Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV
Status: | Completed |
---|---|
Conditions: | Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | January 2014 |
End Date: | December 2014 |
A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection
To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C
virus (HCV) Genotype 3 infection
virus (HCV) Genotype 3 infection
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Key Inclusion Criteria:
- Subjects must be able to understand and agree to comply with the prescribed dosing
regimens and procedures, report for regularly scheduled study visits, and reliably
communicate with study personnel about adverse events and concomitant medications
- Subjects chronically infected with hepatitis C virus (HCV) genotype 3
- Subjects who are HCV treatment-naive
- Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A
inhibitors is prohibited)
- HCV RNA ≥10,000 IU/mL at screening
Key Exclusion Criteria:
- HCV Genotypes other than genotype-3 infection; mixed genotype infections are not
permitted
- Liver or any other organ transplant (including hematopoietic stem cell transplants)
other than cornea and hair
- Current or known history of cancer (except in situ carcinoma of the cervix or
adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior
to screening
- Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained
imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this
was performed)
- Evidence of decompensated liver disease including, but not limited to, radiologic
criteria, a history or presence of ascites, bleeding varices, or hepatic
encephalopathy
We found this trial at
31
sites
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Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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