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DAG181

Phase 3

Chronic HCV Infection | Small molecule | Infectious Disease |Sunshine Biopharma Inc.|Last Updated: Mar 18, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment491

FDA Designations

No designations recorded

Clinical trial landscape

DAG181 · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT03487107Phase 3 Study of Yimitasvir Phosphate CapsulesChronic HCV Infection
COMPLETED362 Analytics
PHASE3COMPLETED
Phase 3 Study of Yimitasvir Phosphate Capsules
Chronic HCV InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of subjects with sustained virologic response 12 weeks after discontinuation of therapy(SVR12)
Posttreatment Week 12

SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after discontinuation of therapy

Safety and tolerability were evaluated based on adverse events
Up to posttreatment week 24

Collecting all adverse events during the whole study

Percentage of subjects with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
Posttreatment Week 12

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment

Safety and tolerability were evaluated based on adverse event monitoring, laboratory tests, 12-lead ECG assessments, vital signs measurements and physical examinations.
Up to posttreatment week 24

Secondary Endpoints

Percentage of subjects with sustained virologic response 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)
Posttreatment Weeks 4 and 24
HCV RNA change from baseline
Up to posttreatment week 24
Percentage of subjects with virologic failure
Up to posttreatment week 24
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SOF 400 mg+DAG181 100 mgEXPERIMENTALPatients with genotype 1 HCV infection without cirrhosis will receive SOF 400 mg+DAG181 100 mg for 12 weeks.
SOF+DAG181 100 mgEXPERIMENTALPatients with genotype 1 HCV infection without cirrhosis will receive SOF+DAG181 100 mg for 12 weeks.
SOF+DAG181 200 mgEXPERIMENTALPatients with genotype 1 HCV infection without cirrhosis will receive SOF+DAG181 200 mg for 12 weeks.

Interventions

NameTypeDescription
SOFDRUG400 mg tablet administered orally once daily
DAG181DRUG100 mg capsule administered orally once daily
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: 1. Willing and able to provide written informed consent; 2. Male or female, age≥18 years; 3. A female subject is eligible to enter the study if it is confirmed that she is: 1. Of non-childbearing potential (i.e., women who have had a hysterectomy, have both ovaries removed o...

Countries:China
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