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Anti-viral
Treatment AB - Form H (test tablet) first for Smallpox (BCV-001 Trial)
Phase 1
Waitlist Available
Research Sponsored by Emergent BioSolutions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through end of study visit (within 14 days after 2nd dose)
Awards & highlights
BCV-001 Trial Summary
This trial will test if two forms of a drug are safe & effective when given to healthy adults. Participants will take different forms of the drug 14 days apart & be tested to measure safety.
BCV-001 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through end of study visit (within 14 days after 2nd dose)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through end of study visit (within 14 days after 2nd dose)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Chemistry parameter: Albumin/Globulin ratio
Chemistry parameter: Creatinine (g/24h)
Chemistry parameter: LDH (units/L)
+20 moreBCV-001 Trial Design
2Treatment groups
Active Control
Group I: Treatment AB - Form H (test tablet) firstActive Control1 Intervention
Treatment AB:
Participants assigned to Treatment AB in Period 1, will be given a single 100 mg tablet of Form H (test tablet). In Period 2, participants will be given a single 100 mg tablet of Form II (reference tablet) after a 14 day washout period.
Group II: Treatment BA - Form II (reference tablet) firstActive Control1 Intervention
Treatment BA:
Participants assigned to Treatment BA in Period 1, will be given a single 100 mg tablet of Form II (reference tablet). In Period 2, participants will be given a single 100 mg tablet of Form H (test tablet) after a 14 day washout period.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Emergent BioSolutionsLead Sponsor
61 Previous Clinical Trials
937,400 Total Patients Enrolled
8 Trials studying Smallpox
920,203 Patients Enrolled for Smallpox
Dave Cassie, MScStudy DirectorDirector, Clinical Research
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a long-term liver problem or damage, like from heavy drinking, viral infections, or other conditions. However, having had hepatitis A more than a year ago won't prevent you from participating.You had a serious infection like COVID-19, a cold, flu, or high fever within the past two weeks before the study starts.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment AB - Form H (test tablet) first
- Group 2: Treatment BA - Form II (reference tablet) first
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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