin, creatinine and direct bilirubin at Day 1 were reported.
|
Baseline, Day 1
|
Change From Baseline in Chemistry Parameter: C Reactive Protein
Time Frame: Baseline, Day 1
|
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: C reactive protein.
Change from baseline in chemistry parameter: C reactive protein at Day 1 were reported.
|
Baseline, Day 1
|
Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen
Time Frame: Baseline, Day 1
|
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: glucose, urea and urea nitrogen.
Change from baseline in chemistry parameters: glucose, urea and urea nitrogen at Day 1 were reported.
|
Baseline, Day 1
|
Change From Baseline in Chemistry Parameter: Total Protein
Time Frame: Baseline, Day 1
|
Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: total Protein.
Change from baseline in chemistry parameter: total Protein at Day 1 were reported.
|
Baseline, Day 1
|
Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine
Time Frame: Baseline, Day 1
|
Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameters: specific gravity.
Change from baseline in urinalyses parameter: specific gravity Day 1 was reported.
|
Baseline, Day 1
|
Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine
Time Frame: Baseline, Day 1
|
Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: pH.
Change from baseline in urinalyses parameter: pH at Day 1 was reported.
|
Baseline, Day 1
|
Change From Baseline in Urinalyses Parameter: Urobilinogen
Time Frame: Baseline, Day 1
|
Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: urobilinogen.
Change from baseline in urinalyses parameter: urobilinogen at Day 1 were reported.
|
Baseline, Day 1
|
Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure
Time Frame: Baseline, Week 3
|
Diastolic blood pressure and systolic blood pressure were measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions.
Change from baseline in vital signs: diastolic blood pressure and systolic blood pressure at Week 3 were reported.
|
Baseline, Week 3
|
Change From Baseline in Vital Signs: Pulse Rate
Time Frame: Baseline, Week 3
|
Pulse rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions.
Change from baseline in vital sign: pulse rate at Week 3 was reported.
|
Baseline, Week 3
|
Change From Baseline in Vital Sign: Respiratory Rate
Time Frame: Baseline, Week 3
|
Respiratory rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions.
Change from baseline in vital sign: respiratory rate at Week 3 was reported.
|
Baseline, Week 3
|
Change From Baseline in Vital Signs: Temperature
Time Frame: Baseline, Week 3
|
Temperature was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions.
Change from baseline in vital sign: temperature at Week 3 was reported.
|
Baseline, Week 3
|
Number of Participants With Reaction to Study Intervention Administration
Time Frame: Day 1
|
Reaction to study intervention administration were recorded to describe tolerability as assessed by nurse/site staff for all children enrolled in the study.
Reactions categorized as spitting, crying, diarrheas, sleepiness, abdominal pain, fever, vomiting and other.
Number of participants with reaction to study intervention administration reported.
|
Day 1
|
Cohort 1a, Cohort 1b, Cohort 4a and Cohort 4b: Palatability Assessment Based on Visual Analog Scale (VAS) Score
Time Frame: Day 1
|
Palatability of the study intervention was assessed using a human gustatory sensation test (100-millimeter [mm] visual analog scale [VAS]) incorporating a facial hedonic scale, where lower score (0) indicates "not acceptable/not liked at all" and higher score (100) indicates "very acceptable/liked very much".
|
Day 1
|
Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ
Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose
|
Cmax was obtained directly from the plasma concentration versus time curve.
|
Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose
|
Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ
Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose
|
Tmax was obtained directly from the plasma concentration versus time curve.
|
Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ
Time Frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose
|
Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ).
AUC0-t was calculated according to the mixed log-linear trapezoidal rule.
|
Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Responsible, Merck KGaA, Darmstadt, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 2, 2019
Primary Completion (Actual)
October 11, 2021
Study Completion (Actual)
October 11, 2021
Study Registration Dates
First Submitted
February 15, 2019
First Submitted That Met QC Criteria
February 15, 2019
First Posted (Actual)
February 19, 2019
Study Record Updates
Last Update Posted (Actual)
March 21, 2024
Last Update Submitted That Met QC Criteria
September 8, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS200661_0003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
We are committed to enhancing public health through responsible sharing of clinical trial data.
Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research.
Further information on how to request data can be found on our website bit.ly/IPD21
IPD Sharing Time Frame
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
IPD Sharing Access Criteria
Qualified scientific and medical researchers can request the data.
Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schistosomiasis
-
Oswaldo Cruz FoundationRecruitingVaccination; Infection | Schistosomiasis Mansoni | Schistosomiasis HaematobiumSenegal
-
Rhode Island HospitalLondon School of Hygiene and Tropical Medicine; Medical Research Council; University... and other collaboratorsRecruitingSchistosomiasis | Schistosomiasis Mansoni | Schistosoma Japonicum InfectionUganda, United Kingdom
-
Leiden University Medical CenterCompletedSchistosomiasis | Schistosomiasis MansoniNetherlands
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...Completed
-
Oswaldo Cruz FoundationUniversidade Federal de Pernambuco; World Health OrganizationCompletedSchistosomiasis Mansoni
-
Enaiblers ABMinistry of Health, Uganda; Jimma University; Ghent University, BelgiumNot yet recruitingSchistosomiasis Mansoni | Soil Transmitted Helminths
-
IRCCS Sacro Cuore Don Calabria di NegrarActive, not recruiting
-
Makerere UniversityUniversity of CopenhagenCompleted
-
Makerere UniversityUniversity of CopenhagenUnknown
Clinical Trials on L-PZQ ODT 50 mg/kg
-
Merck KGaA, Darmstadt, GermanySwiss Tropical & Public Health InstituteCompleted
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedHealthy VolunteersUnited States
-
Crucell Holland BVNational Institute of Allergy and Infectious Diseases (NIAID)Completed
-
Crucell Holland BVNational Institute of Allergy and Infectious Diseases (NIAID)Completed
-
Fundacion para la Investigacion Biomedica del Hospital...Completed
-
Merck Sharp & Dohme LLCCompletedUrinary Incontinence
-
Moleculin Biotech, Inc.Active, not recruitingSarcoma,Soft Tissue | Pulmonary MetastasisUnited States
-
Peking University Cancer Hospital & InstituteUnknownBiliary Tract CancerChina
-
Oregon Health and Science UniversityCompletedSubstance Abuse, Intravenous | Hepatitis C | Substance Use DisordersUnited States
-
University Health Network, TorontoActive, not recruitingAxial SpondyloarthritisCanada