Study of CDI-31244 in Combination With Sofosbuvir (SOF) and Velpatasvir (VEL)



Status:Active, not recruiting
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:9/14/2018
Start Date:June 26, 2018
End Date:April 30, 2019

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Trial Summary
Trial Overview
Inclusion Criteria

An Open-Label Phase 2a Study Evaluating the Safety and Efficacy of Combination Treatment With 2 Weeks of the Non-Nucleoside Inhibitor CDI 31244 Plus 6 Weeks of Sofosbuvir/Velpatasvir in Subjects With Chronic Hepatitis C Genotype 1 Infection

Open label phase 2a study of two week treatment with CDI-31244 and sofosbuvir and veltapasvir
followed by four week treatment of sofosbuvir and velpatasvir in individuals with chronic
hepatitis C (HCV) genotype 1 (GT1) infection

The study is open label and has one treatment group. Eligible HCV GT1 subjects will self
administer orally 400 mg of CDI-31244 and fixed dose combination of sofosbuvir and
velpatasvir for 14 days. After 14 days the subjects will continue the treatment for another 4
weeks on the fixed dose combination sofosbuvir and velpatasvir. The subjects will be followed
up until 24 weeks after the last dose of sofosbuvir and velpatasvir to determine if sustained
virologic response at 12 (SVR12) and 24 (SVR24) weeks after treatment have been achieved.

Key Inclusion Criteria:

Documented chronic HCV GT 1 infection; Serum HCV RNA >1,000 IU/mL during screening; Absence
of advanced fibrosis or cirrhosis

Key Exclusion Criteria:

Nursing or pregnant women; Active hepatitis B infection; Human immunodeficiency virus (HIV)
infection; History of use of any HCV direct-acting antiviral therapy
We found this trial at
1
site
Institute of Human Virology, University of Maryland
Baltimore, Maryland 21201
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mi
from
Baltimore, MD
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